Competitive Generic Therapy Approvals

322 Gocovri, NDA 208944 214897 Zydus Worldwide DMCC Amantidine Extended-release Capsules, 68.5 mg 8/26/2024 No N/A N/A 321 Advil Dual Action with Acetaminophen, NDA 211733 218247 Dr. Reddy’s Laboratories Limited Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC) 8/23/2024 No N/A N/A 320 Asacol HD, NDA 21830 213191 Teva Pharmaceuticals Inc. Mesalamine Delayed-release Tablets USP, 800 mg 8/22/2024 Deferred   8/22/2024 319 Lucemyra, NDA 209229 218613 Indoco Remedies Limited Lofexidine Tablets, 0.18 mg 8/20/2024 Yes N/A 8/28/2024 318 Ingrezza, NDA 209241 216137 Zydus Worldwide DMCC Valbenazine Capsules, 40 mg, 60 mg and 80 mg 8/7/2024 No N/A N/A 317 Pred Forte, NDA 17011 216935 Lupin Limited Prednisolone Acetate Ophthalmic Suspension USP, 1% 8/2/2024 Yes     316 Carafate Oral Suspension, NDA 19183 212769 Hikma Pharmaceuticals USA Inc. Sucralfate Oral Suspension, 1 g/10 mL 7/23/2024 No N/A N/A 315 Thiola EC, NDA 211843 216456 Teva Pharmaceuticals Inc. Tiopronin Delayed-Release Tablets, 100 mg and 300 mg 7/22/2024 No N/A N/A 314 Halaven, NDA 201532 214850 Long Grove Pharmaceuticals LLC Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL) Single-dose Vials 7/18/2024 No N/A N/A 313 Zinc Sulfate, NDA 209377 216135 Somerset Therapeutics LLC Zinc Sulfate Injection USP, 30 mg/10 mL (3 mg/mL) and 25 mg/5 mL (5 mg/mL) Pharmacy Bulk Package 7/17/2024 No N/A N/A 312 Tazorac, NDA 21184 217075 Padagis Israel Pharmaceuticals Ltd. Tazarotene Cream, 0.05% 7/15/2024 Yes N/A N/A 311 Divigel, NDA 022038 216055 Amneal Pharmaceuticals LLC Estradiol Gel, 0.1% (0.25 mg, 0.5 mg, 0.75 mg, 1 mg, and 1.25 mg per Packet) 7/12/2024 No N/A N/A 310 Potassium Phosphates, NDA 212832 217726 Somerset Therapeutics LLC Potassium Phosphates Injection USP, Phosphorus 15 mmol/5 mL (3 mmol/mL) and Potassium 22 mEq/5 mL (4.4 mEq/mL), Phosphorous 45 mmol/15 mL (3 mmol/mL) and Potassium 66 mEq/15 mL (4.4 mEq/mL) in Single-Dose Vials 7/11/2024 No N/A N/A 309 Alrex, NDA 20803 215203 Padagis US LLC Loteprednol Etabonate Ophthalmic Suspension, 0.2% 7/10/2024 No N/A   308 Endari, NDA 208587 215647 Novitium Pharma LLC L-Glutamine Oral Powder, 5 grams/packet 7/8/2024 No N/A N/A 307 Zinc Sulfate, NDA 209377 214597 Nivagen Pharmaceuticals, Inc Zinc Sulfate Injection USP, 30 mg/10 mL (3 mg/mL), 25 mg/5 mL (5 mg/mL) and 10 mg/10 mL (1 mg/mL) Pharmacy Bulk Package 7/5/2024 No N/A N/A 306 Atropine Sulfate, NDA 214652 215969 Somerset Therapeutics LLC Atropine Sulfate Injection USP, 0.4 mg/mL and 1 mg/mL Single-Dose Vials 7/3/2024 No N/A N/A 305 Exparel, NDA 22496 214348 Jiangsu Hengrui Pharmaceuticals Co., Ltd. Bupivacaine Liposome Injectable Suspension, 133 mg/10 mL (13.3 mg/mL) and 266 mg/20 mL (13.3 mg/mL) Single -dose Vials 7/1/2024 No N/A N/A 304 Atropine Sulfate, NDA 206289 215618 Somerset Therapeutics LLC Atropine Sulfate Ophthalmic Solution USP, 1% 7/1/2024 No N/A N/A 303 Astepro OTC, NDA 213872 216576 ANDA Applicant Azelastine Hydrochloride Nasal Spray, 0.15% (205.5 mcg per spray)(OTC/Allergy) 6/5/2024 No N/A N/A 302 Astepro OTC, NDA 213872 216421 Apotex Inc. Azelastine Hydrochloride Nasal Spray, 0.15% (205.5 mcg per spray)(OTC/Allergy and Children’s Allergy) 5/29/2024 No N/A N/A 301 Halog, 17823 217671 Encube Ethicals Private Limited Halcinonide Topical Solution USP, 0.1% 5/29/2024 Yes Yes N/A 300 Phenylephrine, NDA 207926 215183 Caplin Steriles Limited Phenylephrine Hydrochloride Ophthalmic Solution USP, 2.5% and 10% 5/23/2024 No N/A N/A 299 Timolol Maleate, NDA 20963 216343 Amneal EU, Limited Timolol Maleate Ophthalmic Gel Forming Solution, 0.25% and 0.5% 5/23/2024 Yes Yes N/A 298 Somatuline Depot, NDA 22074 217193 InvaGen Pharmaceuticals, Inc. Lanreotide Injection, 60 mg/0.2 mL, 90 mg/0.3 mL, 120 mg/0.5 mL, Single-Dose Prefilled Syringes 5/21/2024 No N/A N/A 297 ProAir HFA, NDA 21457 212447 Armstrong Pharmaceuticals Inc. Albuterol Sulfate Inhalation Aerosol, 90 mcg (base) per actuation 5/21/2024 No N/A N/A 296 Calcium Gluconate in Sodium Chloride, NDA 208418 216611 Amneal EU, Limited Calcium Gluconate Injection USP, 1,000 mg/10 mL (100 mg/mL) Single-Dose Vials (10 mL Fill) and Calcium Glconate Injection USP, 5,000 mg/50 mL (100 mg/mL) Single-Dose Vials (50 mL Fill) 5/10/2024 No N/A N/A 295 Zegerid OTC, NDA 22283 217784 Dr. Reddy’s Laboratories Limited Omeprazole and Sodium Bicarbonate Powder for Oral Suspension, 20 mg/1680 mg (OTC) 5/9/2024 Yes Yes N/A 294 Dexamethasone, NDA 88306 216284 Zydus Pharmaceuticals (USA) Inc. Dexamethasone Tablets USP, 1 mg 5/9/2024 No N/A N/A 293 Vasostrict, NDA 204485 213988 Dr. Reddy’s Laboratories Limited Vasopressin Injection USP, 20 Units/mL Single-Dose Vials 5/8/2024 No N/A N/A 292 Radicava, NDA 209176 218354 Long Grove Pharmaceuticals LLC Edaravone Injection, 30 mg/100 ml (0.3 mg/mL), Single-Dose Bag 5/6/2024 No N/A N/A 291 Radicava, NDA 209176 215917 Dr. Reddy’s Laboratories Limited   Edaravone Injection, 60 mg/100 ml (0.6 mg/mL), Single-Dose Bag 5/6/2024 No N/A N/A 290 Cupric Chloride in Plastic Container, NDA 18960 217626 Stira Pharmaceuticals LLC Cupric Chloride Injection USP, 4 mg/10 mL (0.4 mg/mL) Single-Dose Vials 4/30/2024 Yes N/A N/A 289 Cupric Chloride in Plastic Container, NDA 18960 216113 Somerset Therapeutics Cupric Chloride Injection USP, 4 mg/10 mL (0.4 mg/mL) Single-Dose Vials 4/30/2024 Yes N/A 6/24/2024 288 Isopto Atropine, NDA 208151 217791 Somerset Therapeutics Atropine Sulfate Ophthalmic Solution USP, 1 4/29/2024 Yes No 6/7/2024 287 Nasonex, NDA 215712 217438 Apotex Inc.   Mometasone Furoate Nasal Spray, 50 mcg/spray (OTC)   4/23/2024 No N/A N/A 286 Votrient, NDA 22465 218231 Novugen Oncology Sdn. Bhd. Pazopanib Tablets, 200 mg 4/23/2024 No N/A N/A 285 EstroGel, NDA 21166 216160 Solaris Pharma Corporation Estradiol Gel, 0.06% 4/22/2024 Yes No 4/26/2024 284 Tranexamic Acid, NDA 212020 216877 Nexus Pharmaceuticals LLC Tranexamic Acid in 0.7% Sodium Chloride Injection, 1,000 mg/100 mL (10 mg/mL) 4/16/2024 No N/A N/A 283 Miacalcin, NDA 017808 215715 Dr. Reddy’s Laboratories Limited Calcitonin Salmon Injection USP, 200 I.U. per mL (400 I.U. per 2 mL) Multi-Dose Vial 4/11/2024 No N/A N/A 282 Oracea, NDA 218034 218034 Dr. Reddy’s Laboratories Limited Doxycycline Capsules, 40 mg 4/8/2024 No N/A N/A 281 Narcan, NDA 16636 213573 Fresenius Kabi USA, LLC Naloxone Hydrochloride Injection USP, 0.4 mg/mL and 1 mg/mL Single-Dose Prefilled Syringe 4/2/2024 No N/A N/A 280 Sodium Acetate, NDA 18893 216920 Hikma Pharmaceuticals USA, Inc Sodium Acetate Injection USP, 40 mEq/20 mL (2 mEq/mL) 3/15/2024 Yes No 5/20/2024 279 Entadfi, NDA 215423 218232 Zydus Worldwide DMCC Finasteride and Tadalafil Capsules, 5 mg/5 mg 3/15/2024 Yes Yes N/A 278 Rectiv, NDA 21359 216103 Cosette Pharmaceuticals, Inc Nitroglycerin Ointment USP, 0.4% 2/16/2024 Yes No 2/23/2024 277 Lumify, NDA 208144 216361 Dr. Reddy’s Laboratories SA Brimonidine Tartrate Ophthalmic Solution, 0.025% 2/16/2024 No N/A N/A 276 Dilaudid, NDA 019034 216899 Hikma Pharmaceuticals USA, Inc Hydromorphone Hydrochloride Injection USP, 0.2 mg/mL Single-Dose Prefilled Syringe 2/9/2024 No N/A N/A 275 Dexamethasone, ANDA 087916 216283 Zydus Pharmaceuticals (USA) Inc Dexamethasone Tablets USP, 2 mg 2/7/2024 No N/A N/A 274 Thiola EC, NDA 211843 216990 Torrent Pharmaceuticals Ltd Tiopronin Delayed-Release Tablets, 100 mg and 300 mg 1/30/2024 No N/A N/A 273 Astagraf XL, NDA 204096 215012 Chengdu Suncadia Medicine Co., Limited Tacrolimus Extended-Release Capsules, 0.5 mg, 1 mg, and 5 mg 1/25/2024 No N/A N/A 272 Carafate, NDA 019183 213549 PD Partners III, LLC Sucralfate Oral Suspension, 1 g/10 mL 1/17/2024 No N/A N/A 271 BiDil, NDA 020727 215988 i3 Pharmaceuticals, LLC Isosorbide Dinitrate and Hydralazine Hydrochloride Tablets, 20 mg/37.5 mg 1/17/2024 No N/A N/A 270 Nuplazid, NDA 210793 214493 Zydus Pharmaceuticals (USA) Inc. Pimavanserin Capsules, 34 mg 1/16/2024 No N/A N/A 269 Nuplazid, NDA 207318 214502 Zydus Pharmaceuticals (USA) Inc. Pimavanserin Tablets, 10 mg 1/16/2024 No N/A N/A 268 Indocin, NDA 018332 217883 Novitium Pharma LLC Indomethacin Oral Suspension, USP 25 mg/5 mL 1/12/2024 Yes No 1/12/2024 267 FML, NDA 016851 216348 Amneal EU, Limited Fluorometholone Ophthalmic Suspension USP, 0.1% 1/9/2024 Yes No 1/9/2024 266 Amicar, NDA 015230 213213 Sunny Pharmtech Inc. Aminocaproic Acid Oral Solution USP, 0.25 grams/mL 12/27/2023 No N/A N/A 265 Alrex, NDA 020803 215550 Lupin Limited Loteprednol Etabonate Ophthalmic Suspension, 0.2% 12/26/2023 No N/A N/A 264 Prezista, N021976 214085 Zydus Pharmaceuticals (USA) Inc. Darunavir Tablets, 800 mg 12/13/2023 No N/A N/A 263 ProvayBlue, NDA 204630 215636 Zydus Pharmaceuticals (USA) Inc. Methylene Blue Injection USP, 10 mg/2 mL (5 mg/mL) and 50 mg/10 mL (5 mg/mL) Single-Dose Vials 12/5/2023 No N/A N/A 262 Lotemax, NDA 202872 213956 Slayback Pharma LLC Loteprednol Etabonate Ophthalmic Gel, 0.5% 11/29/2023 No N/A N/A 261 Foscavir, NDA 020068 213987 Beijing Secure Pharmaceutical Co., Ltd. Foscarnet Sodium Injection, 6000 mg/250 mL (24 mg/mL) Single-Dose Bottle for Infusion 11/29/2023 No N/A N/A 260 Corlanor, NDA 206143 213442 Zydus Pharmaceuticals (USA) Inc. Ivabradine Tablets, 5 mg and 7.5 mg 11/29/2023 No N/A N/A 259 Condylox, NDA 020529 211871 Padagis US LLC Podofilox Gel 0.5% 11/22/2023 Yes No 12/13/2023 258 Zovirax, NDA 021478 212361 Alembic Pharmaceuticals Limited Acyclovir Cream, 5% 11/21/2023 Yes No 12/15/2023 257 Revex, NDA 020459 216007 Chengdu Shuode Pharmaceutical Co., Ltd. Nalmefene Hydrochloride Injection, 100 mcg/mL and 2 mg/2 mL (1 mg/mL) Single-Dose Vials 11/15/2023 No N/A N/A 256 Divigel, NDA 022038 216524 Padagis Israel Pharmaceuticals Ltd. Estradiol Gel, 0.1% (0.25 mg, 0.5 mg, 0.75 mg, 1 mg, and 1.25 mg per Packet) 11/14/2023 No N/A N/A 255 AN Sulfur Colloid, NDA 017858 213516 Jubilant DraxImage Inc. Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection 11/9/2023 Yes No 12/4/2023 254 Efudex, NDA 016831 215612 Encube Ethicals Private Limited Fluorouracil Topical Solution USP, 5% 11/2/2023 Yes Yes N/A 253 Aczone, NDA 207154 212657 Padagis US LLC Dapsone Gel, 7.5% 11/1/2023 No N/A N/A 252 Principen, NDA 050056 216554 Aurobindo Pharma Limited Ampicillin Capsules USP, 250 mg and 500 mg 10/31/2023 Yes No 12/11/2023 251 Calcium Gluconate in Sodium, NDA 208418 217689 Somerset Therapeutics Calcium Gluconate Injection USP, 5,000 mg/50 mL (100 mg/mL) Single-Dose Vials (50 mL Fill) and Calcium Gluconate Injection USP, 10,000 mg/100 mL (100 mg/mL) Pharmacy Bulk Package (100 mL Fill) 10/19/2023 Yes – 5,000 mg/50 mL (100 mg/mL); No-10,000 mg/100 mL (100 mg/mL) No 10/20/2023 250 Votrient, NDA 022465 215837 Sun Pharmaceutical Industries Pazopanib Tablets, 200 mg 10/19/2023 No N/A N/A 249 Votrient, NDA 022465 217517 Teva Pharmaceuticals Pazopanib Tablets, 200 mg 10/19/2023 No N/A N/A 248 Tranexamic Acid, NDA 212020 217155 Amneal Pharmaceuticals of New York, LLC Tranexamic Acid in 0.7% Sodium Chloride Injection, 1,000 mg/100 mL (10 mg/mL) 10/16/2023 Yes No 10/19/2023 247 Potassium Phosphates, NDA 212832 216344 Amneal Pharmaceuticals of New York, LLC Potassium Phosphates Injection USP, Phosphorus 15 mmol/5 mL (3 mmol/mL) and Potassium 22 mEq/5 mL (4.4 mEq/mL), Phosphorous 45 mmol/15 mL (3 mmol/mL) and Potassium 66 mEq/15 mL (4.4 mEq/mL) in Single-Dose Vials; Phosphorus 150 mmol/50 mL (3 mmol/mL) and Potassium 220 mEq/50 mL (4.4 mEq/mL) in Pharmacy Bulk Package Vials 10/10/2023 No N/A N/A 246 Bridion, NDA 022225 214290 Zydus Pharmaceuticals (USA) Inc. Sugammadex Injection, 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL), Single-Dose Vials 10/4/2023 No N/A N/A 245 Glucotrol, NDA 017783 214874 Rubicon Research Private Limited Glipizide Tablets USP, 2.5 mg 10/3/2023 Yes No 10/18/2023 244 Potassium Phosphates, NDA 212832 216274 American Regent, Inc. Potassium Phosphates Injection USP, phosphorus 15 mmol/5 mL (3 mmol/mL) and potassium 22 mEq/5 mL (4.4 mEq/mL), phosphorus 45 mmol/15 mL (3 mmol/mL) and potassium 66 mEq/15 mL (4.4 mEq/mL) in Single-Dose Vials; phosphorus 150 mmol/50 mL (3 mmol/mL) and potassium 220 mEq/50 mL (4.4 mEq/mL) in Pharmacy Bulk Package Vials 10/2/2023 Yes No 10/16/2023 – Phosphorus 15 mmol/5 mL (3 mmol/mL) and Potassium 22 mEq/5 mL (4.4 mEq/mL) Single-dose Vials; 10/13/2023 – Phosphorous 45 mmol/15 mL (3 mmol/mL) and Potassium 66 mEq/15 mL (4.4 mEq/mL) in Single-Dose Vials; Phosphorus 150 mmol/50 mL (3 mmol/mL) and Potassium 220 mEq/50 mL (4.4 mEq/mL) in Pharmacy Bulk Package Vials 243 Xeljanz, NDA 213082 216878 Slayback Pharma LLC Tofacitinib Oral Solution, 1 mg/mL 9/25/2023 No N/A N/A 242 AK-FLUOR, 10% and 25%, NDA 022186 215709 Nexus Pharmaceuticals Inc. Fluorescein Injection USP, 500 mg/5 mL (100 mg/mL) and 500 mg/2 mL (250 mg/mL) Single-Dose Vials 9/25/2023 Yes No 10/24/2023 241 Ortho Evra, NDA 21180 214594 Zydus Noveltech Inc. Norelgestromin and Ethinyl Estradiol Transdermal System, 150 mcg/35 mcg per day 9/14/2023 No N/A N/A 240 Gadavist, NDA 201277 216081 Jiangsu Hengrui Pharmaceuticals Co., Ltd. Gadobutrol Injection, 30 mmol/30 mL (1 mmol/mL) and 65 mmol/65 mL (1 mmol/mL) Imaging Bulk Package 9/8/2023 Yes No 11/1/2023 239 Calcium Gluconate in Sodium Chloride, NDA 208418 217174 Amneal Pharmaceuticals LLC Calcium Gluconate in Sodium Chloride Injection, 1000 mg/50 mL and 2000 mg/100 mL (20 mg/mL) Single-Dose Containers 9/5/2023 Yes No 9/12/2023 238 Vyvanse, NDA 021977 215330 Rhodes Pharmaceutical L.P. Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg 8/25/2023 No N/A N/A 237 Combigan, NDA 021398 215230 Syneos Health, LLC Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution, 0.2%/0.5% 8/25/2023 No N/A N/A 236 Vyvanse, NDA 021977 214547 Norwich Pharmaceuticals, Inc. Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg 8/25/2023 No N/A N/A 235 Dexamethasone, ANDA 088316 217695 Apotex Corp. Dexamethasone Tablets USP, 1 mg 8/23/2023 Yes No 11/1/2023 234 Zinc Sulfate, NDA 209377 217074 Zydus Pharmaceuticals (USA) Inc. Zinc Sulfate Injection USP, 10 mg/10 mL (1 mg/mL), 30 mg/10 mL (3 mg/mL), and 25 mg/5 mL (5 mg/mL) Pharmacy Bulk Package Vials 8/22/2023 No N/A N/A 233 Retin-A-Micro, NDA 020475 215609 Encube Ethicals Private Limited Tretinoin Gel (Microsphere), 0.08% 8/22/2023 Yes No 9/8/2023 232 Calcium Gluconate in Sodium Chloride, NDA 208418 216541 B. Braun Medical, Inc. Calcium Gluconate Injection 10,000 mg/100 mL (100 mg/mL) Pharmacy Bulk Package 8/21/2023 Yes No 11/2/2023 231 Balcoltra, NDA 208612 214640 Xiromed Pharma Espana, S.L. Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets, 0.1 mg/0.02 mg and 75 mg 8/16/2023 No N/A N/A 230 Zonalon, NDA 020126 212357 Amneal Pharmaceuticals, LLC Doxepin Hydrochloride Cream, 5% 8/16/2023 No N/A N/A 229 Thiola EC, NDA 211843 216278 Amneal Pharmaceuticals of New York, LLC Tiopronin Delayed-Release Tablets, 300 mg 8/15/2023 No N/A N/A 228 Lithium Citrate, NDA 018421 218036 Rubicon Research Private Limited Lithium Oral Solution USP, 8 mEq/5 mL 8/14/2023 Yes No 9/20/2023 227 Potassium Chloride, ANDA 080205 217704 Nexus Pharmaceuticals Inc. Potassium Chloride for Injection Concentrate USP, 20 mEq/10 mL (2 mEq/mL) and 40 mEq/20 mL (2 mEq/mL) Single-Dose Vials 8/14/2023 Yes No 9/12/2023 226 Lexette, NDA 210566 215266 Padagis US LLC Halobetasol Propionate Topical Foam, 0.05% 8/11/2023 No N/A N/A 225 Lotemax, NDA 202872 2215384 Sun Pharmaceutical Industries, Inc. Loteprednol Etabonate Ophthalmic Gel, 0.5% 8/9/2023 No N/A N/A 224 Denavir, NDA 020629 216981 Torrent Pharma Inc. Penciclovir Cream, 1% 8/7/2023 Yes No 9/1/2023 223 Vancomycin, NDA 209481 217401 Eugia US LLC Vancomycin Hydrochloride for Injection USP, 1.25 g/vial and 1.5 g/vial (Single-Dose vials) 8/4/2023 No N/A N/A 222 Indocin, NDA 017814 216184 Zydus Worldwide DMCC Indomethacin Suppositories USP, 50 mg 8/2/2023 Yes No 8/3/2023 221 Azopt, NDA 020816 211914 Padagis USA LLC Brinzolamide Ophthalmic Suspension USP, 1% 7/28/2023 Yes No 10/10/2023 220 Cardene, NDA 019488 215377 Senores Pharmaceuticals, Inc. Nicardipine Hydrochloride Capsules, 20 mg and 30 mg 7/17/2023 Yes No 9/19/2023 219 Sodium Phenylacetate and Sodium Benzoate, NDA 215025 217526 Navinta LLC Sodium Phenylacetate and Sodium Benzoate Injection, 10% / 10% (2g – 2 g/20 mL [0.1 g – 0.1 g/mL])Single-Dose Vial 7/14/2023 Yes No 9/22/2023 218 Sodium Chloride 23.4%, NDA 019329 217796 Fresenius Kabi USA, LLC 23.4% Sodium Chloride Injection USP, 800 mEq/200 mL (4 mEq/mL) Pharmacy Bulk Package 7/11/2023 Yes N/A 7/27/2023 217 Sterile Water, NDA 018801 217536 Nexus Pharmaceuticals Inc. Sterile Water for Injection USP, 20 mL Single-Dose Vials 7/11/2023 Yes Yes N/A 216 Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride, NDA 050786 217511 RinconPharma LLC Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride Capsules, 140 mg/125mg/125 mg 7/3/2023 Yes No 7/3/2023 215 Vancomycin Hydrochloride, NDA 209481 217489 Hikma Pharmaceuticals USA Inc. Vancomycin Hydrochloride for Injection USP, 1.25 g/vial and 1.5 g/vial Single-Dose Vial 6/29/2023 Yes No 8/16/2023 214 Vancocin Hydrochloride, ANDA 061667 215338 Amneal Pharmaceuticals LLC Vancomycin Hydrochloride for Oral Solution USP, 250 mg/5 mL (50 mg/mL) 6/23/2023 Yes No 6/23/2023 213 Nasonex, NDA 215712 217460 Amneal Pharmaceuticals LLC Mometasone Furoate Nasal Spray, 50 mcg/spray (OTC) 6/14/2023 Yes Yes N/A 212 Katerzia, NDA 211340 215035 Amneal Pharmaceuticals LLC Amlodipine Benzoate Oral Suspension, 1 mg/mL (150 mL) 6/13/2023 No N/A N/A 211 Fleqsuvy, NDA 215602 217252 Slayback Pharma LLC Baclofen Oral Suspension, 25 mg/5 mL (5 mg/mL) 6/8/2023 No N/A N/A 210 Foscarnet Sodium Injection, 6,000 mg/250 mL (24 mg/mL) Single-Dose Bottle for Infusion, NDA 020068 213807 Emcure Pharmaceuticals Ltd. Foscarnet Sodium Injection, 6,000 mg/250 mL (24 mg/mL) Single-Dose Bottle for Infusion 6/5/2023 No N/A N/A 209 Arranon, NDA 021877 215057 Nexus Pharmaceuticals Inc. Nelarabine Injection, 250 mg/50 mL (5 mg/mL) Single-Dose Vial 6/2/2023 No N/A N/A 208 Fosamax, NDA 021575 214512 Novitium Pharma LLC Alendronate Sodium Oral Solution, 70 mg (base)/75 mL 5/11/2023 Yes No 5/24/2023 207 Dexamethasone, ANDA 081916 217696 Novitium Pharma LLC Dexamethasone Tablets USP, 2 mg 5/9/2023 No N/A N/A 206 Calcium DisodiumVersenate, NDA 008922 216435 Casper Pharma LLC Edetate Calcium Disodium Injection, USP, 1,000 mg/5 mL (200 mg/mL) Single-Dose Vial 5/2/2023 Yes No 7/12/2023 205 Celontin, NDA 010596 217213 Novitium Pharma LLC Methsuximide Capsules USP, 300 mg 5/1/2023 Yes No 5/1/2023 204 Dexamethasone, ANDA 087916 217538 Bionpharma Inc. Dexamethasone Tablets USP, 2 mg 4/26/2023 No N/A N/A 203 Tazorac, NDA 020600 213079 Padagis Israel Pharmaceuticals Ltd. Tazarotene Gel, 0.05% and 0.1% 4/25/2023 No N/A N/A 202 Alrex, NDA 020803 215933 Akorn Operating Company LLC Loteprednol Etabonate Ophthalmic Suspension, 0.2% 4/12/2023 Yes Yes N/A 201 Uceris, NDA 205613 215328 Padagis Israel Pharmaceuticals Ltd. Budesonide Rectal Foam, 2 mg/dose 4/12/2023 Yes No 4/27/2023 200 Paraflex, NDA 011300 214702 Corepharma, LLC Chlorzoxazone Tablets USP, 250 mg 4/10/2023 No N/A N/A 199 Arranon, NDA 021877 216346 Amneal Pharmaceuticals LLC Nelarabine Injection, 250 mg/50 mL (5 mg/mL), Single-Dose Vial 4/4/2023 No N/A N/A 198 Alphagan P, NDA 021262 215225 Syneos Health, LLC Brimonidine Tartrate Ophthalmic Solution, 0.15% 3/29/2023 No N/A N/A 197 Amitiza, NDA 021908 214131 Zydus Pharmaceuticals (USA) Inc. Lubiprostone Capsules, 8 mcg and 24 mcg 3/23/2023 No N/A N/A 196 Enstilar, NDA 207589 214688 Glenmark Pharmaceuticals Inc., USA Calcipotriene and Betamethasone Dipropionate Foam, 0.005%/0.064% 3/21/2023 No N/A N/A 195 Tazorac, NDA 020600 213644 Solaris Pharma Corporation Tazarotene Gel, 0.05% and 0.1% 3/20/2023 No N/A N/A 194 Prednisolone, ANDA 080354 215673 Aurobindo Pharma Limited Prednisolone Tablets USP, 5 mg 3/17/2023 Yes No 5/22/2023 193 Arranon, NDA 021877 214809 Shorla Pharma Limited Nelarabine Injection, 250 mg/50 mL (5 mg/mL), Single-Dose Vial 3/3/2023 No N/A N/A 192 Advil Dual Action with Acetaminophen, NDA 211733 214836 L. Perrigo Company Acetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC) 2/28/2023 No N/A N/A 191 Thiola EC, NDA 211843 217219 Par Pharmaceutical Inc. Tiopronin Delayed-Release Tablets, 100 mg and 300 mg 2/24/2023 No N/A N/A 190 Zonalon, NDA 021026 215408 Teva Pharmaceutical Development, Inc. Doxepin Hydrochloride Cream, 5% 2/17/2023 Yes No 2/17/2023 189 Trokendi XR, NDA 201635 216167 Zydus Pharmaceuticals (USA) Inc. Topiramate Extended-Release Capsules, 200 mg 2/9/2023 No N/A N/A 188 Parafon Forte DSC, NDA 011529 212047 Appco Pharma LLC Chlorzoxazone Tablets USP, 375 mg and 750 mg 1/27/2023 No N/A N/A 187 Phenylephrine Hydrochloride, NDA 207926 216496 Mankind Pharma Limited Phenylephrine Hydrochloride Ophthalmic Solution USP, 10% 1/11/2023 Yes No 1/18/2023 186 Arranon, NDA 021877 216038 MeithealPharmaceuticals, Inc. Nelarabine Injection, 250 mg/50 mL (5 mg/mL) Single-Dose Vial 1/10/2023 No N/A N/A 185 Orfadin, NDA 021232 215908 Torrent Pharma Inc. Nitisinone Capsules, 20 mg 1/9/2023 Yes Yes N/A 184 Zinc Sulfate, NDA 209377 216145 Fresenius Kabi USA, LLC Zinc Sulfate Injection USP, 10 mg/10 mL (1 mg/mL), 30 mg/10 mL (3 mg/mL) and 25 mg/5 mL (5 mg/mL) Pharmacy Bulk Package 12/27/2022 Yes (10 mg/10 mL); No (30 mg/10 mL); No (25 mg/5 mL) No 2/15/2023 183 Cupric Sulfate, NDA 019350 216324 American Regent, Inc. Cupric Sulfate Injection USP, 4 mg/10 mL (0.4 mg/mL) Pharmacy Bulk Package 12/26/2022 Yes Yes N/A 182 Uptravi, NDA 207947 214302 Zydus Worldwide DMCC Selexipag Tablets, 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,000 mcg, 1,200 mcg, 1,400 mcg, and 1,600 mcg 12/21/2022 No N/A N/A 181 Perforomist, NDA 22007 215621 Slayback Pharma LLC Formoterol Fumarate Solution 20 mcg/2 mL per Unit Dose Vial 12/13/2022 No N/A N/A 180 Potassium Chloride, NDA 206814 211665 Strides Pharma Global Pte Limited Potassium Chloride Oral Solution USP, 40 mEq/15 mL (20%) 11/17/2022 No N/A N/A 179 AmBisome Liposome, NDA 050740 214010 Eugia US LLC Amphotericin B Injection, 50 mg/vial Single-Dose Vial 11/17/2022 No N/A N/A 178 Durezol, NDA 022212 214894 Dr. Reddy’s Laboratories Limited Difluprednate Ophthalmic Emulsion, 0.05% 11/16/2022 No N/A N/A 177 Calcium Gluconate, NDA 208418 213071 Nivagen Pharmaceuticals, Inc. Calcium Gluconate Injection USP, 1,000 mg per 10 mL (100 mg per mL) Single-Dose Vial 10/14/2022 Yes No 11/6/2022 176 Briviact, NDA 205836 214501 Zydus Pharmaceuticals (USA) Inc. Brivaracetam Tablets, 10 mg, 25 mg, 50 mg, 75 mg, and 100 mg 10/3/2022 No N/A N/A 175 Phenylephrine Hydrochloride, NDA 207926 216859 Mankind Pharma Limited Phenylephrine Hydrochloride Ophthalmic Solution USP, 2.5% w/v (2 mL fill) 9/29/2022 Yes No 10/7/2022 174 Pathocil, NDA 050011 216845 Aurobindo Pharma USA, Inc. Dicloxacillin Sodium Capsules USP, 250 mg and 500 mg 9/23/2022 Yes No 9/30/2022 173 Timoptic in Ocudose, NDA 019463 216533 Ingenus Pharmaceuticals, LLC Timolol Maleate Ophthalmic Solution USP, 0.25% (base) and 0.5% (base), Single-Dose Vials 9/13/2022 No N/A N/A 172 Tazorac, NDA 020600 215433 Cosette Pharmaceuticals, Inc. Tazarotene Gel, 0.05% 9/13/2022 Yes No 9/14/2022 171 Tazorac, NDA 020600 214136 Cosette Pharmaceuticals, Inc. Tazarotene Gel, 0.01% 9/13/2022 Yes No 9/14/2022 170 Carafate, NDA 19183 212913 Mylan Pharmaceuticals, Inc. Sucralfate Oral Suspension, 1 g/10 mL 9/12/2022 No N/A N/A 169 Dexamethasone, ANDA 087916 216295 Amneal Pharmaceuticals LLC Dexamethasone Tablets USP, 2 mg 9/8/2022 Yes No 9/9/2022 168 Lyrica CR, NDA 209501 215577 Zydus Pharmaceuticals (USA) Inc. Pregabalin Extended-Release Tablets, 82.5 mg, 165 mg, and 330 mg 8/26/2022 No N/A N/A 167 Cetrotide, NDA 021197 215737 Akorn Operating Company LLC Cetrorelix Acetate for Injection, 0.25 mg/vial, Single-Dose 8/12/2022 Yes No 10/24/2022 166 Divigel, NDA 022038 211783 Chemo Research S.L. Estradiol Gel, 0.1% 8/10/2022 Yes No 10/10/2022 165 Clindagel, NDA 050782 214668 Amneal Pharmaceuticals LLC Clindamycin Phosphate Gel USP, 1% 8/5/2022 Yes No 8/5/2022 164 Bactroban, NDA 050746 212465 Padagis Israel Pharmaceuticals Ltd. Mupirocin Cream USP, 2% 8/3/2022 No N/A N/A 163 Taytulla, NDA 204426 213418 Glenmark Pharmaceuticals Limited Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate Capsules, 1 mg/20 mcg 7/27/2022 No N/A N/A 162 Vasostrict, NDA 204485 211857 Amphastar Pharmaceuticals, Inc. Vasopressin Injection USP, 20 Units/mL Single-Dose Vials 7/18/2022 No N/A N/A 161 Nalfon, NDA 017604 214475 Rising Pharma Holdings, Inc. Fenoprofen Calcium Capsules USP, 400 mg 7/18/2022 Yes No 8/15/2022 160 Atropine Sulfate, NDA 206289 214752 Amneal Pharmaceuticals LLC Atropine Sulfate Ophthalmic Solution USP, 1% 7/14/2022 No N/A N/A 159 Isordil, NDA 012093 215723 Rubicon Research Private Limited Isosorbide Dinitrate Tablets USP, 40 mg 7/8/2022 No N/A N/A 158 Neostigmine Methylsulfate, NDA 203629 216291 Dr. Reddy’s Laboratories Limited Neostigmine Methylsulfate Injection USP, 3 mg/3 mL (1 mg/mL) Single-Dose Prefilled Syringes 7/6/2022 Yes No 7/25/2022 157 Plasma-Lyte 148 in Water,NDA 017378 215370 Fresenius Kabi USA, LLC Multiple Electrolytes Injection Type 1 USP, pH 5.5, Single-Dose Containers 6/29/2022 Yes Yes N/A 156 Carbaglu, NDA 022562 213395 Navinta LLC Carglumic Acid Tablets for Oral Suspension, 200 mg 6/22/2022 No N/A N/A 155 Narcan, NDA 208411 211951 Padagis Israel Pharmaceuticals Ltd. Naloxone Hydrochloride Nasal Spray, 4 mg/spray 6/21/2022 No N/A N/A 154 Infants’ Advil, NDA 020812 214071 Strides Pharma Inc. Ibuprofen Oral Suspension USP, 50 mg/1.25 mL (40 mg/mL) (OTC) 6/9/2022 Yes Yes N/A 153 Plasma-Lyte A, NDA017378 215371 Fresenius Kabi USA, LLC Multiple Electrolytes Injection Type 1 USP, pH 7.4, Single-Dose Containers 6/8/2022 Yes Yes N/A 152 Epiduo Forte, NDA 207917 214553 Zydus Pharmaceuticals (USA) Inc. Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% 6/3/2022 No N/A N/A 151 Epiduo Forte, NDA 207917 212464 Padagis US, LLC Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5% 5/31/2022 No N/A N/A 150 Atropine Sulfate, NDA 214652 216120 American Regent, Inc. Atropine Sulfate Injection USP, 0.4 mg/mL and 1 mg/mL Single-Dose Vials 5/26/2022 Yes No 8/2/2022 149 Brovana, NDA 021912 215385 Sun Pharmaceutical Industries Ltd Arformoterol Tartrate Inhalation Solution, 15 mcg/2 mL, Unit-Dose Vial 5/26/2022 No N/A N/A 148 Alimta, NDA 021462 214073 Zydus Pharmaceuticals (USA) Inc. Pemetrexed for Injection USP, 1000 mg/vial 5/25/2022 No N/A N/A 147 Lexiscan, NDA 022161 214252 International Medication Systems, Limited Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL) Single-Dose Pre-Filled Syringe 5/23/2022 No N/A N/A 146 Visipaque, NDA 20351 214271 Jiangsu Hengrui Pharmaceuticals Co., Ltd. Iodixanol Injection USP, 270 mg Iodine/mL and 320 mg Iodine/mL Single Dose Bottles 5/19/2022 Yes No 7/13/2022 145 Pentasa, NDA 020049 214585 Sun Pharmaceutical Industries Inc. Mesalamine Extended Release Capsules USP, 500 mg 5/11/2022 Yes No

5/18/2022

144 Brovana, NDA 021912 214779 Alembic Pharmaceuticals Limited Arformoterol Tartrate Inhalation Solution, 15 mcg (base)/2 mL Unit-dose Vial 5/10/2022 No N/A N/A 143 Zinc Sulfate, NDA 209377 216249 Gland Pharma Limited Zinc Sulfate Injection USP, 30 mg/10 mL (3 mg/mL) and 25 mg/5 mL (5 mg/mL) 5/3/2022

Yes

Yes

No

Yes

6/27/2022 (30 mg/10 mL (3 mg/mL)) 25 mg/5 mL (5 mg/mL) 142 Targretin, NDA 021056 215398 Amneal Pharmaceuticals LLC Bexarotene Gel, 1% 4/27/2022 Yes No 5/17/2022 141 AquaMEPHYTON, NDA 012223 214596 Cipla Limited Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL and 10 mg/mL Single-Dose Vials 4/22/2022 Yes No 5/3/2022 140 AquaMEPHYTON, NDA 012223 212424 Cipla Limited Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL and 10 mg/mL Single-Dose Ampules 4/22/2022 Yes   5/3/2022 (by ANDA 214596) 139 Sinequan, NDA 016798 213796 Edenbridge Pharmaceuticals, LLC Doxepin Hydrochloride Capsules USP, 150 mg 4/19/2022 Yes No 5/2/2022 138 Mestinon, NDA 015193 212405 Milla Pharmaceuticals, Inc Pyridostigmine Bromide Solution USP, 60 mg/5 mL 4/19/2022 No N/A N/A 137 Lexiscan, NDA 022161 213210 Dr. Reddy’s Laboratories, Inc. Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL) Single-Dose Pre-filled Syringe 4/11/2022 No N/A N/A 136 Ganirelix Acetate, NDA 021057 212613 Amphastar Pharmaceuticals, Inc. Ganirelix Acetate Injection, 250 mcg/0.5 mL Prefilled Syringe 4/7/2022 No N/A N/A 135 Noxafil, NDA 205053 212500 Dr. Reddy’s Laboratories, Inc. Posaconazole Delayed-Release Tablets, 100 mg 4/7/2022 No N/A N/A 134 Butalbital and Acetaminophen, ANDA 89988 214088 Havix Group Inc. Butalbital and Acetaminophen Tablets, 25 mg/325 mg 4/7/2022 Yes Yes N/A 133 BiDil, NDA 020727 215586 RiconPharma LLC Isosorbide Dinitrate and Hydralazine Hydrochloride Tablets, 20 mg/37.5 mg 4/6/2022 Yes No 4/12/2022 132 Revatio, NDA 203109 211638 Lupin Pharmaceuticals, Inc. Sildenafil for Oral Suspension, 10 mg/mL 3/23/2022 No N/A N/A 131 Carafate, NDA 019183 211884 VistaPharm, Inc. Sucralfate Oral Suspension, 1 g/10 mL 3/15/2022 Yes No 3/15/2022 130 Brovana, NDA 021912 214736 VistaPharm, Inc. Arformoterol Tartrate Inhalation Solution, 15 mcg (base)/2 mL, Unit-Dose Vial 3/2/2022 No N/A N/A 129 Apokyn,NDA 021264 212025 Sage Chemical, Inc. Apomorphine Hydrochloride Injection, 30 mg/3 mL (10 mg/mL), Single-Patient-Use Glass Cartridge 2/23/2022 Yes No 2/25/2022 128 Veltin, NDA 050803 212845 Solaris Pharma Corporation Clindamycin Phosphate and Tretinoin Gel, 1.2%/0.025% 2/10/2022 Yes No 4/12/2022 127 Lanoxin, NDA 020405 214982 Aurobindo Pharma Limited Digoxin Tablets USP, 0.0625 mg 2/8/2022 Yes No 2/17/2022 126 Revex, NDA 020459 212955 Purdue Pharma L.P. Nalmefene Hydrochloride Injection, 2 mg/2 mL (1 mg/mL) Single-Dose Vials 2/8/2022 Yes Relinquished N/A 125 Cystadane, NDA 020576 210508 Lukare Medical, LLC Betaine Anhydrous for Oral Solution, 180 grams/bottle 1/28/2022 No N/A N/A 124 Atropine Sulfate, NDA 021146 215342 Amneal EU, Limited Atropine Sulfate Injection USP, 0.5 mg/5 mL (0.1 mg/mL) Single-Dose Syringe 1/26/2022 No N/A N/A 123 Monurol, NDA 050717 211881 Cipla USA, Inc. Fosfomycin Tromethamine Suspension 3 g (base) Single-Dose Sachet 1/26/2022 No N/A N/A 122

Migranal, NDA 020148

214105 Amneal Pharmaceuticals LLC Dihydroergotamine Mesylate Nasal Spray, 4 mg/mL (1 mL Vial) 1/4/2022 No N/A N/A 121 AmBisome Liposome, NDA 050740 212514 Sun Pharmaceutical Industries Inc. Amphotericin B Liposome for Injection, 50 mg/vial Single-Dose Vial 12/14/2021 Yes No 2/15/2022 120 Timoptic, NDA 019463 212592 Pharmaceutical Project Solutions, Inc. Timolol Maleate Ophthalmic Solution USP, 0.25% (base) and 0.5% (base), Single-Dose Vials 12/13/2021 Yes No 2/26/2022 119 Atropine Sulfate, NDA 209260 213561 Hikma Pharmaceuticals USA Inc.

Atropine Sulfate Injection USP, 8 mg/20 mL (0.4 mg/mL) Multi-Dose Vial

12/1/2021 No N/A N/A 118 Atropine Sulfate, NDA 206289 215624 Apotex Atropine Sulfate Ophthalmic Solution, USP 1% 11/26/2021 Yes No 11/26/2021 117 Cystadane, NDA 20576 214864 Novitium Pharma Betaine Anhydrous for Oral Solution, 180 grams/bottle 11/23/2021 Yes No 2/3/2022 116 Isordil, NDA 012093 211290 Par Pharmaceutical, Inc. Isosorbide Dinitrate Tablets USP, 40 mg 11/23/2021 Yes No 12/21/2021 115 Perforomist, NDA 022007 215078 Alembic Pharmaceuticals Limited Formoterol Fumarate Inhalation Solution, 20 mcg/2 mL per Unit-Dose Vial 11/22/2021 No N/A No 114 Revatio, NDA 203109 212312 Tris Pharma, Inc. Sildenafil for Oral Suspension, 10 mg/mL 11/17/2021 No N/A No 113 Arranon, NDA 021877 215037 Zydus Pharmaceuticals (USA) Inc. Nelarabine Injection, 250 mg/50 mL (5 mg/mL), SingleDose Vial 11/17/2021 Yes No 11/23/2021 112 Bactroban, NDA 050746 213053 Aleor Dermaceuticals Limited Mupirocin Cream USP, 2% 11/16/2021 Yes No 12/29/2021 111 Librax, NDA012750 211476 Teva Pharmaceuticals USA, Inc. Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules USP, 5 mg/2.5 mg 11/2/2021 No N/A N/A 110 Prexxartan, NDA 209139 214102 Novitium Pharma, LLC Valsartan Oral Solution, 20 mg/5 mL (4 mg/mL) 11/2/2021 Yes Yes N/A 109 Monurol, NDA 050171 214554 Alkem Laboratories Limited Fosfomycin Tromethamine Granules for Oral Solution, 3 g (base) Single-Dose Packet 10/21/2021 No   N/A 108 Decadron, NDA 011664 215106 Amneal EU, Limited Dexamethasone Tablets USP, 4 mg and 6 mg 10/14/2021 Yes No 4 mg – 10/22/2021; 6 mg – 10/21/2021 107 Carbaglu, NDA 016636 213729 Novitium Pharma, LLC Carglumic Acid Tablets for Oral Suspension, 200 mg 10/13/2021 Yes N0 12/20/2021 106 Mexitil, NDA 018873 214089 Aavis Pharmaceuticals Mexiletine Hydrochloride Capsules USP, 150 mg, 200 mg, and 250 mg 10/1/2021 No N/A N/A 105 Zomig, NDA 021450 212469 Padagis US, LLC Zolmitriptan Nasal Spray USP, 2.5 mg/spray and 5 mg/spray 9/30/2021 No N/A N/A 104 Absorica, NDA 021951 212333 Upsher-Smith Laboratories, LLC Isotretinoin Capsules USP, 10 mg, 20 mg, and 30 mg 9/21/2021 No N/A N/A 103 Quinaglute, NDA 016647 212589 Eywa Pharma, Inc. Quinidine Gluconate Extended-Release Tablets USP, 324 mg 9/17/2021 Yes Yes N/A 102 Paxil, NDA 020710 215003 Novitium Pharma LLC Paroxetine Oral Suspension, 10 mg (base)/5 mL 9/3/2021 Yes No 9/13/2021 101 Ortho Evra, NDA 021180 213977 Teva Pharmaceuticals USA, Inc. Onsura (Norelgestromin and Ethinyl Estradiol Transdermal System), 150 mcg/35 mcg per day 8/25/2021 No N/A N/A 100 Aramine, NDA 009509 211304 Slayback Pharma LLC Metaraminol Bitartrate Injection USP, 100 mg (base)/10 mL (10 mg (base)/mL), Multi-Dose Vial 8/24/2021 Yes Yes N/A 99 Cuprimine, NDA 019853 213293 InvaGen Pharmaceuticals, Inc. Penicillamine Capsules USP, 250 mg 8/19/2021 No N/A N/A 98 Clindagel, NDA 050782 212842 Solaris Pharma Corporation Clindamycin Phosphate Gel USP, 1% 8/13/2021 No N/A N/A 97 Loperamide Hydrochloride, NDA 21855 213070 Strides Pharma, Inc. Loperamide Hydrochloride Capsules USP, 2 mg (OTC) 8/11/2021 Yes No 10/22/2021 96 Paraflex, NDA 011300 215158 Havix Group, Inc. Chlorzoxazone Tablets USP, 250 mg 7/29/2021 Yes No 9/30/2021 95 Daraprim, NDA 008578 211271 Alvogen Pyrimethamine Tablets USP, 25 mg 7/27/2021 Yes No 10/4/2021 94 Ery-Tabs, ANDA 062298 211975 Torrent Pharma Inc. Erythromycin Delayed-Release Tablets USP, 250 mg and 500 mg 7/26/2021 Yes No 10/4/2021 93 Atropine Sulfate, NDA 021146 212868 Accord Healthcare Inc. Atropine Sulfate Injection USP, 0.25 mg/5 mL (0.05 mg/mL), 0.5 mg/5 mL (0.1 mg/mL), 1 mg/10 mL (0.1 mg/mL) Single-Dose Syringe 7/26/2021 Yes No 7/30/2021 92 Taytulla, NDA 204426 214292 Amneal Pharmaceuticals Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate Capsules, 1 mg/20 mcg 7/20/2021 No N/A N/A 91 Theophylline, ANDA 90430 212184 Glenmark Pharmaceuticals Limited Theophylline Extended-Release Tablets, 450 mg 6/3/2021 Yes No 6/11/2021 90 Thorazine, NDA 009149 214542 Genus Lifesciences Inc. Chlorpromazine Hydrochloride Oral Concentrate USP, 30 mg/mL and 100 mg/mL 6/2/2021 Yes No 8/2/2021 89 Miacalcin Injection, NDA 017808 212416 Custopharm, Inc. Calcitonin Salmon Injection USP, 200 I.U. per mL (400 I.U. per 2 mL) Multi-Dose Vial 5/14/2021 Yes No 5/14/2021 88 Revatio, NDA 203109 213014 Hetero Labs Limited Sildenafil for Oral Suspension, 10 mg/mL 5/11/2021 No N/A N/A 87 Librax, NDA 012750 214698 Dr. Reddy’s Laboratories Limited Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules USP, 5 mg/2.5 mg 5/10/2021 No N/A N/A 86 Sodium Acetate, NDA 018893 214805 Milla Pharmaceuticals, Inc. Sodium Acetate Injection USP, 100 mEq/50 mL (2 mEq/mL) and 200 mEq/100 mL (2 mEq/mL) Pharmacy Bulk Package Vials 5/4/2021 Yes No 7/7/2021 85 Thiola, NDA 019569 214326 Teva Pharmaceuticals USA, Inc. Tiopronin Tablets, 100 mg 4/26/2021 No N/A N/A 84 Librax, NDA 012750 214065 Alkem Laboratories Limited Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules USP, 5 mg/2.5 mg 4/26/2021 No N/A N/A 83 Bentyl, NDA 007961 214721 Novitium Pharma LLC Dicyclomine Hydrochloride Oral Solution USP, 10 mg/5 mL 4/23/2021 No N/A N/A 82 Foscavir, NDA 020068 213001 Gland Pharma Limited Foscarnet Sodium Injection, 6000 mg/250 mL (24 mg/mL) 4/21/2021 Yes No 7/1/2021 81 Thorazine, NDA 009149 212144 Glenmark Pharmaceuticals Limited Chlorpromazine Hydrochloride Tablets USP, 10 mg, 25 mg, 50 mg, 100 mg and 200 mg 3/23/2021 Yes No 3/24/2021 80 Cardizem SR, NDA 019471 212317 Glenmark Pharmaceuticals Limited Diltiazem Hydrochloride Extended-Release Capsules USP, 60 mg, 90 mg, and 120 mg 3/22/2021 Yes No 3/30/2021 79 Atropine Sulfate,NDA 209260 213424 Accord Healthcare Inc. Atropine Sulfate Injection USP, 8 mg/20 mL (0.4 mg/mL), Multiple-Dose Vial 3/19/2021 Yes No 3/25/2021 78 Lotemax, NDA 020583 212450 Sun Pharmaceutical Industries Inc. Loteprednol Etabonate Ophthalmic Suspension, 0.5% 2/26/2021 Yes No 5/6/2021 77 Ortho Evra, NDA021180 213950 Amneal Norelgestromin and Ethinyl Estradiol Transdermal System, 150/35 mcg per day 2/25/2021 Yes No 2/26/2021 76 Northera NDA 203202 211818 Zydus Pharmaceuticals (USA) Inc. Droxidopa Capsules, 100 mg, 200 mg, 300 mg 2/18/2021 No N/A N/A 75 Lotemax, NDA 202872 212080 Akorn Operating Company LLC Loteprednol Etabonate Ophthalmic Gel, 0.5% 2/10/2021 No N/A N/A 74 Jadenu, NDA 207968 214194 Amneal Deferasirox Oral Granules, 180 mg and 360 mg 2/9/2021 No N/A N/A 73 Kenalog, NDA 011600 212460 Perrigo Israel Pharmaceuticals Ltd. Triamcinolone Acetonide Ointment USP, 0.05% 2/5/2021 No N/A N/A 72 Sabril, NDA 020427 211539 Dr. Reddy’s Laboratories Limited Vigabatrin Tablets USP, 500 mg 1/29/2021 Yes No 2/1/2021 71 Eveko, NDA 209905 212186 Glemark Pharmaceuticals Limited Amphetamine Sulfate Tablets USP, 5 mg and 10 mg 1/27/2021 No N/A N/A 70 Mexitil, NDA 018873 214352 RiconPharma LLC Mexiletine Hydrochloride Capsules USP, 150 mg, 200 mg and 250 mg 1/25/2021 No N/A N/A 69 Argatroban, NDA 203049 214235 Caplin Steriles Limited Argatroban Injection, 50 mg/50 mL (1 mg/mL) Single-Dose Vial 1/21/2021 Yes Yes N/A 68 Narcan, NDA 016636 213279 Aurobindo Pharma Limited Naloxone Hydrochloride Injection USP, 2 mg/mL (1 mg/mL) prefilled Syringes 1/14/2021 No N/A N/A 67 Taytulla, NDA 204426 212706 Slayback Pharma LLC Merzee (Norethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate Capsules, 1 mg/20 mcg) 12/18/2020 Yes No 1/18/2021 66 Jublia, NDA 203567 211827 Teva Pharmaceuticals USA, Inc. 12/16/2020 No N/A N/A 65 Jublia, NDA 203567 211851 Perrigo Pharma International DAC Efinaconazole Topical Solution, 10% 12/16/2020 NO N/A N/A 64 Amicar, NDA 015197 211629 ANI Pharmaceuticals, Inc. Aminocaproic Acid Tablets USP, 500 mg 12/14/2020 No N/A N/A 63 Morphine Sulfate, NDA 022207 212451 Alkem Laboratories Morphine Sulfate Tablets, 15 mg and 30 mg 12/3/2020 Yes No 2/11/2021 62 Depen, NDA 019854 212933 Lupin Limited Penicillamine Tablets USP, 250 mg 11/30/2020 No N/A N/A 61 Alinia, NDA 021497 213820 Rising Pharma Holding, Inc. Nitazoxanide Tablets, 500 mg 11/27/2020 Yes No 12/7/2020 60 Kenalog, NDA 011600 213619 Cintex Services, LLC Triamcinolone Acetonide Ointment USP, 0.05% 11/10/2020 No N/A N/A 59 Parafon Forte DSC, NDA 011529 212743 Par Pharmaceutical, Inc. Chlorzoxazone Tablets USP, 750 mg 11/2/2020 No N/A N/A 58 Timoptic-XE, NDA 020330 212942 Alembic Pharmaceuticals Limited Timolol Maleate Ophthalmic Gel Forming Solution, 0.25% and 0.5% 10/22/2020 Yes No 11/25/2020 57 Librax, NDA 012750 213530 ECI Pharmaceuticals, LLC Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules USP, 5 mg/2.5 mg 10/20/2020 Yes No 10/26/2020 56 Kerydin, NDA 204427 211848 Perrigo Pharma International DAC Tavaborole Topical Solution, 5% 10/13/2020 No N/A N/A 55 Monurol, NDA 050717 212548 Xiromed Pharma Espana, S.L. Fosfomycin Tromethamine Granules for Oral Solution, 3 g (base) Single-Dose Packet 10/6/2020 Yes No 10/6/2020 54 Firazyr, NDA 022150 213054 Dr. Reddy’s Laboratories Limited Icatibant Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Pre-Filled Syringe 10/5/2020 No N/A N/A 53 Claritin RediTabs, NDA 021993 212795 Tenshi Kaizen Private Limited. Loratadine Orally Disintegrating Tablets USP, 5 mg 9/18/2020 Yes Yes N/A 52 Parafon Forte DSC, NDA 011529 212053 i3 Pharmaceuticals Chlorzoxazone Tablets USP, 375 mg and 750 mg 9/14/2020 No N/A N/A 51 Taclonex, NDA 22185 212367 Perrigo Calcipotriene and Betamethasone Dipropionate Topical Suspension, 0.005%/0.064% 9/11/2020 No N/A N/A 50 Nascobal, NDA 21642 212458 Perrigo Cyanocobalamin Nasal Solution 500 mcg/spray 9/9/2020 No N/A N/A 49 Daptomycin, NDA 208385 211403 Dr. Reddy’s Laboratories Inc. Daptomycin for Injection, 350 mg per vial (single-dose vial) 8/31/2020 No N/A N/A 48 Revatio, NDA 203109 213041 AptaPharma, Inc. Sildenafil for Oral Suspension, 10mg/mL 8/6/2020 No N/A N/A 47 Cuprimine, NDA 019853 211867 Dr Reddy’s Laboratories, Inc. Penicillamine Capsules USP, 250 mg 8/4/2020 No N/A N/A 46 Metro I.V., NDA 018900 212435 Gland Pharma Limited Metronidazole Injection USP, 500 mg/100 mL (5 mg/mL) 8/3/2020 Yes Yes N/A 45 Demser, NDA 017871 213734 Amneal Metyrosine Capsules USP, 250 mg 7/24/2020 Yes No 7/30/2020 44 Mexitil, NDA 018873 213500 CrossMedika SA Mexiletine Hydrochloride Capsules USP, 150 mg, 200 mg, and 250 mg 7/22/2020 Yes No 7/22/2020 43 Parafon Forte DSC, NDA 011529 212898 Teva Pharmaceuticals USA, Inc. Chlorzoxazone Tablets USP, 375 mg and 750 mg 6/17/2020 No N/A N/A 42 Albenza, NDA 020666 211636 Lupin Limited Albendazole Tablets USP, 200 mg 6/10/2020 Yes Yes N/A 41 Kenalog, NDA 011600 212356 Strides Pharma Inc. Triamcinolone Acetonide Ointment USP, 0.05% 6/1/2020 No N/A N/A 40 Revatio, NDA 203109 211534 Teva Pharmaceuticals USA, Inc. Sildenafil for Oral Suspension, 10 mg/mL 5/29/2020 No N/A N/A 39 Parafon Forte DSC, NDA 011529 212185 Glenmark Pharmaceuticals Limited Chlorzoxazone Tablets USP, 375 mg and 750 mg 5/26/2020 No N/A N/A 38 Bentyl, NDA 007961 212286 Hikma Pharmaceuticals USA Inc. Dicyclomine Hydrochloride Oral Solution USP, 10 mg/5 mL 5/22/2020 Yes No 5/22/2020 37 Migranal, NDA 020148 212907 Cipla Limited Dihydroergotamine Mesylate Nasal Spray, 4 mg/mL (1 mL Vial) 5/20/2020 Yes No 5/23/2020 36 K-Dur, NDA 019439 212861 Amneal Potassium Chloride Extended-Release Tablets USP, 15 mEq 5/8/2020 Yes Yes N/A 35 Butrans, NDA 021306 211586 Amneal Buprenorphine Transdermal System, 5 mcg/hour, 7.5 mcg/hour, 10 mcg/hour, 15 mcg/hour, and 20 mcg/hour 4/14/2020 Yes (7.5 mcg/hour); No (20 mcg/hour); No (15 mcg/hour); No (10 mcg/hour); No (5 mcg/hour) No 4/16/2020 34 Adrenalin, NDA 204640 211880 International Medication Systems, Limited Epinephrine Injection USP, 30 mg/30 mL (1 mg/mL) 4/24/2020 No N/A N/A 33 Narcan, NDA 16636 213209 Dr. Reddy’s Laboratories Limited Naloxone Hydrochloride Injection USP, 2 mg/2 mL (1 mg/mL) 3/16/2020 Yes No 3/18/2020 32 Tepadina, NDA 208264 213049 MSN Pharmaceuticals Inc. Thiotepa for Injection USP, 15mg/vial and 100 mg/vial 3/4/2020 No N/A N/A 31 Depen, NDA 19854 211497 Teva Pharmaceuticals USA, Inc. Penicillamine Tablets USP, 250mg 2/13/2020 Yes Yes N/A 30 Mestinon, NDA 15193 212702 Amneal Pyridostigmine Bromide Oral Syrup, USP 60 mg/5 mL 1/10/2020 No N/A N/A 29 Valium, NDA 016087 211998 Beloteca, Inc. Diazepam Injection USP, 50 mg/10 mL (5 mg/mL) 12/26/2019 Yes Yes N/A 28 Proglycem, NDA 017453 211050 e5 Pharma, LLC Diazoxide Oral Suspension USP, 50 mg/mL, 12/20/2019 Yes No 12/20/2019 27 Triamcinolone Acetonide, ANDA 089595 212384 Encube Triamcinolone Acetonide Ointment USP, 0.05% 11/29/2019 Yes No 12/2/2019 26 Amicar, NDA 15197 212492 Amneal Aminocaproic Acid Tablets USP, 500 mg 11/27/2019 Yes No 12/3/2019 25 Chlorzoxazone, ANDA 40861 212253 Novitium Pharma Chlorzoxazone Tablets USP, 375 mg and 750 mg 11/27/2019 Yes No 11/27/2019 24 Revatio, NDA 203109 212440 Alkem Laboratories Sildenafil for Oral Suspension, 10 mg/mL 11/27/2019 No N/A N/A 23 Revatio, NDA 203109 212883 Ajanta Pharma Sildenafil for Oral Suspension, 10 mg/mL 11/27/2019 No N/A N/A 22 Butalbital and Acetaminophen, ANDA 207313 213115 Granules Butalbital and Acetaminophen Capsules, 50 mg/300 mg 11/25/2019 Yes No 1/30/2020 21 Eryped, NDA 050207 211991 Par Pharmaceutical Inc. Erythromycin Ethylsuccinate for Oral Suspension USP, 200 mg /5 mL and 400 mg/ 5 mL 10/23/2019 Yes Yes (400 mg) 11/11/2019 (200 mg) 20 Rapamune, NDA 21083 211406 Apotex Sirolimus Oral Solution, 1 mg/mL 10/22/2019 No N/A N/A 19 Digoxin, NDA 21648 213000 Novitium Pharma Digoxin Oral Solution USP, 0.05 mg/mL 10/4/2019 Yes No 10/4/2019 18 Elidel, NDA 21302 211769 Glenmark Pimecrolimus Cream, 1% 8/29/2019 No N/A N/A 17 Orfadin, NDA 21232 211041 Novitium Pharma Nitisinone Capsules, 2 mg, 5 mg and 10 mg 8/26/2019 No N/A N/A 16 Amicar, NDA 15230 212780 Amneal Aminocaproic Acid Oral Solution USP, 0.25 g/mL 8/23/2019 Yes No 8/30/2019 15 Aleve PM, NDA 205352 211830 Apotex Naproxen Sodium and Diphenhydramine Hydrochloride Tablets, 220/25 mg 8/22/2019 Yes Yes N/A 14 Levocarnitine, NDA 19257 211676 Novitium Pharma Levocarnitine Sugar Free Oral Solution, 1 g/mL 8/14/2019 Yes No 10/16/2019 13 Daptomycin, NDA 208385 212667 Accord Daptomycin for Injection, 350 mg/vial 7/12/2019 Yes No 7/16/2019 12 Hemabate, NDA 17989 211941 Dr. Reddy’s Laboratories Carboprost Tromethamine Injection, 250 mcg/mL 7/2/2019 Yes No 7/2/2019 11 Cuprimine, NDA 19853 210976 Watson Penicillamine Capsule, 250 mg 6/24/2019 Yes No 6/25/2019 10 Revatio, NDA 203109 212260 Novitium Pharma Sildenafil Citrate for Oral Suspension, 10 mg/mL 5/31/2019 Yes No 5/31/2019 9 Navane, NDA 16584 211642 Novitium Pharma Thiothixene Capsules, 1 mg, 2 mg, 5 mg and 10 mg 4/5/2019 Yes No 4/5/2019 8 Methergine, NDA 06035 211455 Teva Methylergonovine Maleate Tablets, 0.2 mg 3/20/2019 No N/A N/A 7 Mestinon, NDA 15193 211694 Novitium Pharma Pyridostigmine Bromide Oral Syrup, 60 mg/5 mL 3/8/2019 Yes No 3/8/2019 6 Rapamune, NDA 21083 211040 Novitium Pharma Sirolimus Solution, 1 mg/mL 1/28/2019 No N/A N/A 5 Westcort, NDA 01872 211750 Glenmark Hydrocortisone Valerate Ointment, 0.2 % 12/14/2018 Yes No 1/17/2019 4 Levo-Dromoran, NDA 08720 211484 Virtus Levorphanol Tartrate Tablet, 2 mg 12/13/2018 Yes No 12/13/2018 3 Amphetamine, ANDA 200166 211139 Amneal Amphetamine Sulfate Tablet, 5 mg and 10 mg 9/26/2018 Yes No 9/27/2018 (5 mg) 10/1/2018 (10 mg) 2 Methergine, NDA 06035 211483 Amneal Methylergonovine Maleate Tablets, 0.2 mg 9/10/2018 Yes No 9/21/2018 1 Potassium Chloride, NDA 206814 211067 Apotex Potassium Chloride Oral Solution, 20 mEq/15 mL and 40 mEq/15 mL 8/8/2018 Yes No 8/29/2018 (20 mg) 9/7/2018 (40 mg)

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