| Abacavir Sulfate |
Oral |
Tablet |
020977 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Abacavir Sulfate; Dolutegravir Sodium; Lamivudine |
Oral |
Tablet |
205551 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Abacavir Sulfate; Dolutegravir Sodium; Lamivudine |
Oral |
Tablet, For Suspension |
215413 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Abacavir Sulfate; Lamivudine |
Oral |
Tablet |
021652 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Abacavir Sulfate; Lamivudine; Zidovudine |
Oral |
Tablet |
021205 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Abemaciclib |
Oral |
Tablet |
208716 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Abrocitinib |
Oral |
Tablet |
213871 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Acalabrutinib |
Oral |
Capsule |
210259 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Acetaminophen; Aspirin; Caffeine |
Oral |
Tablet |
020802 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Acetaminophen; Benzhydrocodone Hydrochloride |
Oral |
Tablet |
208653 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Acetaminophen; Butalbital; Caffeine; Codeine Phosphate |
Oral |
Capsule |
020232 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Acetaminophen; Ibuprofen |
Oral |
Tablet |
211733 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Acetaminophen; Propoxyphene Napsylate |
Oral |
Tablet |
017122 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Acetaminophen; Tramadol Hydrochloride |
Oral |
Tablet |
021123 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Acetazolamide |
Oral |
Tablet |
008943 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Acetylcysteine |
Oral |
Tablet, Effervescent |
207916 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Acrivastine; Pseudoephedrine Hydrochloride |
Oral |
Capsule |
019806 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Acyclovir |
Oral |
Capsule |
018828 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Acyclovir |
Oral |
Suspension |
019909 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Acyclovir |
Oral |
Tablet |
020089 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Adagrasib |
Oral |
Tablet |
216340 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Adefovir Dipivoxil |
Oral |
Tablet |
021449 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Albuterol Sulfate |
Oral |
Tablet |
017853 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Allopurinol; Lesinurad |
Oral |
Tablet |
209203 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Almotriptan Malate |
Oral |
Tablet |
021001 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Alogliptin Benzoate |
Oral |
Tablet |
022271 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Alogliptin Benzoate; Metformin Hydrochloride |
Oral |
Tablet |
203414 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Alogliptin Benzoate; Pioglitazone Hydrochloride |
Oral |
Tablet |
022426 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Alosetron Hydrochloride |
Oral |
Tablet |
021107 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Alprazolam |
Oral |
Tablet |
018276 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Alprazolam |
Oral |
Tablet, Orally Disintegrating |
021726 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Amantadine Hydrochloride |
Oral |
Capsule |
016020 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Amantadine Hydrochloride |
Oral |
Tablet |
018101 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ambrisentan |
Oral |
Tablet |
022081 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Amifampridine Phosphate |
Oral |
Tablet |
208078 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Amiloride Hydrochloride |
Oral |
Tablet |
018200 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Aminocaproic Acid |
Oral |
Tablet |
015197 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Amiodarone Hydrochloride |
Oral |
Tablet |
018972 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Amitriptyline Hydrochloride |
Oral |
Tablet |
012703 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Amitriptyline Hydrochloride; Chlordiazepoxide |
Oral |
Tablet |
016949 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Amlodipine Benzoate |
Oral |
Suspension |
211340 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Amlodipine Besylate |
Oral |
Tablet |
019787 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Amlodipine Besylate; Atorvastatin Calcium |
Oral |
Tablet |
021540 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Amlodipine Besylate; Benazepril Hydrochloride |
Oral |
Capsule |
020364 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Amlodipine Besylate; Celecoxib |
Oral |
Tablet |
210045 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Amlodipine Besylate; Hydrochlorothiazide; Olmesartan Medoxomil |
Oral |
Tablet |
200175 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Amlodipine Besylate; Hydrochlorothiazide; Valsartan |
Oral |
Tablet |
022314 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Amlodipine Besylate; Olmesartan Medoxomil |
Oral |
Tablet |
022100 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Amlodipine Besylate; Perindopril Arginine |
Oral |
Tablet |
205003 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Amlodipine Besylate; Valsartan |
Oral |
Tablet |
021990 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Amoxicillin |
Oral |
Capsule |
050459 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Amoxicillin |
Oral |
For Suspension |
050460 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Amoxicillin |
Oral |
Tablet, Chewable |
050542 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Amoxicillin |
Oral |
For Suspension |
050760 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Amoxicillin; Clarithromycin; Vonoprazan Fumarate |
Oral |
Capsule, Tablet, Tablet |
215152 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Amoxicillin; Clavulanate Potassium |
Oral |
For Suspension |
050575 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Amoxicillin; Clavulanate Potassium |
Oral |
Tablet, Chewable |
050597 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Amoxicillin; Clavulanate Potassium |
Oral |
Tablet, Chewable |
050726 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Amoxicillin; Clavulanate Potassium |
Oral |
Tablet |
050564; 050720 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Amoxicillin; Clavulanate Potassium |
Oral |
For Suspension |
050725; 050755 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Amoxicillin; Vonoprazan Fumarate |
Oral |
Capsule, Tablet |
215153 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate |
Oral |
Tablet |
011522 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Anagrelide Hydrochloride |
Oral |
Capsule |
020333 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Anastrozole |
Oral |
Tablet |
020541 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Apixaban |
Oral |
Tablet |
202155 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Apremilast |
Oral |
Tablet |
205437 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Aripiprazole |
Oral |
Tablet |
021436 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Aripiprazole |
Oral |
Tablet, Orally Disintegrating |
021729 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Armodafinil |
Oral |
Tablet |
021875 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Aspirin |
Oral |
Capsule |
203697 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Aspirin; Butalbital; Caffeine; Codeine Phosphate |
Oral |
Capsule |
019429 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Atazanavir Sulfate |
Oral |
Capsule |
021567 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Atazanavir Sulfate; Cobicistat |
Oral |
Tablet |
206353 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Atenolol |
Oral |
Tablet |
018240 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Atenolol; Chlorthalidone |
Oral |
Tablet |
018760 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Atomoxetine Hydrochloride |
Oral |
Capsule |
021411 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Atorvastatin Calcium |
Oral |
Tablet |
020702 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Atorvastatin Calcium |
Oral |
Suspension |
213260 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Atorvastatin Calcium; Ezetimibe |
Oral |
Tablet |
200153 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Atovaquone |
Oral |
Tablet |
020259 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Atovaquone |
Oral |
Suspension |
020500 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Auranofin |
Oral |
Capsule |
018689 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Avanafil |
Oral |
Tablet |
202276 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Avatrombopag Maleate |
Oral |
Tablet |
210238 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Axitinib |
Oral |
Tablet |
202324 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Azilsartan Kamedoxomil |
Oral |
Tablet |
200796 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Azilsartan Kamedoxomil; Chlorthalidone |
Oral |
Tablet |
202331 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Azithromycin |
Oral |
For Suspension |
050693 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Azithromycin |
Oral |
For Suspension |
050710 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Azithromycin |
Oral |
Tablet |
050711; 050730; 050784 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Baclofen |
Oral |
Tablet |
017851 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Baclofen |
Oral |
Tablet, Orally Disintegrating |
021589 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Baclofen |
Oral |
Granules |
215422 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Baclofen |
Oral |
Suspension |
215602 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Baloxavir Marboxil |
Oral |
Tablet |
210854 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Baloxavir Marboxil |
Oral |
For Suspension |
214410 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Baricitinib |
Oral |
Tablet |
207924 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Bedaquiline Fumarate |
Oral |
Tablet |
204384 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Belumosudil Mesylate |
Oral |
Tablet |
214783 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Bempedoic Acid |
Oral |
Tablet |
211616 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Bempedoic Acid; Ezetimibe |
Oral |
Tablet |
211617 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Benazepril Hydrochloride |
Oral |
Tablet |
019851 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Benazepril Hydrochloride; Hydrochlorothiazide |
Oral |
Tablet |
020033 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Benznidazole |
Oral |
Tablet |
209570 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Berotralstat Hydrochloride |
Oral |
Capsule |
214094 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Bexagliflozin |
Oral |
Tablet |
214373 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Bicalutamide |
Oral |
Tablet |
020498 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Binimetinib |
Oral |
Tablet |
210498 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Bisoprolol Fumarate |
Oral |
Tablet |
019982 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Bisoprolol Fumarate; Hydrochlorothiazide |
Oral |
Tablet |
020186 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Boceprevir |
Oral |
Capsule |
202258 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Bosentan |
Oral |
Tablet |
021290 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Bosentan |
Oral |
Tablet, For Suspension |
209279 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Bosutinib Monohydrate |
Oral |
Tablet |
203341 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Brexpiprazole |
Oral |
Tablet |
205422 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Brincidofovir |
Oral |
Tablet |
214461 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Brivaracetam |
Oral |
Tablet |
205836 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Bumetanide |
Oral |
Tablet |
018225 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Bupropion Hydrochloride |
Oral |
Tablet |
018644 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Buspirone Hydrochloride |
Oral |
Tablet |
018731 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Cabotegravir Sodium |
Oral |
Tablet |
212887 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Calcium Carbonate; Famotidine; Magnesium Hydroxide |
Oral |
Tablet, Chewable |
020958 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Canagliflozin |
Oral |
Tablet |
204042 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Canagliflozin; Metformin Hydrochloride |
Oral |
Tablet |
204353 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Candesartan Cilexetil |
Oral |
Tablet |
020838 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Candesartan Cilexetil; Hydrochlorothiazide |
Oral |
Tablet |
021093 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Capmatinib Hydrochloride |
Oral |
Tablet |
213591 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Carbidopa |
Oral |
Tablet |
017830 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Carbidopa; Entacapone; Levodopa |
Oral |
Tablet |
021485 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Carbidopa; Levodopa |
Oral |
Tablet |
017555 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Carbidopa; Levodopa |
Oral |
Tablet, Orally Disintegrating |
078690 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Carglumic Acid |
Oral |
Tablet, For Suspension |
022562 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Cariprazine Hydrochloride |
Oral |
Capsule |
204370 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Carisoprodol |
Oral |
Tablet |
011792 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Carvedilol |
Oral |
Tablet |
020297 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Cefaclor |
Oral |
Capsule |
050521 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Cefadroxil/Cefadroxil Hemihydrate |
Oral |
Capsule |
050512 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Cefdinir |
Oral |
Capsule |
050739 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Cefdinir |
Oral |
For Suspension |
050749 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Cefditoren Pivoxil |
Oral |
Tablet |
021222 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Cefixime |
Oral |
Tablet |
050621 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Cefixime |
Oral |
Tablet, Chewable |
065380 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
02/2025 |
| Cefixime |
Oral |
Capsule |
203195 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Cefixime |
Oral |
For Suspension |
050622; 202091 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Cefpodoxime Proxetil |
Oral |
For Suspension |
050674 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Cefpodoxime Proxetil |
Oral |
Tablet |
050675 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Cefprozil |
Oral |
Tablet |
050664 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Cefprozil |
Oral |
For Suspension |
050665 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Cefuroxime Axetil |
Oral |
Tablet |
050605 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Cefuroxime Axetil |
Oral |
For Suspension |
050672 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Celecoxib |
Capsule |
Oral |
020998 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Celecoxib; Tramadol Hydrochloride |
Oral |
Tablet |
213426 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Cenobamate |
Oral |
Tablet |
212839 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Cephalexin |
Oral |
Capsule |
050405 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Cephalexin |
Oral |
For Suspension |
050406 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ceritinib |
Oral |
Capsule |
205755 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ceritinib |
Oral |
Tablet |
211225 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Cetirizine Hydrochloride |
Oral |
Tablet |
019835 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Cetirizine Hydrochloride |
Oral |
Tablet, Chewable |
021621 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Cetirizine Hydrochloride |
Oral |
Capsule |
022429 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Cetirizine Hydrochloride |
Oral |
Tablet, Orally Disintegrating |
022578 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Cevimeline Hydrochloride |
Oral |
Capsule |
020989 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Chenodiol |
Oral |
Tablet |
018513 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Chlordiazepoxide Hydrochloride |
Oral |
Capsule |
012249 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Chlordiazepoxide Hydrochloride; Clidinium Bromide |
Oral |
Capsule |
012750 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Chlorothiazide |
Oral |
Suspension |
011870 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Chlorpheniramine Maleate; Ibuprofen; Phenylephrine Hydrochloride |
Oral |
Tablet |
022113 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Chlorpheniramine Maleate; Ibuprofen; Pseudoephedrine Hydrochloride |
Oral |
Tablet |
021441 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Chlorpromazine Hydrochloride |
Oral |
Tablet |
084112; 084114 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Chlorthalidone |
Oral |
Tablet |
012283 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Chlorthalidone |
Oral |
Tablet |
019574 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Chlorzoxazone |
Oral |
Tablet |
011529 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Cholic Acid |
Oral |
Capsule |
205750 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Cimetidine |
Oral |
Tablet |
017920 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Cinacalcet Hydrochloride |
Oral |
Tablet |
021688 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ciprofloxacin |
Oral |
For Suspension |
020780 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ciprofloxacin Hydrochloride |
Oral |
Tablet |
019537 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Citalopram Hydrobromide |
Oral |
Tablet |
020822 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Citalopram Hydrobromide |
Oral |
Capsule |
077668 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Citalopram Hydrobromide |
Oral |
Capsule |
215428 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Clarithromycin |
Oral |
Tablet |
050662 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Clarithromycin |
Oral |
For Suspension |
050698 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Clemastine Fumarate |
Oral |
Tablet |
017661 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Clemastine Fumarate |
Oral |
Tablet |
020925 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Clindamycin Hydrochloride |
Oral |
Capsule |
050162 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Clobazam |
Oral |
Tablet |
202067 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Clobazam |
Oral |
Suspension |
203993 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Clomiphene Citrate |
Oral |
Tablet |
016131 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Clomipramine Hydrochloride |
Oral |
Capsule |
019906 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Clonazepam |
Oral |
Tablet |
017533 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Clonazepam |
Oral |
Tablet, Orally Disintegrating |
020813 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Clonidine Hydrochloride |
Oral |
Tablet |
017407 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Clopidogrel Bisulfate |
Oral |
Tablet |
020839 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Clorazepate Dipotassium |
Oral |
Tablet |
017105 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Cobicistat |
Oral |
Tablet |
203094 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Cobimetinib Fumarate |
Oral |
Tablet |
206192 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Colchicine |
Oral |
Tablet |
022352 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Colchicine |
Oral |
Capsule |
204820 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Crizotinib |
Oral |
Capsule |
202570 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Cyclobenzaprine Hydrochloride |
Oral |
Tablet |
017821 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Cycloserine |
Oral |
Capsule |
060593 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
02/2025 |
| Daclatasvir Dihydrochloride |
Oral |
Tablet |
206843 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Dacomitinib |
Oral |
Tablet |
211288 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Dantrolene Sodium |
Oral |
Capsule |
017443 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Dapagliflozin |
Oral |
Tablet |
202293 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Dapagliflozin; Saxagliptin Hydrochloride |
Oral |
Tablet |
209091 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Daprodustat |
Oral |
Tablet |
216951 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Dapsone |
Oral |
Tablet |
086841; 086842 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Daridorexant Hydrochloride |
Tablet |
Oral |
214985 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Darolutamide |
Oral |
Tablet |
212099 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Darunavir |
Oral |
Tablet |
021976 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Darunavir |
Oral |
Suspension |
202895 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Dasatinib |
Oral |
Tablet |
021986 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Deferiprone |
Oral |
Tablet |
021825 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Deflazacort |
Oral |
Tablet |
208684 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Deflazacort |
Oral |
Suspension |
208685 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Delafloxacin Meglumine |
Oral |
Tablet |
208610 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Delavirdine Mesylate |
Oral |
Tablet |
020705 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Desipramine Hydrochloride |
Oral |
Tablet |
014399 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Desloratadine |
Oral |
Tablet |
021165 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Desloratadine |
Oral |
Tablet, Orally Disintegrating |
021312 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Desmopressin Acetate |
Oral |
Tablet |
019955 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Desogestrel; Ethinyl Estradiol |
Oral-28 |
Tablet |
020301 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Desogestrel; Ethinyl Estradiol |
Oral-28 |
Tablet |
020713 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Desogestrel; Ethinyl Estradiol |
Oral-21 |
Tablet |
021090 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Dexamethasone |
Oral |
Tablet |
011664 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Dexmethylphenidate Hydrochloride |
Oral |
Tablet |
021278 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Dexmethylphenidate Hydrochloride; Serdexmethylphenidate Chloride |
Oral |
Capsule |
212994 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Dextromethorphan Hydrobromide; Quinidine Sulfate |
Oral |
Capsule |
021879 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Diazepam |
Oral |
Tablet |
013263 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Diazoxide |
Oral |
Suspension |
017453 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Dichlorphenamide |
Oral |
Tablet |
011366 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Diclofenac |
Oral |
Capsule |
204592 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Diclofenac Potassium |
Oral |
Tablet |
020142 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Diclofenac Potassium |
Oral |
Capsule |
022202 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Dicyclomine Hydrochloride |
Oral |
Capsule |
007409 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Dicyclomine Hydrochloride |
Oral |
Tablet |
007409 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Dienogest; Estradiol Valerate |
Oral |
Tablet |
022252 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Diflunisal |
Oral |
Tablet |
018445 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Diphenhydramine Citrate; Ibuprofen |
Oral |
Tablet |
021394 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Diphenhydramine Hydrochloride |
Oral |
Capsule |
080738 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Diphenhydramine Hydrochloride; Ibuprofen |
Oral |
Capsule |
021393 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Diphenhydramine Hydrochloride; Naproxen Sodium |
Oral |
Tablet |
205352 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Dipyridamole |
Oral |
Tablet |
012836 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Disopyramide Phosphate |
Oral |
Capsule |
017447 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Disulfiram |
Oral |
Tablet |
007883 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Dofetilide |
Oral |
Capsule |
020931 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Dolasetron Mesylate |
Oral |
Tablet |
020623 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Dolutegravir Sodium |
Oral |
Tablet |
204790 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Dolutegravir Sodium |
Oral |
Tablet, For Suspension |
213983 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Dolutegravir Sodium; Lamivudine |
Oral |
Tablet |
211994 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Dolutegravir Sodium; Rilpivirine Hydrochloride |
Oral |
Tablet |
210192 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Donepezil Hydrochloride |
Oral |
Tablet |
020690 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Donepezil Hydrochloride |
Oral |
Tablet, Orally Disintegrating |
021720 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Donepezil Hydrochloride |
Oral |
Tablet |
022568 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Doxazosin Mesylate |
Oral |
Tablet |
019668 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Doxepin Hydrochloride |
Oral |
Capsule |
016798 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Doxepin Hydrochloride |
Oral |
Tablet |
022036 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Doxycycline |
Oral |
Capsule |
050006 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Doxycycline |
Oral |
Capsule |
050641 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Doxycycline |
Oral |
Tablet |
065055 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Doxycycline |
Oral |
For Suspension |
065070 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Doxycycline Calcium |
Oral |
Suspension |
050480 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Doxycycline Hyclate |
Oral |
Capsule |
050007 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Doxycycline Hyclate |
Oral |
Tablet |
050533 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Doxycycline Hyclate |
Oral |
Tablet |
205931 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Doxycycline Hyclate |
Oral |
Capsule |
209844 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Doxycycline Hyclate |
Oral |
Tablet |
208253 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Dronedarone Hydrochloride |
Oral |
Tablet |
022425 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Drospirenone |
Oral |
Tablet |
211367 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Drospirenone; Estetrol |
Oral |
Tablet |
214154 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Drospirenone; Estradiol |
Oral |
Tablet |
021355 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Drospirenone; Ethinyl Estradiol |
Oral-28 |
Tablet |
021098 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Drospirenone; Ethinyl Estradiol |
Oral |
Tablet |
021676 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
02/2025 |
| Drospirenone; Ethinyl Estradiol; Levomefolate Calcium |
Oral |
Tablet |
022532; 022574 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
02/2025 |
| Droxidopa |
Oral |
Capsule |
203202 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Duvelisib |
Oral |
Capsule |
211155 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Elacestrant Dihydrochloride |
Oral |
Tablet |
217639 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Elagolix Sodium |
Tablet |
Oral |
210450 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Elagolix Sodium, Estradiol, Norethindrone Acetate; Elagolix Sodium |
Capsule |
Oral |
213388 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Eletriptan Hydrobromide |
Oral |
Tablet |
021016 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Eliglustat Tartrate |
Oral |
Capsule |
205494 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Eltrombopag Olamine |
Oral |
Tablet |
022291 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Eltrombopag Olamine |
Oral |
For Suspension |
207027 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Eluxadoline |
Oral |
Tablet |
206940 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Empagliflozin |
Oral |
Tablet |
204629 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Empagliflozin; Linagliptin |
Oral |
Tablet |
206073 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Empagliflozin; Metformin Hydrochloride |
Oral |
Tablet |
206111 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Emtricitabine |
Oral |
Capsule |
021500 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Emtricitabine; Rilpivirine Hydrochloride; Tenofovir Alafenamide Fumarate |
Oral |
Tablet |
208351 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Emtricitabine; Rilpivirine Hydrochloride; Tenofovir Disoproxil Fumarate |
Oral |
Tablet |
202123 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Emtricitabine; Tenofovir Alafenamide Fumarate |
Oral |
Tablet |
208215 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Emtricitabine; Tenofovir Disoproxil Fumarate |
Oral |
Tablet |
021752 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Enalapril Maleate |
Oral |
Tablet |
018998 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Enasidenib Mesylate |
Oral |
Tablet |
209606 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Entacapone |
Oral |
Tablet |
020796 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Eplerenone |
Oral |
Tablet |
021437 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Eprosartan Mesylate |
Oral |
Tablet |
020738 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
02/2025 |
| Eprosartan Mesylate; Hydrochlorothiazide |
Oral |
Tablet |
021268 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Erdafitinib |
Oral |
Tablet |
212018 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ertugliflozin |
Tablet |
Oral |
209803 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ertugliflozin; Metformin Hydrochloride |
Oral |
Tablet |
209806 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ertugliflozin; Sitagliptin Phosphate |
Oral |
Tablet |
209805 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Erythromycin Ethylsuccinate |
Oral |
Granule |
050207 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Erythromycin Ethylsuccinate |
Oral |
Tablet |
061904; 061905 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Erythromycin Ethylsuccinate; Sulfisoxazole Acetyl |
Oral |
Granule |
050529 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Escitalopram Oxalate |
Oral |
Capsule |
021323 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Escitalopram Oxalate |
Oral |
Tablet |
077660 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Eslicarbazepine Acetate |
Oral |
Tablet |
022416 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Estradiol |
Oral |
Tablet |
084499; 084500 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Estradiol; Norethindrone Acetate |
Oral |
Tablet |
020907 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Estrogens, Esterified |
Oral |
Tablet |
083266 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Eszopiclone |
Oral |
Tablet |
021476 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ethacrynic Acid |
Oral |
Tablet |
016092 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ethambutol Hydrochloride |
Oral |
Tablet |
016320 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ethinyl Estradiol; Ethynodiol Diacetate |
Oral-21 |
Tablet |
072723 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ethinyl Estradiol; Norethindrone Acetate |
Oral |
Tablet, Chewable |
204654 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ethinyl Estradiol; Levonorgestrel |
Oral-21 |
Tablet |
020683 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ethinyl Estradiol; Levonorgestrel |
Oral |
Tablet |
020860 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ethinyl Estradiol; Levonorgestrel |
Oral |
Tablet |
021864 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ethinyl Estradiol; Levonorgestrel |
Oral-21 |
Tablet |
208612 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ethinyl Estradiol; Levonorgestrel |
Oral-21 |
Tablet |
019190; 019192 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ethinyl Estradiol; Levonorgestrel |
Oral |
Tablet |
018782 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ethinyl Estradiol; Levonorgestrel |
Oral |
Tablet |
021544; 021840; 204061 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ethinyl Estradiol; Norethindrone |
Oral |
Tablet |
018977 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ethinyl Estradiol; Norethindrone |
Oral |
Tablet |
021490, 202086 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ethinyl Estradiol; Norethindrone |
Oral-28 |
Tablet, Chewable |
022573 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ethinyl Estradiol; Norethindrone |
Oral-28 |
Tablet |
017716; 200897; 203006 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ethinyl Estradiol; Norethindrone Acetate |
Oral |
Tablet |
017354; 017355; 021871 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ethinyl Estradiol; Norethindrone |
Oral-21 |
Tablet |
017735; 017919; 018985 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ethinyl Estradiol; Norethindrone Acetate |
Oral |
Tablet |
020130 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ethinyl Estradiol; Norethindrone Acetate |
Oral |
Tablet |
021065 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ethinyl Estradiol; Norethindrone Acetate |
Oral |
Tablet |
022501 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ethinyl Estradiol; Norethindrone Acetate |
Oral |
Tablet |
203667 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ethinyl Estradiol; Norgestimate |
Oral-21 |
Tablet |
019653; 019697; 021241 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ethinyl Estradiol; Norgestrel |
Oral-21 |
Tablet |
017612; 017802 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ethionamide |
Oral |
Tablet |
013026 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ethosuximide |
Oral |
Capsule |
012380 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Etodolac |
Oral |
Capsule |
018922 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Etodolac |
Oral |
Tablet |
018922 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Exemestane |
Oral |
Tablet |
020753 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ezetimibe |
Oral |
Tablet |
021445 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ezetimibe; Simvastatin |
Oral |
Tablet |
021687 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ezogabine |
Oral |
Tablet |
022345 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Famciclovir |
Oral |
Tablet |
020363 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Famotidine |
Oral |
For Suspension |
019527 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Famotidine |
Oral |
Tablet, Chewable |
020801 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Famotidine |
Oral |
Tablet |
019462; 020325 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Famotidine |
Oral |
Tablet, Orally Disintegrating |
020752; 021712 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Famotidine; Ibuprofen |
Oral |
Tablet |
022519 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Febuxostat |
Oral |
Tablet |
021856 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Fedratinib Hydrochloride |
Oral |
Capsule |
212327 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Fenofibric Acid |
Oral |
Tablet |
022418 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Fenoprofen Calcium |
Oral |
Capsule |
017604 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Fexofenadine Hydrochloride |
Oral |
Capsule |
020625 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Fexofenadine Hydrochloride |
Oral |
Tablet |
020872 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Fexofenadine Hydrochloride |
Oral |
Suspension |
021963 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Fexofenadine Hydrochloride |
Oral |
Suspension |
201373 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Finasteride |
Oral |
Tablet |
020180; 020788 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Finerenone |
Oral |
Tablet |
215341 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Fingolimod Hydrochloride |
Oral |
Capsule |
022527 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Fingolimod Lauryl Sulfate |
Oral |
Tablet, Orally Disintegrating |
214962 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Flavoxate Hydrochloride |
Oral |
Tablet |
016769 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Flecainide Acetate |
Oral |
Tablet |
018830 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Flibanserin |
Oral |
Tablet |
022526 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Fluconazole |
Oral |
Tablet |
019949 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Flucytosine |
Oral |
Capsule |
017001 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Fludrocortisone Acetate |
Oral |
Tablet |
010060 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Fluoxetine Hydrochloride |
Oral |
Capsule |
018936 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Fluoxetine Hydrochloride |
Oral |
Tablet |
020974 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Fluoxetine Hydrochloride |
Oral |
Tablet |
021860 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Fluoxetine Hydrochloride |
Oral |
Tablet |
202133 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Fluoxetine Hydrochloride; Olanzapine |
Oral |
Capsule |
021520 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Fluphenazine Hydrochloride |
Oral |
Tablet |
011751 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Flutamide |
Oral |
Capsule |
018554 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Fluvastatin Sodium |
Oral |
Capsule |
020261 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Fosamprenavir Calcium |
Oral |
Tablet |
021548 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Fosinopril Sodium |
Oral |
Tablet |
019915 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Fosinopril Sodium; Hydrochlorothiazide |
Oral |
Tablet |
020286 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Frovatriptan Succinate |
Oral |
Tablet |
021006 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Furosemide |
Oral |
Tablet |
016273 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Futibatinib |
Oral |
Tablet |
214801 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Gabapentin |
Oral |
Capsule |
020235 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Gabapentin |
Oral |
Tablet |
020882 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Galantamine Hydrobromide |
Oral |
Tablet |
021169 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ganaxolone |
Oral |
Suspension |
215904 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ganciclovir |
Oral |
Capsule |
020460 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Gefitinib |
Oral |
Tablet |
206995 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Gemifloxacin Mesylate |
Oral |
Tablet |
021158 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Gilteritinib Fumarate |
Oral |
Tablet |
211349 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Glasdegib Maleate |
Oral |
Tablet |
210656 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Glimepiride |
Oral |
Tablet |
020496 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Glimepiride; Pioglitazone Hydrochloride |
Oral |
Tablet |
021925 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Glimepiride; Rosiglitazone Maleate |
Oral |
Tablet |
021700 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Glipizide |
Oral |
Tablet |
017783 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Glipizide; Metformin Hydrochloride |
Oral |
Tablet |
021460 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Glyburide |
Oral |
Tablet |
020051 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Glyburide |
Oral |
Tablet |
017498; 017532 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Glyburide; Metformin Hydrochloride |
Oral |
Tablet |
021178 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Granisetron Hydrochloride |
Oral |
Tablet |
020305 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Griseofulvin, Microcrystalline |
Oral |
Tablet |
062279 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Guanfacine Hydrochloride |
Oral |
Tablet |
019032 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Haloperidol |
Oral |
Tablet |
015921 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Hydralazine Hydrochloride; Isosorbide Dinitrate |
Oral |
Tablet |
020727 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Hydrochlorothiazide |
Oral |
Tablet |
011835 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Hydrochlorothiazide |
Oral |
Capsule |
020504 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Hydrochlorothiazide; Irbesartan |
Oral |
Tablet |
020758 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Hydrochlorothiazide; Lisinopril |
Oral |
Tablet |
019778; 019888 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Hydrochlorothiazide; Losartan Potassium |
Oral |
Tablet |
020387 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Hydrochlorothiazide; Metoprolol Tartrate |
Oral |
Tablet |
018303 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Hydrochlorothiazide; Olmesartan Medoxomil |
Oral |
Tablet |
021532 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Hydrochlorothiazide; Quinapril Hydrochloride |
Oral |
Tablet |
020125 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Hydrochlorothiazide; Spironolactone |
Oral |
Tablet |
012616 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Hydrochlorothiazide; Triamterene |
Oral |
Capsule |
016042 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Hydrochlorothiazide; Triamterene |
Oral |
Tablet |
019129 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Hydrochlorothiazide; Valsartan |
Oral |
Tablet |
020818 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Hydrocodone Bitartrate; Ibuprofen |
Oral |
Tablet |
020716 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Hydrocortisone |
Oral |
Tablet |
008697 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Hydromorphone Hydrochloride |
Oral |
Tablet |
019892 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Hydroxychloroquine Sulfate |
Oral |
Tablet |
009768 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Hydroxyzine Pamoate |
Oral |
Capsule |
011459 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Hydroxyzine Pamoate |
Oral |
Suspension |
011795 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ibrexafungerp Citrate |
Oral |
Tablet |
214900 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ibrutinib |
Oral |
Capsule |
205552 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ibrutinib |
Oral |
Tablet |
210563 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ibuprofen |
Oral |
Tablet |
017463 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ibuprofen |
Oral |
Tablet |
019012 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ibuprofen |
Oral |
Suspension |
019842 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ibuprofen |
Oral |
Capsule |
020402 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ibuprofen |
Oral |
Suspension |
020516 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ibuprofen |
Oral |
Tablet, Chewable |
020601 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ibuprofen |
Oral |
Suspension/Drops |
020812 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ibuprofen |
Oral |
Capsule |
021472 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ibuprofen Sodium |
Oral |
Tablet |
201803 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ibuprofen; Phenylephrine Hydrochloride |
Oral |
Tablet |
022565 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ibuprofen; Pseudoephedrine Hydrochloride |
Oral |
Tablet |
019771 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ibuprofen; Pseudoephedrine Hydrochloride |
Oral |
Suspension |
021128 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ibuprofen; Pseudoephedrine Hydrochloride |
Oral |
Capsule |
021374 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Icosapent Ethyl |
Oral |
Capsule |
202057 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Complex |
10/2024 |
| Idelalisib |
Oral |
Tablet |
205858 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Iloperidone |
Oral |
Tablet |
022192 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Imipramine Pamoate |
Oral |
Capsule |
017090 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Indapamide |
Oral |
Tablet |
018538 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Indinavir Sulfate |
Oral |
Capsule |
020685 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Indomethacin |
Oral |
Capsule |
016059 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Indomethacin |
Oral |
Suspension |
018332 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Indomethacin |
Oral |
Capsule |
204768 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Irbesartan |
Oral |
Tablet |
020757 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Isavuconazonium Sulfate |
Oral |
Capsule |
207500 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Isocarboxazid |
Oral |
Tablet |
011961 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Isosorbide Dinitrate |
Oral |
Tablet |
012093 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Isosorbide Dinitrate |
Oral |
Tablet |
087946 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Isradipine |
Oral |
Capsule |
019546 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Istradefylline |
Oral |
Tablet |
022075 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ivabradine Hydrochloride |
Oral |
Tablet |
206143 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ketoconazole |
Oral |
Tablet |
018533 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ketoprofen |
Oral |
Capsule |
018754 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ketorolac Tromethamine |
Oral |
Tablet |
019645 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Lacosamide |
Oral |
Tablet |
022253 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Lamivudine |
Oral |
Tablet |
020564 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Lamivudine |
Oral |
Tablet |
021003 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Lamivudine; Tenofovir Disoproxil Fumarate |
Oral |
Tablet |
022141 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Lamivudine; Tenofovir Disoproxil Fumarate |
Oral |
Tablet |
022344 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Lamivudine; Tenofovir Disoproxil Fumarate |
Oral |
Tablet |
211284 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Lamivudine; Zidovudine |
Oral |
Tablet |
020857 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Lamotrigine |
Oral |
Tablet |
020241 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Lamotrigine |
Oral |
Tablet, Chewable |
020764 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Lamotrigine |
Oral |
Tablet, Orally Disintegrating |
022251 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Larotrectinib Sulfate |
Oral |
Capsule |
210861 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Lasmiditan Succinate |
Oral |
Tablet |
211280 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Leflunomide |
Oral |
Tablet |
020905 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Lemborexant |
Oral |
Tablet |
212028 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Lenalidomide |
Oral |
Capsule |
021880 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Lesinurad |
Oral |
Tablet |
207988 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Letermovir |
Oral |
Tablet |
209939 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Letrozole |
Oral |
Tablet |
020726 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Letrozole; Ribociclib Succinate |
Oral |
Tablet, Tablet |
209935 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Leucovorin Calcium |
Oral |
Tablet |
018342 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Levetiracetam |
Oral |
Tablet |
021035 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Levetiracetam |
Oral |
Tablet, For Suspension |
207958 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Levocarnitine |
Oral |
Tablet |
018948 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Levocetirizine Dihydrochloride |
Oral |
Tablet |
022064 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Levocetirizine Dihydrochloride |
Oral |
Tablet |
209089 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Levofloxacin |
Oral |
Tablet |
020634 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Levonorgestrel |
Oral |
Tablet |
021045; 021998 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Levorphanol Tartrate |
Oral |
Tablet |
008720 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Linagliptin |
Oral |
Tablet |
201280 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Linagliptin; Metformin Hydrochloride |
Oral |
Tablet |
201281 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Linezolid |
Oral |
Tablet |
021130 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Linezolid |
Oral |
For Suspension |
021132 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Lisdexamfetamine Dimesylate |
Oral |
Capsule |
021977 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Lisdexamfetamine Dimesylate |
Oral |
Tablet, Chewable |
208510 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Lisinopril |
Oral |
Tablet |
019777 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Lofexidine Hydrochloride |
Oral |
Tablet |
209229 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Loperamide Hydrochloride |
Oral |
Capsule |
017694 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Loperamide Hydrochloride |
Oral |
Suspension |
019487 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Loperamide Hydrochloride |
Oral |
Tablet |
019860 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Loperamide Hydrochloride |
Oral |
Tablet, Chewable |
020448 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Loperamide Hydrochloride |
Oral |
Capsule |
021855 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Loperamide Hydrochloride; Simethicone |
Oral |
Tablet, Chewable |
020606 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Loratadine |
Oral |
Tablet |
019658 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Loratadine |
Oral |
Tablet, Orally Disintegrating |
020704 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Loratadine |
Oral |
Tablet, Chewable |
021891 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Loratadine |
Capsule |
Oral |
21952 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Lorazepam |
Oral |
Tablet |
017794 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Losartan Potassium |
Tablet |
Oral |
020386 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Lumateperone Tosylate |
Oral |
Capsule |
209500 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Lurasidone Hydrochloride |
Oral |
Tablet |
200603 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
02/2025 |
| Lusutrombopag |
Oral |
Tablet |
210923 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Macitentan |
Oral |
Tablet |
204410 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
11/2024 |
| Maraviroc |
Oral |
Tablet |
022128 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Maribavir |
Oral |
Tablet |
215596 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Mavacamten |
Oral |
Capsule |
214998 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Mecamylamine Hydrochloride |
Oral |
Tablet |
010251 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Medroxyprogesterone Acetate |
Oral |
Tablet |
011839 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Mefenamic Acid |
Oral |
Capsule |
015034 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Megestrol Acetate |
Oral |
Suspension |
020264 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Meloxicam |
Oral |
Tablet |
020938 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Meloxicam |
Oral |
Suspension |
021530 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Meloxicam |
Oral |
Capsule |
207233 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Meloxicam |
Oral |
Tablet, Orally Disintegrating |
211210 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Memantine Hydrochloride |
Oral |
Tablet |
021487 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Mesna |
Oral |
Tablet |
020855 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Mestranol; Norethindrone |
Oral-28 |
Tablet |
016659 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Metformin Hydrochloride |
Oral |
Tablet |
020357 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Metformin Hydrochloride; Pioglitazone Hydrochloride |
Oral |
Tablet |
021842 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Metformin Hydrochloride; Repaglinide |
Oral |
Tablet |
022386 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Metformin Hydrochloride; Sitagliptin Phosphate |
Oral |
Tablet |
022044 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Methazolamide |
Oral |
Tablet |
011721 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Methenamine Hippurate |
Oral |
Tablet |
017681 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Methimazole |
Oral |
Tablet |
007517 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Methoxsalen |
Oral |
Capsule |
009048 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Methoxsalen |
Oral |
Capsule |
019600 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Methsuximide |
Oral |
Capsule |
010596 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Methylergonovine Maleate |
Oral |
Tablet |
006035 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Methylphenidate Hydrochloride |
Oral |
Tablet |
010187 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Methylphenidate Hydrochloride |
Oral |
Tablet, Chewable |
021475 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Methylprednisolone |
Oral |
Tablet |
011153 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Methyltestosterone |
Oral |
Capsule |
083976 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Metoclopramide Hydrochloride |
Oral |
Tablet |
017854 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Metoclopramide Hydrochloride |
Oral |
Tablet, Orally Disintegrating |
022246 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Metolazone |
Oral |
Tablet |
017386 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Metoprolol Tartrate |
Oral |
Tablet |
017963 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Metyrosine |
Oral |
Capsule |
017871 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Mexiletine Hydrochloride |
Oral |
Capsule |
018873 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Midodrine Hydrochloride |
Oral |
Tablet |
019815 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Miglustat |
Oral |
Capsule |
021348 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Milnacipran Hydrochloride |
Oral |
Tablet |
022256 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Minocycline Hydrochloride |
Oral |
Tablet |
050451 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Minocycline Hydrochloride |
Oral |
Capsule |
050649 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Minoxidil |
Oral |
Tablet |
018154 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Mirtazapine |
Oral |
Tablet |
020415 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Mirtazapine |
Oral |
Tablet, Orally Disintegrating |
021208 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Mitapivat Sulfate |
Oral |
Tablet |
216196 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Modafinil |
Oral |
Tablet |
020717 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Molindone Hydrochloride |
Oral |
Tablet |
017111 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Montelukast Sodium |
Oral |
Tablet |
020829 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Montelukast Sodium |
Oral |
Tablet, Chewable |
020830 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Montelukast Sodium |
Oral |
Granule |
021409 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Morphine Sulfate |
Oral |
Tablet |
022207 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Moxidectin |
Oral |
Tablet |
210867 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Moxifloxacin Hydrochloride |
Oral |
Tablet |
021085 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Mycophenolate Mofetil |
Oral |
Capsule |
050722 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Mycophenolate Mofetil |
Oral |
Tablet |
050723 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Mycophenolate Mofetil |
Oral |
Suspension |
050759 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Nabumetone |
Oral |
Tablet |
019583 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Nadolol |
Oral |
Tablet |
018063 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Naldemedine Tosylate |
Oral |
Tablet |
208854 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Naltrexone Hydrochloride |
Oral |
Tablet |
018932 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Naproxen |
Oral |
Tablet |
017581 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Naproxen |
Oral |
Suspension |
018965 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Naproxen Sodium |
Oral |
Tablet |
018164 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Naproxen Sodium |
Oral |
Tablet |
020204 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Naproxen Sodium |
Oral |
Capsule |
021920 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Naratriptan Hydrochloride |
Oral |
Tablet |
020763 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Nateglinide |
Oral |
Tablet |
021204 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Nebivolol Hydrochloride |
Oral |
Tablet |
021742 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Nebivolol Hydrochloride; Valsartan |
Oral |
Tablet |
206302 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Neratinib Maleate |
Oral |
Tablet |
208051 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Netupitant; Palonosetron Hydrochloride |
Oral |
Capsule |
205718 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Nevirapine |
Oral |
Tablet |
020636 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Nevirapine |
Oral |
Suspension |
020933 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Nicardipine Hydrochloride |
Oral |
Capsule |
019488 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Nimodipine |
Oral |
Capsule |
018869 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Nitisinone |
Oral |
Suspension |
206356 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Nitisinone |
Oral |
Tablet |
209449 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Nitrofurantoin |
Oral |
Suspension |
009175 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Nitrofurantoin, Macrocrystalline |
Oral |
Capsule |
016620 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Nitrofurantoin; Nitrofurantoin, Macrocrystalline |
Oral |
Capsule |
020064 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Norethindrone |
Oral-28 |
Tablet |
016954 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Norethindrone |
Oral-28 |
Tablet |
017060 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Norethindrone Acetate |
Oral |
Tablet |
018405 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Nortriptyline Hydrochloride |
Oral |
Capsule |
018013 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Obeticholic Acid |
Oral |
Tablet |
207999 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Olanzapine |
Oral |
Tablet |
020592 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Olanzapine |
Oral |
Tablet, Orally Disintegrating |
021086 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Olanzapine; Samidorphan L-Malate |
Oral |
Tablet |
213378 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Olmesartan Medoxomil |
Oral |
Tablet |
021286 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Omaveloxolone |
Oral |
Capsule |
216718 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Omega-3-Acid Ethyl Esters Type A |
Oral |
Capsule |
204977 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Complex |
10/2024 |
| Ondansetron |
Oral |
Tablet, Orally Disintegrating |
020781 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ondansetron Hydrochloride |
Oral |
Tablet |
020103 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Oseltamivir Phosphate |
Oral |
Capsule |
021087 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Oseltamivir Phosphate |
Oral |
For Suspension |
021246 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Osilodrostat Phosphate |
Oral |
Tablet |
212801 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Osimertinib Mesylate |
Oral |
Tablet |
208065 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ospemifene |
Oral |
Tablet |
203505 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Oteseconazole |
Oral |
Capsule |
215888 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Oxaprozin |
Oral |
Tablet |
018841 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Oxazepam |
Oral |
Capsule |
015539 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Oxcarbazepine |
Oral |
Tablet |
021014 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Oxcarbazepine |
Oral |
Suspension |
021285 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Oxybutynin Chloride |
Oral |
Tablet |
017577 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Oxycodone Hydrochloride |
Oral |
Tablet |
021011 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Oxycodone Hydrochloride |
Oral |
Capsule |
200534 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Oxymetholone |
Oral |
Tablet |
016848 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ozanimod Hydrochloride |
Oral |
Capsule |
209899 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Pacritinib Citrate |
Oral |
Capsule |
208712 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Palbociclib |
Oral |
Capsule |
207103 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Palonosetron Hydrochloride |
Oral |
Capsule |
022233 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Panobinostat Lactate |
Oral |
Capsule |
205353 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Paroxetine Hydrochloride |
Oral |
Tablet |
020031 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Paroxetine Mesylate |
Oral |
Tablet |
021299 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Paroxetine Mesylate |
Oral |
Capsule |
204516 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Pemigatinib |
Oral |
Tablet |
213736 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Penbutolol Sulfate |
Oral |
Tablet |
018976 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Penicillin V Potassium |
Oral |
Tablet |
065435 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Perampanel |
Oral |
Tablet |
202834 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Perampanel |
Oral |
Suspension |
208277 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Perindopril Erbumine |
Oral |
Tablet |
020184 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Perphenazine |
Oral |
Tablet |
010775 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Phenelzine Sulfate |
Oral |
Tablet |
011909 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Phentermine Hydrochloride |
Oral |
Tablet, Orally Disintegrating |
202088 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Pilocarpine Hydrochloride |
Oral |
Tablet |
020237 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Pimavanserin Tartrate |
Oral |
Tablet |
207318 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A; Add a BCS-based biowaiver option |
Non-Complex |
10/2024 |
| Pimavanserin Tartrate |
Oral |
Capsule |
210793 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A; Add a BCS-based biowaiver option |
Non-Complex |
10/2024 |
| Pimozide |
Oral |
Tablet |
017473 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Pindolol |
Oral |
Tablet |
018285 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Pioglitazone Hydrochloride |
Oral |
Tablet |
021073 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Pirfenidone |
Oral |
Capsule |
022535 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Pirfenidone |
Oral |
Tablet |
208780 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Piroxicam |
Oral |
Capsule |
018147 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Pitavastatin Calcium |
Oral |
Tablet |
022363 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Pitavastatin Magnesium |
Oral |
Tablet |
208379 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Pitavastatin Sodium |
Oral |
Tablet |
209875 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Pitolisant Hydrochloride |
Oral |
Tablet |
211150 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Pomalidomide |
Oral |
Capsule |
204026 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ponesimod |
Oral |
Tablet |
213498 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Pramipexole Dihydrochloride |
Oral |
Tablet |
020667 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Prasugrel Hydrochloride |
Oral |
Tablet |
022307 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Pravastatin Sodium |
Oral |
Tablet |
019898 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Praziquantel |
Oral |
Tablet |
018714 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Prazosin Hydrochloride |
Oral |
Capsule |
017442 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Prednisolone |
Oral |
Tablet |
080354 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Prednisolone Acetate |
Oral |
Suspension |
022067 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Prednisolone Sodium Phosphate |
Oral |
Tablet, Orally Disintegrating |
021959 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Pregabalin |
Oral |
Capsule |
021446 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Primaquine Phosphate |
Oral |
Tablet |
008316 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Primidone |
Tablet |
Oral |
009170 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Prochlorperazine Maleate |
Oral |
Tablet |
010571 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Promethazine Hydrochloride |
Oral |
Tablet |
007935 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Propafenone Hydrochloride |
Oral |
Tablet |
019151 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Propranolol Hydrochloride |
Oral |
Tablet |
016418 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Propylthiouracil |
Oral |
Tablet |
006188 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Protriptyline Hydrochloride |
Oral |
Tablet |
016012 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Prucalopride Succinate |
Oral |
Tablet |
210166 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
11/2024 |
| Pyrazinamide |
Oral |
Tablet |
080157 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Pyridostigmine Bromide |
Oral |
Tablet |
009829 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Pyrimethamine |
Oral |
Tablet |
008578 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Quetiapine Fumarate |
Oral |
Tablet |
020639 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Quinapril Hydrochloride |
Oral |
Tablet |
019885 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Raloxifene Hydrochloride |
Oral |
Tablet |
020815 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ramelteon |
Oral |
Tablet |
021782 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ramipril |
Oral |
Capsule |
019901 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ramipril |
Oral |
Tablet |
022021 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ranitidine Hydrochloride |
Oral |
Tablet |
018703 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ranitidine Hydrochloride |
Oral |
Capsule |
020095 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ranitidine Hydrochloride |
Oral |
Tablet, Effervescent |
020745 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ranitidine Hydrochloride |
Oral |
Tablet |
020520; 021698 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Rasagiline Mesylate |
Tablet |
Oral |
021641 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Relugolix |
Oral |
Tablet |
214621 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Repaglinide |
Oral |
Tablet |
020741 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Reserpine |
Oral |
Tablet |
009838 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ribavirin |
Oral |
Capsule |
020903 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ribavirin |
Oral |
Tablet |
021511 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ribociclib Succinate |
Oral |
Tablet |
209092 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Rifapentine |
Oral |
Tablet |
021024 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Rilpivirine Hydrochloride |
Oral |
Tablet |
202022 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Rimegepant Sulfate |
Oral |
Tablet, Orally Disintegrating |
212728 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
11/2024 |
| Riociguat |
Oral |
Tablet |
204819 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Risperidone |
Oral |
Tablet |
020272 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Risperidone |
Oral |
Tablet, Orally Disintegrating |
021444 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Rivastigmine Tartrate |
Oral |
Capsule |
020823 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Rizatriptan Benzoate |
Oral |
Tablet |
020864 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Rizatriptan Benzoate |
Oral |
Tablet, Orally Disintegrating |
020865 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Roflumilast |
Oral |
Tablet |
022522 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Rolapitant Hydrochloride |
Oral |
Tablet |
206500 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ropinirole Hydrochloride |
Oral |
Tablet |
020658 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Rosiglitazone Maleate |
Oral |
Tablet |
021071 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Rosuvastatin Calcium |
Oral |
Tablet |
021366 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Rufinamide |
Oral |
Tablet |
021911 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Rufinamide |
Oral |
Suspension |
201367 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ruxolitinib Phosphate |
Oral |
Tablet |
202192 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Sacubitril; Valsartan |
Oral |
Tablet |
207620 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Safinamide Mesylate |
Oral |
Tablet |
207145 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Sapropterin Dihydrochloride |
Oral |
Tablet |
022181 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Sarecycline Hydrochloride |
Oral |
Tablet |
209521 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Saxagliptin Hydrochloride |
Oral |
Tablet |
022350 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Selegiline Hydrochloride |
Oral |
Tablet, Orally Disintegrating |
020647 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Selegiline Hydrochloride |
Oral |
Capsule |
021479 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Selexipag |
Oral |
Tablet |
207947 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Selpercatinib |
Oral |
Capsule |
213246 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Sertraline Hydrochloride |
Oral |
Tablet |
019839 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Sertraline Hydrochloride |
Oral |
Capsule |
215133 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Sibutramine Hydrochloride |
Oral |
Capsule |
020632 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Sildenafil Citrate |
Oral |
For Suspension |
203109 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Sildenafil Citrate |
Oral |
Tablet |
020895; 021845 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Silodosin |
Oral |
Capsule |
022206 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Simvastatin |
Oral |
Tablet |
019766 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Simvastatin |
Oral |
Tablet, Orally Disintegrating |
021961 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Simvastatin; Sitagliptin Phosphate |
Oral |
Tablet |
202343 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Siponimod Fumaric Acid |
Oral |
Tablet |
209884 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Sitagliptin Phosphate |
Oral |
Tablet |
021995 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Sodium Phenylbutyrate |
Oral |
Tablet |
020572 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Sodium Phenylbutyrate |
Oral |
Powder |
020573 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Sodium Phenylbutyrate; Taurursodiol |
Oral |
For Suspension |
216660 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Sofosbuvir |
Oral |
Tablet |
204671 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Solifenacin Succinate |
Oral |
Tablet |
021518 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Solriamfetol Hydrochloride |
Oral |
Tablet |
211230 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Sotalol Hydrochloride |
Oral |
Tablet |
019865 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Sotalol Hydrochloride |
Oral |
Tablet |
021151 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Sotorasib |
Oral |
Tablet |
214665 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Sparsentan |
Oral |
Tablet |
216403 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Spironolactone |
Oral |
Tablet |
012151 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Spironolactone |
Oral |
Suspension |
209478 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Stavudine |
Oral |
Capsule |
020412 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Stiripentol |
Oral |
Capsule |
206709 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Stiripentol |
Oral |
For Suspension |
207223 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Succimer |
Oral |
Capsule |
019998 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Sulfadiazine |
Oral |
Tablet |
004122 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Sulfamethoxazole; Trimethoprim |
Oral |
Tablet |
017377 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Sulfamethoxazole; Trimethoprim |
Oral |
Suspension |
017560 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Sumatriptan Succinate |
Oral |
Tablet |
020132 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Tadalafil |
Oral |
Tablet |
021368; 022332 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Tafenoquine Succinate |
Oral |
Tablet |
210607 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Tafenoquine Succinate |
Oral |
Tablet |
210795 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Tamoxifen Citrate |
Oral |
Tablet |
017970 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Tapentadol Hydrochloride |
Oral |
Tablet |
022304 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Tasimelteon |
Oral |
Suspension |
214517 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Tecovirimat |
Oral |
Capsule |
208627 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Tedizolid Phosphate |
Oral |
Tablet |
205435 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Telbivudine |
Oral |
Tablet |
022011 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Telithromycin |
Oral |
Tablet |
021144 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Telotristat Etiprate |
Oral |
Tablet |
208794 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Temazepam |
Oral |
Capsule |
018163 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Tenofovir Alafenamide Fumarate |
Oral |
Tablet |
208464 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Tenofovir Disoproxil Fumarate |
Oral |
Tablet |
021356 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Tenofovir Disoproxil Fumarate |
Oral |
Powder |
022577 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Tepotinib Hydrochloride |
Oral |
Tablet |
214096 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Terazosin Hydrochloride |
Oral |
Capsule |
020347 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Terbinafine Hydrochloride |
Oral |
Tablet |
020539 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Terbinafine Hydrochloride |
Oral |
Granule |
022071 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Terbutaline Sulfate |
Oral |
Tablet |
017849 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Teriflunomide |
Oral |
Tablet |
202992 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Testosterone Undecanoate |
Oral |
Capsule |
213953 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Tetrabenazine |
Oral |
Tablet |
021894 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Tetracycline Hydrochloride |
Oral |
Capsule |
050278 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Thalidomide |
Capsule |
Oral |
20785 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Thioridazine Hydrochloride |
Oral |
Tablet |
011808 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Thiothixene |
Oral |
Capsule |
016584 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Tiagabine Hydrochloride |
Oral |
Tablet |
020646 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ticagrelor |
Oral |
Tablet |
022433 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ticlopidine Hydrochloride |
Oral |
Tablet |
019979 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Timolol Maleate |
Oral |
Tablet |
018017 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Tivozanib Hydrochloride |
Oral |
Capsule |
212904 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Tizanidine Hydrochloride |
Oral |
Tablet |
020397 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Tizanidine Hydrochloride |
Capsule |
Oral |
21447 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Tofacitinib Citrate |
Oral |
Tablet |
203214 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Tolcapone |
Oral |
Tablet |
020697 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
02/2025 |
| Tolterodine Tartrate |
Oral |
Tablet |
020771 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Topiramate |
Oral |
Tablet |
020505 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Topiramate |
Oral |
Capsule |
020844 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Toremifene Citrate |
Oral |
Tablet |
020497 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Torsemide |
Oral |
Tablet |
020136 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Torsemide |
Oral |
Tablet |
213218 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Trandolapril |
Oral |
Tablet |
020528 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Tranylcypromine Sulfate |
Oral |
Tablet |
012342 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Trazodone Hydrochloride |
Oral |
Tablet |
018207 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
02/2025 |
| Triamterene |
Oral |
Capsule |
013174 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Triazolam |
Oral |
Tablet |
017892 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Triclabendazole |
Oral |
Tablet |
208711 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Trimethoprim |
Oral |
Tablet |
018679 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Trimipramine Maleate |
Oral |
Capsule |
016792 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ubrogepant |
Oral |
Tablet |
211765 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ulipristal Acetate |
Oral |
Tablet |
022474 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Uridine Triacetate |
Oral |
Granule |
208159; 208169 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ursodiol |
Oral |
Capsule |
019594 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ursodiol |
Oral |
Tablet |
020675 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Valacyclovir Hydrochloride |
Oral |
Tablet |
020487 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Valbenazine Tosylate |
Oral |
Capsule |
209241 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Valganciclovir Hydrochloride |
Oral |
Tablet |
021304 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Valsartan |
Oral |
Tablet |
021283 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Vandetanib |
Oral |
Tablet |
022405 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Vardenafil Hydrochloride |
Oral |
Tablet, Orally Disintegrating |
021400 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Vardenafil Hydrochloride |
Oral |
Tablet |
200179 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Varenicline Tartrate |
Oral |
Tablet |
021928 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Verapamil Hydrochloride |
Tablet |
Oral |
018593; 018817 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Vericiguat |
Oral |
Tablet |
214377 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Vibegron |
Oral |
Tablet |
213006 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Vilazodone Hydrochloride |
Oral |
Tablet |
022567 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Vismodegib |
Oral |
Capsule |
203388 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Vorapaxar Sulfate |
Oral |
Tablet |
204886 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Vortioxetine Hydrobromide |
Oral |
Tablet |
204447 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Voxelotor |
Oral |
Tablet |
213137 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Voxelotor |
Oral |
Tablet, For Suspension |
216157 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Zalcitabine |
Oral |
Tablet |
020199 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Zaleplon |
Oral |
Capsule |
020859 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Zidovudine |
Oral |
Capsule |
019655 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Zidovudine |
Oral |
Tablet |
020518 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
02/2025 |
| Zileuton |
Oral |
Tablet |
020471 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ziprasidone Hydrochloride |
Oral |
Capsule |
020825 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Ziprasidone Hydrochloride |
Oral |
Suspension |
021483 |
Minor Revision: Remove recommendations on fasting BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Zolmitriptan |
Oral |
Tablet |
020768 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Zolmitriptan |
Oral |
Tablet, Orally Disintegrating |
021231 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Zolpidem Tartrate |
Oral |
Tablet |
019908 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
| Zonisamide |
Oral |
Capsule |
020789 |
Minor Revision: Remove recommendations on fed BE study to align with ICH M13A |
Non-Complex |
10/2024 |
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