Upcoming Product-Specific Guidances for Generic Drug Product

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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