450Tazorac NDA 21184214560Long Grove Pharmaceuticals LLCTazarotene Cream, 0.05%11/24/2025NoN/AN/A 449Diastat & Diastat AcuDial NDA 20648217468Navinta LLCDiazepam Rectal Gel Rectal Delivery System, 2.5 mg, 10 mg and 20 mg11/14/2025NoN/AN/A 448Omnipaque NDA 18956217737Amneal EU, LimitedIohexol Injection USP, 300 mg Iodine/mL Single-Dose Bottles11/13/2025Yes 447Vumerity NDA 211855218596Zydus Worldwide DMCCDiroximel Fumarate Delayed-Release Capsules, 231 mg11/12/2025NoN/AN/A 446Cipro HC NDA 20805218273Cosette Pharmaceuticals NC Laboratories LLCCiprofloxacin Hydrochloride and Hydrocortisone Otic Suspension, 0.2%/1%11/10/2025Yes 445Phytonadione NDA 083722216601Amneal EU, LimitedPhytonadione Injectable Emulsion USP, 1 mg/0.5 mL11/4/2025NoN/AN/A 444Atropine Sulfate NDA 214652214025Hikma Pharmaceuticals USA Inc.Atropine Sulfate Injection USP, 0.4 mg/mL and 1 mg/mL, Single-Dose Vials10/24/2025NoN/AN/A 443Premarin NDA 04782214023Novast Laboratories Ltd.Conjugated Estrogens Tablets USP, 0.9 mg and 1.25 mg10/15/2025YesNo10/17/2025 442Premarin NDA 04782214025Novast Laboratories Ltd.Conjugated Estrogens Tablets USP, 0.3 mg, 0.45 mg and 0.625 mg10/15/2025YesNo10/17/2025 441Thorazine NDA 09149216678Rubicon Research Private LimitedChlorpromazine Hydrochloride Oral Concentrate USP, 30 mg/mL and 100 mg/mL10/10/2025NoN/AN/A 440Vancomycin NDA 209481215324Steriscience Pte. LimitedVancomycin Hydrochloride for Injection USP, 750 mg/vial, 1.25 g/vial and 1.5 g/vial (Single-Dose Vials)10/2/2025NoN/AN/A 439Xarelto NDA 215859218195Lupin LimitedRivaroxaban for Oral Suspension, 1 mg/mL9/25/2025NoN/AN/A 438Lumigan NDA 022184217289Amneal EU, LimitedBimatoprost Ophthalmic Solution, 0.01%9/22/2025NoN/AN/A 437Endometrin NDA 022057218391Xiromed Pharma Espana, S.L.Progesterone Vaginal Insert, 100 mg9/19/2025YesN/A9/23/2025 436Glucagon NDA 020928218813Cipla LimitedGlucagon for Injection USP, 1 mg/vial packaged in an emergency kit9/15/2025YesNo10/20/2025 435Phytonadione ANDA 083722216444Alembic Pharmaceuticals Limited Phytonadione Injectable Emulsion USP, 1 mg/0.5 mL, Single-Dose Prefilled Syringe9/8/2025NoN/AN/A 434Votrient NDA 022465219922Torrent Pharmaceuticals LimitedPazopanib Tablets, 400 mg9/4/2025YesN/A11/7/2025 433Risperdal Consta NDA 021346218586Amneal EU, Limited.Risperidone for Extended-Release Injectable Suspension, 12.5 mg per vial, 25 mg per vial, 37.5 mg per vial, and 50 mg per vial, Single-Dose Vials9/2/2025Yes 37.5 mg/vial and 50 mg/vial - 11/10/2025 25 mg/vial - 11/13/2025 (by ANDA 211220) 432Risperdal Consta NDA 021346211220Nanomi BVRisperidone for Extended-Release Injectable Suspension, 25 mg per vial, 37.5 mg per vial, and 50 mg per vial, Single-Dose Vials9/2/2025YesN/A37.5 mg/vial and 50 mg/vial - 11/10/2025 25 mg/vial - 11/13/2025 431Benadryl NDA 006146219845Micro Labs USA, Inc.Diphenhydramine Hydrochloride Injection USP, 500 mg/10 mL (50 mg/mL), Multi-Dose Vial8/22/2025YesYesN/A 430Denavir NDA 020629214100Amneal Pharmaceuticals LLCPenciclovir Cream, 1%8/22/2025NoN/AN/A 429Abraxane NDA 021660217877Mylan Pharmaceuticals Inc.Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound), 100 mg/Vial, Single-Dose Vial8/19/2025NoN/AN/A 428Norepinephrine Bitartrate in 5% Dextrose NDA 214313219692Sagent PharmaceuticalsNorepinephrine Bitartrate in 5% Dextrose Injection, 4 mg/250 mL (16 mcg/mL) and 8 mg/250 mL (32 mcg/mL), Single-Dose Bags8/11/2025NoN/AN/A 427Emflaza NDA 208685216992Upsher-Smith Laboratories LLCDeflazacort Oral Suspension, 22.75 mg/mL8/11/2025NoN/AN/A 426Venofer NDA 021135212559Mylan Laboratories LimitedIron Sucrose Injection USP, 100 mg/5 mL (20 mg/mL) and 200 mg/10 mL (20 mg/mL), Single-Dose Vials8/8/2025YesNo8/11/2025 425Venofer NDA 021135208977International Medication Systems, LimitedIron Sucrose Injection USP, 50 mg/2.5 mL (20 mg/mL), 100 mg/5 mL (20 mg/mL), and 200 mg/10 mL (20 mg/mL), Single-Dose Vials8/8/2025Yes50 mg/2.5 mL: No100 mg/5 mL and 200 mg/10 mL: 8/11/2025 (by ANDA 212559) 50 mg/2.5 mL: 8/12/2025 424Motegrity NDA 210166218056Zydus Pharmaceuticals (USA) Inc.Prucalopride Tablets, 1 mg and 2 mg8/7/2025NoN/AN/A 423Alphagan P NDA 021770217599Upsher-Smith Laboratories, LLCBrimonidine Tartrate Ophthalmic Solution, 0.1%7/30/2025NoN/AN/A 422Victoza NDA 022341215421Lupin LimitedLiraglutide Injection, 18 mg/3 mL (6 mg/mL), Single-Patient-Use Prefilled Pen7/22/2025NoN/AN/A 421Selenious Acid NDA 209379218661Cipla LimitedSelenious Acid Injection USP, 600 mcg/10 mL (60 mcg/mL), Pharmacy Bulk Package and 12 mcg/2 mL (6 mcg/mL), Single-Dose Vial7/21/2025NoN/AN/A 420Sertraline Hydrochloride NDA 215133218853Zenara Pharma Private LimitedSertraline Hydrochloride Capsules, 150 mg and 200 mg7/16/2025YesNo7/22/2025 419Selenious Acid NDA 209379219629Gland Pharma LimitedSelenious Acid Injection USP, 600 mcg/10 mL (60 mcg/mL), Pharmacy Bulk Package7/8/2025NoN/AN/A 418Manganese Chloride NDA 018962217583Fresenius Kabi USA, LLCManganese Chloride Injection USP, 1 mg/10 mL (0.1 mg/mL), Single-Dose Vial7/7/2025YesYesN/A 417Indocin NDA 017814216905Annora Pharma Private LimitedIndomethacin Suppositories USP, 50 mg7/3/2025NoN/AN/A 416Lotemax SM NDA 208219218087Lupin LimitedLoteprednol Etabonate Ophthalmic Gel, 0.38%6/30/2025NoN/AN/A 415AmBisome NDA 050740212967Mylan Laboratories LimitedAmphotericin B Liposome for Injection, 50 mg per vial, Single-Dose Vial6/30/2025NoN/AN/A 414Motegrity NDA 210166217662Hikma Pharmaceuticals USA Inc.Prucalopride Tablets, 1 mg and 2 mg6/24/2025NoN/AN/A 413Motegrity NDA 210166219216H2-Pharma, LLCPrucalopride Tablets, 1 mg and 2 mg6/24/2025NoN/AN/A 412Motegrity NDA 210166218795Zenara Pharma Private LimitedPrucalopride Tablets, 1 mg and 2 mg6/24/2025NoN/AN/A 411Motegrity NDA 210166219078Somerset Therapeutics, LLCPrucalopride Tablets, 1 mg and 2 mg6/24/2025NoN/AN/A 410Motegrity NDA 210166218177MSN Laboratories Private LimitedPrucalopride Tablets, 1 mg and 2 mg6/24/2025NoN/AN/A 409Motegrity NDA 210166218295Alkem Laboratories LimitedPrucalopride Tablets, 1 mg and 2 mg6/24/2025NoN/AN/A 408Motegrity NDA 210166218977Apotex Inc.Prucalopride Tablets, 1 mg and 2 mg6/24/2025NoN/AN/A 407Motegrity NDA 210166218847Lupin Limited Prucalopride Tablets, 1 mg and 2 mg6/24/2025NoN/AN/A 406Motegrity NDA 210166218778Torrent Pharmaceuticals LimitedPrucalopride Tablets, 1 mg and 2 mg6/24/2025NoN/AN/A 405Motegrity NDA 210166218963Appco Pharma LLCPrucalopride Tablets, 1 mg and 2 mg6/24/2025NoN/AN/A 404Motegrity NDA 210166218812SKG Pharma Inc. Prucalopride Tablets, 1 mg and 2 mg6/24/2025NoN/AN/A 403Ablysinol NDA 207987219400XGen Pharmaceuticals DJB, Inc.Dehydrated Alcohol Injection USP, 99%, Single-Dose Ampule6/23/2025NoN/AN/A 402Ablysinol NDA 207987219444Breckenridge Pharmaceutical, Inc.Dehydrated Alcohol Injection USP, 5 mL of ≥ 99% by volume ethyl alcohol, Single-Dose Vial6/23/2025NoN/AN/A 401Ablysinol NDA 207987217845Accord Healthcare Inc.Dehydrated Alcohol Injection USP, 5 mL of ≥ 99% by volume ethyl alcohol, Single-Dose Vial6/23/2025NoN/AN/A 400Hicon NDA 021305213615Cardinal Health 414, LLCSodium Iodide I 131 Solution USP, 250-1000 mCi6/12/2025YesYesN/A 399Selenious Acid NDA 209379219633Aspiro Pharma LimitedSelenious Acid Injection USP, 12 mcg/2 mL (6 mcg/mL) Single-Dose Vial and 600 mcg/10 mL (60 mcg/mL), Pharmacy Bulk Package6/11/2025NoN/AN/A 398Pred Forte NDA 017011218256Amneal EU, LimitedPrednisolone Acetate Ophthalmic Suspension USP, 1%6/11/2025NoN/AN/A 397Zinc Sulfate NDA 209377217624Stira Pharmaceuticals LLCZinc Sulfate Injection USP, 10 mg/10 mL (1 mg/mL), Pharmacy Bulk Package6/10/2025NoN/AN/A 396Prexxartan NDA 209139216460Rubicon Research Private LimitedValsartan Oral Solution, 20 mg/5 mL (4 mg/mL)6/5/2025NoN/AN/A 395Magnesium Sulfate NDA 019316219777Aspiro Pharma LimitedMagnesium Sulfate Injection USP, 1 g/2 mL (500 mg/mL) and 25 g/50 mL (500 mg/mL), Single-Dose Vials5/28/2025YesNo8/5/2025 394Topamax NDA 020844216683Rubicon Research Private LimitedTopiramate Capsules USP, 50 mg5/27/2025YesNo8/5/2025 393Amicar NDA 015230213216Apozeal Pharmaceuticals Inc.Aminocaproic Acid Oral Solution USP, 0.25 g/mL5/19/2025NoN/AN/A 392Isentress HD NDA 022145217990Lupin LimitedRaltegravir Tablets USP, 600 mg5/6/2025NoN/AN/A 391Zovirax NDA 021478212981Cipla LimitedAcyclovir Cream, 5%5/2/2025NoN/AN/A 390Vuity NDA 214028217733Amneal EU, LimitedPilocarpine Hydrochloride Ophthalmic Solution USP, 1.25%4/28/2025NoN/AN/A 389Nexium NDA 021957218948Aurobindo Pharma LimitedEsomeprazole Magnesium for Delayed-Release Oral Suspension, 5 mg4/15/2025NoN/AN/A 388Nitroglycerin ANDA 087355218235Encube Ethicals, Inc.Nitroglycerin Ointment USP, 2%4/15/2025YesYesN/A 387Zinc Chloride NDA 018959217625Stira Pharmaceuticals LLCZinc Chloride Injection USP, 10 mg/10 mL (1 mg/mL), Single-Dose Vial4/14/2025NoN/AN/A 386Carafate NDA 019183211780Padagis US LLCSucralfate Oral Suspension, 1 g/10 mL4/14/2025NoN/AN/A 385Durezol NDA 022212212566Mylan Laboratories LimitedDifluprednate Ophthalmic Emulsion, 0.05%3/20/2025NoN/AN/A 384Entadfi NDA 215423218499Novitium Pharma LLCFinasteride and Tadalafil Capsules, 5 mg/5 mg3/19/2025NoN/AN/A 383Emflaza NDA 208684217741Sun Pharmaceutical Industries, Inc.Deflazacort Tablets, 6 mg, 18 mg, 30 mg and 36 mg3/18/2025NoN/AN/A 382Erleada NDA 210951217113Zydus Pharmaceuticals (USA) Inc.Apalutamide Tablets, 60 mg3/17/2025NoN/AN/A 381Chronulac NDA 017884217914PAI Holdings, LLCLactulose for Oral Solution, 10 g/packet and 20 g/packet3/14/2025Yes No3/17/2025 380Buspar NDA 021190218628Epic Pharma, LLCBuspirone Hydrochloride Capsules, 7.5 mg, 10 mg, and 15 mg3/13/2025Yes YesN/A 379Kenalog-10 NDA 012041218773Dr. Reddy’s Laboratories LimitedTriamcinolone Acetonide Injectable Suspension USP, 50 mg/5 mL (10 mg/mL), Multiple-Dose Vial3/12/2025Yes YesN/A 378Halaven NDA 201532218743Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Eribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL), Single-Dose Vial3/4/2025NoN/AN/A 377Sprycel NDA 021986218719Zydus Pharmaceuticals (USA) Inc.Dasatinib Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg and 140 mg3/3/2025NoN/AN/A 376Sprycel NDA 021986213383Dr. Reddy’s Laboratories LimitedDasatinib Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg, and 140 mg3/3/2025NoN/AN/A 375Purixan NDA 205919216418Hikma Pharmaceuticals USA, Inc.Mercaptopurine Oral Suspension, 2,000 mg/100 mL (20 mg/mL)2/26/2025YesNo2/26/2025 374Lucemyra NDA 209229218699MSN Laboratories Private Limited Lofexidine Tablets, 0.18 mg2/24/2025NoN/AN/A 373Indocin NDA 017814215399Amneal Pharmaceuticals LLCIndomethacin Suppositories USP, 50 mg2/24/2025NoN/AN/A 372Biorphen NDA 212909215617Somerset Therapeutics LLCPhenylephrine Hydrochloride Injection USP, 500 mcg/5 mL (100 mcg/mL), Single-Dose Ampule2/14/2025YesYesN/A 371Selenious Acid NDA 209379218779Fresenius Kabi USA, LLCSelenious Acid Injection USP, 600 mcg/10 mL (60 mcg/mL), Pharmacy Bulk Package2/10/2025NoN/AN/A 370Epinephrine NDA 205029219239Syneos Health, LLC Epinephrine Injection USP, 10 mg/10 mL (1 mg/mL), Multiple-Dose Vial2/6/2025YesNo3/7/2025 369Revlimid NDA 021880216213Amneal EU, LimitedLenalidomide Capsules, 2.5 mg and 20 mg1/31/2025NoN/AN/A 368Potassium Phosphates NDA 212832217892Cipla LimitedPotassium 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) Single-Dose Vials; phosphorus 150 mmol/50 mL (3 mmol/mL) and potassium 220 mEq/50 mL (4.4 mEq/mL) Pharmacy Bulk Package1/24/2025NoN/AN/A 367ProvayBlue NDA 204630217380Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.Methylene Blue Injection USP, 50 mg/10 mL (5 mg/mL), Single-Dose Vial1/23/2025No N/AN/A 366Stromectol NDA 050742215922Rubicon Research Private LimitedIvermectin Tablets USP, 6 mg1/22/2025YesNo4/4/2025 365Mesnex NDA 020855218871Ricon Pharma LLCMesna Tablets USP, 400 mg1/13/2025YesNo1/14/2025 364Nexium NDA 021957217714Cipla LimitedEsomeprazole Magnesium for Delayed-Release Oral Suspension, 2.5 mg and 5 mg1/7/2025NoN/AN/A 363Phytonadione ANDA 83722214966Cipla LimitedPhytonadione Injectable Emulsion USP, 1 mg/0.5 mL, Single-Dose Prefilled Syringe1/3/2025YesNo3/10/2025 362Tham NDA 013025213116Milla Pharmaceuticals, IncTromethamine Injection, 3.6 g/100 mL in 500 mL, Single-Dose Container12/31/2024YesNo1/2/2025 361Motegrity NDA 210166218492Novitium Pharma LLCPrucalopride Tablets, 1 mg and 2 mg12/26/2024YesNo12/26/2024 360Tetracaine Hydrochloride NDA 210821217227Somerset Therapeutics LLCTetracaine Hydrochloride Ophthalmic Solution USP, 0.5%12/20/2024YesNo12/27/2024 359ProvayBlue NDA 204630216959RK Pharma Inc.Methylene Blue Injection USP, 50 mg/10 mL (5 mg/mL)12/17/2024NoN/AN/A 358Rectiv NDA 021359216452Encube Ethicals Private LimitedNitroglycerin Ointment USP, 0.4%12/16/2024NoN/AN/A 357Alrex NDA 020803216345Amneal EU, LimitedLoteprednol Etabonate Ophthalmic Suspension, 0.2%12/13/2024NoN/AN/A 356Ozobax NDA 208193214445Rubicon Research Private LimitedBaclofen Oral Solution, 5 mg/5 mL12/6/2024NoN/AN/A 355Miacalcin NDA 017808212675Fresenius Kabi USA, LLCCalcitonin Salmon Injection USP, 400 I.U. per 2 mL (200 I.U. per mL), Multi-Dose Vial12/5/2024NoN/AN/A 354Abilify NDA 202971216608Mylan Pharmaceuticals, Inc.Aripiprazole for Extended-Release Injectable Suspension, 300 mg/vial and 400 mg/vial, Single-Dose Vials12/3/2024NoN/AN/A 353Atropine Sulfate NDA 209260215005Somerset Therapeutics LLCAtropine Sulfate Injection USP, 8 mg/20 mL (0.4 mg/mL), Multiple-Dose Vial11/29/2024NoN/AN/A 352Rectiv NDA 021359212222Acrux DDS Pty LtdNitroglycerin Ointment USP, 0.4%11/29/2024NoN/AN/A 351Provayblue NDA 204630216955Steriscience Pte. LimitedMethylene Blue Injection USP, 50 mg/10 mL (5 mg/mL), Single-Dose Ampule11/22/2024NoN/AN/A 350Provayblue NDA 204630217561Nexus Pharmaceuticals LLCMethylene Blue Injection USP, 50 mg/10 mL (5 mg/mL), Single-Dose Vial11/21/2024NoN/AN/A 349Indocin NDA 017814215899Hikma Pharmaceuticals USA, Inc.Indomethacin Suppositories USP, 50 mg11/19/2024NoN/AN/A 348Chromic Chloride in Plastic Container NDA 018961218538RK Pharma Inc.Chromic Chloride Injection USP, 40 mcg/10 mL (4 mcg/mL), Single-Dose Vial11/18/2024YesYesN/A 347Clomid NDA 016131216545Rubicon Research Private LimitedClomiphene Citrate Tablets USP, 50 mg11/12/2024NoN/AN/A 346Clomid NDA 016131216739Appco Pharma LLCClomiphene Citrate Tablets USP, 50 mg11/8/2024YesNo11/19/2024 345Cetraxal NDA 021918217887IdentiRx, LLCCiprofloxacin Otic Solution, 0.2%, Single-Dose Vial11/5/2024YesNo12/13/2024 344Emflaza NDA 208684216720Upsher-Smith Laboratories, LLCDeflazacort Tablets, 6 mg, 18 mg, 30 mg, and 36 mg11/5/2024NoN/AN/A 343Radicava NDA 209176217565XGen Pharmaceuticals DJB Inc.Edaravone Injection, 30 mg/100 mL (0.3 mg/mL) and 60 mg/100 mL (0.6 mg/mL), Single-Dose Vials10/31/2024NoN/AN/A 342Eprontia NDA 214679217795Alkem Laboratories LimitedTopiramate Oral Solution, 25 mg/mL10/31/2024NoN/AN/A 341Nicardipine Hydrochloride NDA 022276215406Amneal EU, LimitedNicardipine Hydrochloride Injection USP, 25 mg/10 mL (2.5 mg/mL), Single-Dose Vial10/31/2024YesYesN/A 340Cyclophosphamide NDA 212501216783Nexus Pharmaceuticals LLCCyclophosphamide Injection, 500 mg/2.5 mL (200 mg/mL) and 1 gram/5 mL (200 mg/mL), Multiple-Dose Vials10/29/2024NoN/AN/A 339Estrogel NDA 021166217882Novitium Pharma LLCEstradiol Gel, 0.06%10/23/2024NoN/AN/A 338Zinc Chloride NDA 018959216152Somerset Therapeutics LLCZinc Chloride Injection USP, 10 mg/10 mL (1 mg/mL), Single-Dose Vial10/16/2024YesNo10/16/2024 337Akovaz NDA 208289217721Hikma Pharmaceuticals USA, Inc.Ephedrine Sulfate Injection USP, 25 mg/5 mL (5 mg/mL), Single-Dose Prefilled Syringe10/11/2024YesNo12/20/2024 336Brevital Sodium NDA 011559215488Steriscience Pte. LimitedMethohexital Sodium for Injection USP, 500 mg/vial10/3/2024YesNo12/12/2024 335Chantix NDA 021928215931Dr. Reddy’s Laboratories LimitedVarenicline Tablets, 0.5 mg and 1 mg10/1/2024NoN/AN/A 334Keflet NDA 050440218947Alkem Laboratories LimitedCephalexin Tablets USP, 250 mg and 500 mg9/27/2024Yes 10/11/2024 (by ANDA 218817) 333Keflet NDA 050440218817Aurobindo Pharma LimitedCephalexin Tablets USP, 250 mg and 500 mg9/27/2024YesNo10/11/2024 332Denavir NDA 020629212368Padagis Israel Pharmaceuticals LTDPenciclovir Cream, 1%9/27/2024NoN/AN/A 331Dexmedetomidine NDA 206628218112Somerset Therapeutics LLCDexmedetomidine Injection USP, 400 mcg/4 mL (100 mcg/mL) and 1000 mcg/10 mL (100 mcg/mL), Multi-dose Vials9/24/2024YesNo10/1/2024 330Nicardipine in Sodium Chloride NDA 22276215592Cipla LimitedNicardipine Hydrochloride in 0.9% Sodium Chloride Injection, 20 mg/200 mL (0.1 mg/mL) and 40 mg/200 mL (0.2 mg/mL), Single-dose Containers9/24/2024YesNo11/22/2024 329Miacalcin NDA 017808213766Cipla LimitedCalcitonin Salmon Injection USP, 200 I.U. per mL (400 I.U. per 2 mL), Multi-Dose Vial9/20/2024NoN/AN/A 328Nubain NDA 18024216049Somerset Therapeutics LLCNalbuphine Hydrochloride Injection, 100 mg/10mL (10 mg/mL) and 200 mg/10 mL (20 mg/mL), Multiple-dose Vials9/19/2024YesNo10/1/2024 327Nubain NDA 18024216050Somerset Therapeutics LLCNalbuphine Hydrochloride Injection, 10 mg/mL and 20 mg/mL, Single-dose Ampules9/19/2024YesNo9/25/2024 326Theo-Dur NDA 85328215312Strides Pharma Global Pte LimitedTheophylline Extended-Release Tablets, 300 mg and 450 mg9/5/2024Yes - 300 mg No - 450 mgNo9/27/2024 325Solu-Cortef NDA 09866214050Cipla LimitedHydrocortisone Sodium Succinate Injection USP, 100 mg/vial, Single-Dose Vial9/5/2024YesNo9/26/2024 324Gocovri NDA 208944214897Zydus Worldwide DMCCAmantidine Extended-release Capsules, 68.5 mg8/26/2024NoN/AN/A 323Advil Dual Action with Acetaminophen NDA 211733218247Dr. Reddy’s Laboratories LimitedAcetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC)8/23/2024NoN/AN/A 322Asacol HD NDA 21830213191Teva Pharmaceuticals Inc.Mesalamine Delayed-release Tablets USP, 800 mg8/22/2024YesNo8/22/2024 321Lucemyra NDA 209229218613Indoco Remedies LimitedLofexidine Tablets, 0.18 mg8/20/2024YesNo8/28/2024 320ERY-TAB ANDA 062298211975Torrent Pharma Inc.Erythromycin Delayed-Release Tablets USP, 333 mg8/13/2024YesNo10/24/2024 319Ingrezza NDA 209241216137Zydus Worldwide DMCCValbenazine Capsules, 40 mg, 60 mg and 80 mg8/7/2024NoN/AN/A 318Pred Forte NDA 17011216935Lupin LimitedPrednisolone Acetate Ophthalmic Suspension USP, 1%8/2/2024YesNo10/11/2024 317Carafate NDA 19183212769Hikma Pharmaceuticals USA Inc.Sucralfate Oral Suspension, 1 g/10 mL7/23/2024NoN/AN/A 316Thiola EC NDA 211843216456Teva Pharmaceuticals Inc.Tiopronin Delayed-Release Tablets, 100 mg and 300 mg7/22/2024NoN/AN/A 315Halaven 201532214850Long Grove Pharmaceuticals LLCEribulin Mesylate Injection, 1 mg/2 mL (0.5 mg/mL), Single-dose Vial7/18/2024NoN/AN/A 314Zinc Sulfate NDA 209377216135Somerset Therapeutics LLCZinc Sulfate Injection USP, 30 mg/10 mL (3 mg/mL) and 25 mg/5 mL (5 mg/mL), Pharmacy Bulk Package7/17/2024NoN/AN/A 313Tazorac NDA 21184217075Padagis Israel Pharmaceuticals Ltd.Tazarotene Cream, 0.05%7/15/2024YesNo9/9/2024 312Divigel NDA 022038216055Amneal Pharmaceuticals LLCEstradiol Gel, 0.1% (0.25 mg, 0.5 mg, 0.75 mg, 1 mg, and 1.25 mg per Packet)7/12/2024NoN/AN/A 311Potassium Phosphates NDA 212832217726Somerset Therapeutics LLCPotassium 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), Single-Dose Vials7/11/2024NoN/AN/A 310Alrex NDA 20803215203Padagis US LLCLoteprednol Etabonate Ophthalmic Suspension, 0.2%7/10/2024NoN/AN/A 309Endari NDA 208587215647Novitium Pharma LLCL-Glutamine Oral Powder, 5 grams/packet7/8/2024NoN/AN/A 308Zinc Sulfate NDA 209377214597Nivagen Pharmaceuticals, IncZinc 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 Package7/5/2024NoN/AN/A 307Atropine Sulfate NDA 214652215969Somerset Therapeutics LLCAtropine Sulfate Injection USP, 0.4 mg/mL and 1 mg/mL, Single-Dose Vials7/3/2024NoN/AN/A 306Exparel NDA 22496214348Jiangsu 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

7/1/2024NoN/AN/A 305Atropine Sulfate NDA 206289215618Somerset Therapeutics LLCAtropine Sulfate Ophthalmic Solution USP, 1%7/1/2024NoN/AN/A 304Astepro OTC NDA 213872216576Amneal Pharmaceuticals LLCAzelastine Hydrochloride Nasal Spray, 0.15% (205.5 mcg per spray)(OTC/Allergy)6/5/2024NoN/AN/A 303Astepro OTC NDA 213872216421Apotex Inc.Azelastine Hydrochloride Nasal Spray, 0.15% (205.5 mcg per spray)(OTC/Allergy and Children’s Allergy)5/29/2024NoN/AN/A 302Halog 17823217671Encube Ethicals Private LimitedHalcinonide Topical Solution USP, 0.1%5/29/2024YesYesN/A 301Phenylephrine NDA 207926215183Caplin Steriles LimitedPhenylephrine Hydrochloride Ophthalmic Solution USP, 2.5% and 10% 5/23/2024NoN/AN/A 300Timolol Maleate NDA 20963216343Amneal EU, LimitedTimolol Maleate Ophthalmic Gel Forming Solution, 0.25% and 0.5%5/23/2024YesYesN/A 299Somatuline Depot NDA 22074217193InvaGen Pharmaceuticals, Inc.Lanreotide Injection, 60 mg/0.2 mL, 90 mg/0.3 mL, 120 mg/0.5 mL, Single-Dose Prefilled Syringes5/21/2024NoN/AN/A 298ProAir HFA NDA 21457212447Armstrong Pharmaceuticals Inc.Albuterol Sulfate Inhalation Aerosol, 90 mcg (base) per actuation5/21/2024NoN/AN/A 297Calcium Gluconate in Sodium Chloride NDA 208418216611Amneal EU, LimitedCalcium 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)5/10/2024NoN/AN/A 296Zegerid OTC NDA 22283217784Dr. Reddy’s Laboratories LimitedOmeprazole and Sodium Bicarbonate Powder for Oral Suspension, 20 mg/1680 mg (OTC)5/9/2024YesYesN/A 295Dexamethasone NDA 88306216284Zydus Pharmaceuticals (USA) Inc.Dexamethasone Tablets USP, 1 mg5/9/2024NoN/AN/A 294Vasostrict NDA 204485213988Dr. Reddy’s Laboratories LimitedVasopressin Injection USP, 20 Units/mL, Single-Dose Vials5/8/2024NoN/AN/A 293Radicava NDA 209176218354Long Grove Pharmaceuticals LLCEdaravone Injection, 30 mg/100 ml (0.3 mg/mL), Single-Dose Bag5/6/2024NoN/AN/A 292Radicava NDA 209176215917Dr. Reddy’s Laboratories LimitedEdaravone Injection, 60 mg/100 ml (0.6 mg/mL), Single-Dose Bag5/6/2024NoN/AN/A 291Cupric Chloride in Plastic Container NDA 18960217626Stira Pharmaceuticals LLCCupric Chloride Injection USP, 4 mg/10 mL (0.4 mg/mL), Single-Dose Vial4/30/2024Yes 6/24/2024 (by ANDA 216113) 290Cupric Chloride in Plastic Container NDA 18960216113Somerset TherapeuticsCupric Chloride Injection USP, 4 mg/10 mL (0.4 mg/mL), Single-Dose Vial4/30/2024YesNo6/24/2024 289Isopto Atropine NDA 208151217791Somerset TherapeuticsAtropine Sulfate Ophthalmic Solution USP, 1%4/29/2024YesNo6/7/2024 288Nasonex NDA 215712217438Apotex Inc.Mometasone Furoate Nasal Spray, 50 mcg/spray (OTC)4/23/2024NoN/AN/A 287Votrient NDA 22465218231Novugen Oncology Sdn. Bhd.Pazopanib Tablets, 200 mg4/23/2024NoN/AN/A 286EstroGel NDA 21166216160Solaris Pharma CorporationEstradiol Gel, 0.06%4/22/2024YesNo4/26/2024 285Tranexamic Acid NDA 212020216877Nexus Pharmaceuticals LLCTranexamic Acid in 0.7% Sodium Chloride Injection, 1,000 mg/100 mL (10 mg/mL)4/16/2024NoN/AN/A 284Miacalcin NDA 017808215715Dr. Reddy’s Laboratories LimitedCalcitonin Salmon Injection USP, 200 I.U. per mL (400 I.U. per 2 mL), Multi-Dose Vial4/11/2024NoN/AN/A 283Oracea NDA 218034218034Dr. Reddy’s Laboratories LimitedDoxycycline Capsules, 40 mg4/8/2024NoN/AN/A 282Narcan NDA 16636213573Fresenius Kabi USA, LLCNaloxone Hydrochloride Injection USP, 0.4 mg/mL and 1 mg/mL, Single-Dose Prefilled Syringes4/2/2024NoN/AN/A 281Sodium Acetate NDA 18893216920Hikma Pharmaceuticals USA, IncSodium Acetate Injection USP, 40 mEq/20 mL (2 mEq/mL)3/15/2024YesNo5/20/2024 280Entadfi NDA 215423218232Zydus Worldwide DMCCFinasteride and Tadalafil Capsules, 5 mg/5 mg3/15/2024YesYesN/A 279Rectiv NDA 21359216103Cosette Pharmaceuticals, IncNitroglycerin Ointment USP, 0.4%2/16/2024YesNo2/23/2024 278Lumify NDA 208144216361Dr. Reddy’s Laboratories SABrimonidine Tartrate Ophthalmic Solution, 0.025%2/16/2024NoN/AN/A 277Dilaudid NDA 019034216899Hikma Pharmaceuticals USA, IncHydromorphone Hydrochloride Injection USP, 0.2 mg/mL, Single-Dose Prefilled Syringe2/9/2024NoN/AN/A 276Dexamethasone ANDA 087916216283Zydus Pharmaceuticals (USA) IncDexamethasone Tablets USP, 2 mg2/7/2024NoN/AN/A 275Thiola EC NDA 211843216990Torrent Pharmaceuticals LtdTiopronin Delayed-Release Tablets, 100 mg and 300 mg1/30/2024NoN/AN/A 274Astagraf XL NDA 204096215012Chengdu Suncadia Medicine Co., LimitedTacrolimus Extended-Release Capsules, 0.5 mg, 1 mg, and 5 mg1/25/2024NoN/AN/A 273Carafate NDA 019183213549PD Partners III, LLCSucralfate Oral Suspension, 1 g/10 mL1/17/2024NoN/AN/A 272BiDil NDA 020727215988i3 Pharmaceuticals, LLCIsosorbide Dinitrate and Hydralazine Hydrochloride Tablets, 20 mg/37.5 mg1/17/2024NoN/AN/A 271Nuplazid NDA 210793214493Zydus Pharmaceuticals (USA) Inc.Pimavanserin Capsules, 34 mg1/16/2024NoN/AN/A 270Nuplazid NDA 207318214502Zydus Pharmaceuticals (USA) Inc.Pimavanserin Tablets, 10 mg1/16/2024NoN/AN/A 269Indocin NDA 018332217883Novitium Pharma LLCIndomethacin Oral Suspension, USP 25 mg/5 mL1/12/2024YesNo1/12/2024 268FML NDA 016851216348Amneal EU, LimitedFluorometholone Ophthalmic Suspension USP, 0.1%1/9/2024YesNo1/9/2024 267Amicar NDA 015230213213Sunny Pharmtech Inc.Aminocaproic Acid Oral Solution USP, 0.25 grams/mL12/27/2023NoN/AN/A 266Alrex NDA 020803215550Lupin LimitedLoteprednol Etabonate Ophthalmic Suspension, 0.2%12/26/2023NoN/AN/A 265Prezista NDA 021976214085Zydus Pharmaceuticals (USA) Inc.Darunavir Tablets, 800 mg12/13/2023NoN/AN/A 264ProvayBlue NDA 204630215636Zydus Pharmaceuticals (USA) Inc.Methylene Blue Injection USP, 10 mg/2 mL (5 mg/mL) and 50 mg/10 mL (5 mg/mL), Single-Dose Vials12/5/2023NoN/AN/A 263Lotemax NDA 202872213956Slayback Pharma LLCLoteprednol Etabonate Ophthalmic Gel, 0.5%11/29/2023NoN/AN/A 262Foscavir NDA 020068213987Beijing Sciecure Pharmaceutical Co., Ltd.Foscarnet Sodium Injection, 6000 mg/250 mL (24 mg/mL), Single-Dose Bottle for Infusion11/29/2023NoN/AN/A 261Corlanor NDA 206143213442Zydus Pharmaceuticals (USA) Inc. Ivabradine Tablets, 5 mg and 7.5 mg11/29/2023NoN/AN/A 260Condylox NDA 020529211871Padagis US LLCPodofilox Gel 0.5%11/22/2023YesNo12/13/2023 259Zovirax NDA 021478212361Alembic Pharmaceuticals LimitedAcyclovir Cream, 5%11/21/2023YesNo12/15/2023 258Revex NDA 020459216007Chengdu Shuode Pharmaceutical Co., LtdNalmefene Hydrochloride Injection, 100 mcg/mL and 2 mg/2 mL (1 mg/mL), Single-Dose Vials11/15/2023NoN/AN/A 257Divigel NDA 022038216524Padagis Israel Pharmaceuticals LtdEstradiol Gel, 0.1% (0.25 mg, 0.5 mg, 0.75 mg, 1 mg, and 1.25 mg per Packet)11/14/2023NoN/AN/A 256AN Sulfur Colloid NDA 017858213516Jubilant DraxImage IncKit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection11/9/2023YesNo12/4/2023 255Efudex NDA 016831215612Encube Ethicals Private LimitedFluorouracil Topical Solution USP, 5%11/2/2023YesYesN/A 254Aczone NDA 207154212657Padagis US LLCDapsone Gel, 7.5%11/1/2023NoN/AN/A 253Principen NDA 050056216554Aurobindo PharmaAmpicillin Capsules USP, 250 mg and 500 mg10/31/2023YesNo12/6/2023 252Calcium Gluconate in Sodium ChlorideNDA 208418217689Somerset TherapeuticsCalcium 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)10/19/2023Yes- 5,000 mg/50 mL (100 mg/mL); No-10,000 mg/100 mL (100 mg/mL)No10/20/2023 251Votrient NDA 022465215837Sun Pharmaceutical IndustriesPazopanib Tablets, 200 mg10/19/2023NoN/AN/A 250Votrient NDA 022465217517Teva PharmaceuticalsPazopanib Tablets, 200 mg10/19/2023NoN/AN/A 249Tranexamic Acid NDA 212020217155Amneal Pharmaceuticals of New York, LLC Tranexamic Acid in 0.7% Sodium Chloride Injection, 1,000 mg/100 mL (10 mg/mL)10/16/2023YesNo10/19/2023 248Potassium Phosphates NDA 212832216344Amneal 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), Pharmacy Bulk Package Vials10/10/2023NoN/AN/A 247Bridion NDA 022225214290Zydus Pharmaceuticals (USA) Inc.Sugammadex Injection, 200 mg/2 mL (100 mg/mL) and 500 mg/5 mL (100 mg/mL), Single-Dose Vials10/4/2023NoN/AN/A 246Glucotrol NDA 017783214874Rubicon Research Private LimitedGlipizide Tablets USP, 2.5 mg10/3/2023YesNo10/18/2023 245Potassium Phosphates NDA 212832216274American 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), Pharmacy Bulk Package Vials10/2/2023YesNo10/16/2023 - 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 244Xeljanz NDA 213082216878Slayback Pharma LLCTofacitinib Oral Solution, 1 mg/mL9/25/2023NoN/AN/A 243AK-FLUOR, 10% and 25% NDA 022186215709Nexus Pharmaceuticals Inc. Fluorescein Injection USP, 500 mg/5 mL (100 mg/mL) and 500 mg/2 mL (250 mg/mL), Single-Dose Vials9/25/2023Yes500 mg/5 mL (100 mg/mL): No 500 mg/2 mL (250 mg/mL): Yes500 mg/5 mL (100 mg/mL): 10/24/2023 500 mg/2 mL (250 mg/mL): N/A 242Ortho Evra NDA 21180214594Zydus Noveltech Inc.Norelgestromin and Ethinyl Estradiol Transdermal System, 150 mcg/35 mcg per day9/14/2023NoN/AN/A 241Gadavist NDA 201277216081Jiangsu Hengrui Pharmaceuticals Co., Ltd.Gadobutrol Injection, 30 mmol/30 mL (1 mmol/mL) and 65 mmol/65 mL (1 mmol/mL), Imaging Bulk Package 9/8/2023YesNo11/1/2023 240Calcium Gluconate in Sodium Chloride NDA 208418217174Amneal Pharmaceuticals LLCCalcium Gluconate in Sodium Chloride Injection, 1000 mg/50 mL and 2000 mg/100 mL (20 mg/mL), Single-Dose Containers9/5/2023YesNo9/12/2023 239Vyvanse NDA 021977215330Rhodes Pharmaceuticals L.P.Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg8/25/2023NoN/AN/A 238Combigan NDA 021398215230Syneos Health, LLC Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution, 0.2%/0.5% 8/25/2023NoN/AN/A 237Vyvanse NDA 021977214547Norwich Pharmaceuticals, Inc.Lisdexamfetamine Dimesylate Capsules, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg, 60 mg, and 70 mg8/25/2023NoN/AN/A 236Dexamethasone ANDA 088306217695Apotex Corp.Dexamethasone Tablets USP, 1 mg8/23/2023YesNo11/1/2023 235Zinc Sulfate NDA 209377217074Zydus 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 Vials8/22/2023NoN/AN/A 234Retin-A-Micro NDA 020475215609Encube Ethicals Private LimitedTretinoin Gel (Microsphere), 0.08%8/22/2023YesNo9/8/2023 233Calcium Gluconate in Sodium Chloride NDA 208418216541B. Braun Medical, Inc. Calcium Gluconate Injection 10,000 mg/100 mL (100 mg/mL), Pharmacy Bulk Package8/21/2023YesNo11/2/2023 232Balcoltra NDA 208612214640Xiromed Pharma Espana, S.L.Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets, 0.1 mg/0.02 mg and 75 mg8/16/2023NoN/AN/A 231Zonalon NDA 020126212357Amneal Pharmaceuticals LLCDoxepin Hydrochloride Cream, 5%8/16/2023NoN/AN/A 230Thiola ECNDA 211843216278Amneal Pharmaceuticals of New York, LLCTiopronin Delayed-Release Tablets, 300 mg8/15/2023NoN/AN/A 229Lithium Citrate NDA 018421218036Rubicon Research Private LimitedLithium Oral Solution USP, 8 mEq/5 mL8/14/2023YesNo9/20/2023 228Potassium Chloride ANDA 080205217704Nexus 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 Vials8/14/2023YesNo9/12/2023 227Lexette NDA 210566215266Padagis US LLCHalobetasol Propionate Topical Foam, 0.05%8/11/2023NoN/AN/A 226Lotemax NDA 202872215384Sun Pharmaceutical Industries, Inc.Loteprednol Etabonate Ophthalmic Gel, 0.5%8/9/2023NoN/AN/A 225Denavir NDA 020629216981Torrent Pharma Inc.Penciclovir Cream, 1%8/7/2023YesNo9/1/2023 224Vancomycin NDA 209481217401Eugia US LLCVancomycin Hydrochloride for Injection USP, 1.25 g/vial and 1.5 g/vial, Single-Dose vials8/4/2023NoN/AN/A 223Indocin NDA 017814216184Zydus Worldwide DMCCIndomethacin Suppositories USP, 50 mg8/2/2023YesNo8/3/2023 222Azopt NDA 020816211914Padagis US LLCBrinzolamide Ophthalmic Suspension USP, 1%7/28/2023YesNo10/10/2023 221Cardene NDA 019488215377Senores Pharmaceuticals, Inc.Nicardipine Hydrochloride Capsules, 20 mg and 30 mg7/17/2023YesNo9/22/2023 220Sodium Phenylacetate and Sodium Benzoate NDA 215025217526Navinta LLCSodium Phenylacetate and Sodium Benzoate Injection, 10% / 10% (2g - 2 g/20 mL [0.1 g - 0.1 g/mL]), Single-Dose Vial7/14/2023YesNo9/19/2023 219Sodium Chloride 23.4% NDA 019329217796Fresenius Kabi USA, LLC23.4% Sodium Chloride Injection USP, 800 mEq/200 mL (4 mEq/mL), Pharmacy Bulk Package7/11/2023YesNo7/27/2023 218Sterile Water NDA 018801217536Nexus Pharmaceuticals Inc.Sterile Water for Injection USP, 20 mL, Single-Dose Vial7/11/2023YesYesN/A 217Bismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride NDA 050786217511RinconPharma LLCBismuth Subcitrate Potassium, Metronidazole and Tetracycline Hydrochloride Capsules, 140 mg/125mg/125 mg 7/3/2023YesNo7/3/2023 216Vancomycin Hydrochloride NDA 209481217489Hikma Pharmaceuticals USA Inc.Vancomycin Hydrochloride for Injection USP, 1.25 g/vial and 1.5 g/vial, Single-Dose Vials6/29/2023YesNo8/16/2023 215Vancocin Hydrochloride ANDA 061667215338Amneal Pharmaceuticals LLCVancomycin Hydrochloride for Oral Solution USP, 250 mg/5 mL (50 mg/mL)6/23/2023YesNo6/23/2023 214Nasonex NDA 215712217460Amneal Pharmaceuticals LLCMometasone Furoate Nasal Spray, 50 mcg/spray (OTC)6/14/2023YesYesN/A 213Katerzia NDA 211340215035Amneal Pharmaceuticals LLCAmlodipine Benzoate Oral Suspension, 1 mg/mL (150 mL)6/13/2023NoN/AN/A 212Fleqsuvy NDA 215602217252Slayback Pharma LLCBaclofen Oral Suspension, 25 mg/5 mL (5 mg/mL)6/8/2023NoN/AN/A 211Foscavir NDA 020068213807Emcure Pharmaceuticals Ltd.Foscarnet Sodium Injection, 6,000 mg/250 mL (24 mg/mL) Single-Dose Bottle for Infusion6/5/2023NoN/AN/A 210Arranon NDA 021877215057Nexus Pharmaceuticals Inc.Nelarabine Injection, 250 mg/50 mL (5 mg/mL), Single-Dose Vial6/2/2023NoN/AN/A 209Fosamax NDA 021575214512Novitium Pharma LLCAlendronate Sodium Oral Solution, 70 mg (base)/75 mL5/11/2023YesNo5/24/2023 208Dexamethasone ANDA 081916217696Novitium Pharma LLCDexamethasone Tablets USP, 2 mg5/9/2023NoN/AN/A 207Calcium Disodium Versenate NDA 008922216435Casper Pharma LLCEdetate Calcium Disodium Injection, USP, 1,000 mg/5 mL (200 mg/mL), Single-Dose Vial5/3/2023YesNo7/12/2023 206Celontin NDA 010596217213Novitium Pharma LLCMethsuximide Capsules USP, 300 mg5/1/2023YesNo5/1/2023 205Dexamethasone ANDA 087916217538Bionpharma Inc.Dexamethasone Tablets USP, 2 mg4/26/2023NoN/AN/A 204Tazorac NDA 020600213079Padagis Israel Pharmaceuticals Ltd.Tazarotene Gel, 0.05% and 0.1% 4/25/2023NoN/AN/A 203Alrex NDA 020803215933Akorn Operating Company LLCLoteprednol Etabonate Ophthalmic Suspension, 0.2%4/12/2023YesYesN/A 202Uceris NDA 205613215328Padagis Israel Pharmaceuticals Ltd.Budesonide Rectal Foam, 2 mg/dose4/12/2023YesNo4/27/2023 201Paraflex NDA 011300214702Corepharma, LLCChlorzoxazone Tablets USP, 250 mg4/10/2023NoN/AN/A 200Arranon NDA 021877216346Amneal Pharmaceuticals LLCNelarabine Injection, 250 mg/50 mL (5 mg/mL), Single-Dose Vial4/4/2023NoN/AN/A 199Alphagan P NDA 021262215225Syneos Health, LLCBrimonidine Tartrate Ophthalmic Solution, 0.15%3/29/2023NoN/AN/A 198Amitiza NDA 021908214131Zydus Pharmaceuticals (USA) Inc.Lubiprostone Capsules, 8 mcg and 24 mcg3/23/2023NoN/AN/A 197Enstilar NDA 207589214688Glenmark Pharmaceuticals Inc., USA Calcipotriene and Betamethasone Dipropionate Foam, 0.005%/0.064%3/21/2023NoN/AN/A 196Tazorac NDA 020600213644Solaris Pharma CorporationTazarotene Gel, 0.05% and 0.1%3/20/2023NoN/AN/A 195Prednisolone ANDA 080354215673Aurobindo Pharma LimitedPrednisolone Tablets USP, 5 mg3/17/2023YesNo5/22/2023 194Arranon NDA 021877214809Shorla Pharma LimitedNelarabine Injection, 250 mg/50 mL (5 mg/mL), Single-Dose Vial3/3/2023NoN/AN/A 193Advil Dual Action with Acetaminophen NDA 211733214836L. Perrigo CompanyAcetaminophen and Ibuprofen Tablets, 250 mg/125 mg (OTC)2/28/2023NoN/AN/A 192Thiola EC NDA 211843217219Par Pharmaceutical, Inc.Tiopronin Delayed-Release Tablets, 100 mg and 300 mg2/24/2023NoN/AN/A 191Zonalon NDA 020126215408Teva Pharmaceuticals Development, Inc.Doxepin Hydrochloride Cream, 5%2/17/2023YesNo2/17/2023 190Trokendi XR NDA 201635216167Zydus Pharmaceuticals (USA) Inc.Topiramate Extended-Release Capsules, 200 mg2/9/2023NoN/AN/A 189Parafon Forte DSC NDA 011529212047Appco Pharma LLCChlorzoxazone Tablets USP, 375 mg and 750 mg1/27/2023NoN/AN/A 188Phenylephrine Hydrochloride NDA 207926216496Mankind Pharma LimitedPhenylephrine Hydrochloride Ophthalmic Solution USP, 10 %1/11/2023YesNo1/18/2023 187Arranon NDA 021877216038Meitheal Pharmaceuticals, IncNelarabine Injection, 250 mg/50 mL (5 mg/mL), Single-Dose Vial1/10/2023NoN/AN/A 186Orfadin NDA 021232215908Torrent Pharma Inc.Nitisinone Capsules, 20 mg1/9/2023YesYesN/A 185Zinc Sulfate NDA 209377216145Fresenius Kabi USA, LLCZinc 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 Package12/27/2022Yes (10 mg/10 mL); No (30 mg/10 mL); No (25 mg/5 mL)No2/15/2023 184Cupric Sulfate NDA 019350216324American Regent, Inc.Cupric Sulfate Injection USP, 4 mg/10 mL (0.4 mg/mL), Pharmacy Bulk Package12/26/2022YesYesN/A 183Uptravi NDA 207947214302Zydus Worldwide DMCCSelexipag Tablets, 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1,000 mcg, 1,200 mcg, 1,400 mcg, and 1,600 mcg12/21/2022NoN/AN/A 182Perforomist NDA 22007215621Slayback Pharma LLCFormoterol Fumarate Solution, 20 mcg/2 mL per Unit Dose Vial12/13/2022NoN/AN/A 181Potassium Chloride NDA 206814211665Strides Pharma Global Pte LimitedPotassium Chloride Oral Solution USP, 40 mEq/15 mL (20%)11/17/2022NoN/AN/A 180AmBisome NDA 050740214010Eugia US LLCAmphotericin B Injection, 50 mg/vial, Single-Dose Vial11/17/2022NoN/AN/A 179Durezol NDA 022212214894Dr. Reddy’s Laboratories LimitedDifluprednate Ophthalmic Emulsion, 0.05%11/16/2022NoN/AN/A 178Calcium Gluconate NDA 208418213071Nivagen Pharmaceuticals, IncCalcium Gluconate Injection USP, 1,000 mg per 10 mL (100 mg per mL), Single-Dose Vial10/14/2022YesNo11/6/2022 177Briviact NDA 205836214501Zydus Pharmaceuticals (USA) Inc.Brivaracetam Tablets, 10 mg, 25 mg, 50 mg,75 mg and 100 mg10/3/2022NoN/AN/A 176Phenylephrine NDA 207926216859Mankind Pharma Limited Phenylephrine Hydrochloride Ophthalmic Solution USP, 2.5% w/v (2 mL fill)9/29/2022YesNo10/7/2022 175Pathocil NDA 050011216845Aurobindo Pharma USA, IncDicloxacillin Sodium Capsules USP, 250 mg and 500 mg9/23/2022YesNo9/30/2022 174Timoptic in Ocudose NDA 019463216533Ingenus Pharmaceuticals, LLCTimolol Maleate Ophthalmic Solution USP, 0.25% (base) and 0.5% (base), Single-Dose Vials9/13/2022NoNoN/A 173Tazorac NDA 020600215433Cosette Pharmaceuticals, Inc.Tazarotene Gel, 0.05%9/13/2022YesNo9/14/2022 172Tazorac NDA 020600214136Cosette Pharmaceuticals, Inc.Tazarotene Gel, 0.01%9/13/2022YesNo9/14/2022 171Carafate NDA 19183212913Mylan Pharmaceuticals, Inc.Sucralfate Oral Suspension, 1 g/10 mL9/12/2022NoN/AN/A 170Dexamethasone ANDA 087916216295Amneal Pharmaceuticals LLCDexamethasone Tablets USP, 2 mg9/8/2022YesNo9/9/2022 169Lyrica CR NDA 209501215577Zydus Pharmaceuticals (USA) Inc.Pregabalin Extended-Release Tablets, 82.5 mg, 165 mg, and 330 mg8/26/2022NoN/AN/A 168Cetrotide NDA 021197215737Akorn Operating Company LLCCetrorelix Acetate for Injection, 0.25 mg/vial, Single-Dose Vial 8/12/2022YesNo10/24/2022 167Divigel NDA 022038211783Chemo Research S.L. Estradiol Gel, 0.1%8/10/2022YesNo10/10/2022 166Clindagel NDA 050782214668Amneal Pharmaceuticals LLCClindamycin Phosphate Gel USP, 1%8/5/2022YesNo8/5/2022 166Bactroban NDA 050746212465Padagis Israel Pharmaceuticals Ltd.Mupirocin Cream USP, 2%8/3/2022NoN/AN/A 164Taytulla NDA 204426213418Glenmark Pharmaceuticals LimitedNorethindrone Acetate and Ethinyl Estradiol Capsules and Ferrous Fumarate Capsules, 1 mg/20 mcg7/27/2022NoN/AN/A 163Vasostrict NDA 204485211857Amphastar Pharmaceuticals, Inc.Vasopressin Injection USP, 20 Units/mL, Single-Dose Vial7/18/2022NoN/AN/A 162Nalfon NDA 017604214475Rising Pharma Holdings, IncFenoprofen Calcium Capsules USP, 400 mg7/18/2022YesNo8/15/2022 161Atropine Sulfate NDA 206289214752Amneal Pharmaceuticals LLCAtropine Sulfate Ophthalmic Solution USP, 1%7/14/2022NoN/AN/A 160Isordil NDA 012093215723Rubicon Research Private LimitedIsosorbide Dinitrate Tablets USP, 40 mg7/8/2022NoN/AN/A 159Neostigmine Methylsulfate NDA 203629216291Dr. Reddy’s Laboratories LimitedNeostigmine Methylsulfate Injection USP, 3 mg/3 mL (1 mg/mL), Single-Dose Prefilled Syringe7/6/2022YesNo7/25/2022 158Plasma-Lyte 148 in Water NDA 017378215370Fresenius Kabi USA, LLCMultiple Electrolytes Injection Type 1 USP, pH 5.5, Single-Dose Containers6/29/2022YesYesN/A 157Carbaglu NDA 022562213395Navinta LLCCarglumic Acid Tablets for Oral Suspension, 200 mg6/22/2022NoN/AN/A 156Narcan NDA 208411211951Padagis Israel Pharmaceuticals Ltd.Naloxone Hydrochloride Nasal Spray, 4 mg/spray6/21/2022NoN/AN/A 155Infant’s Advil NDA 020812214071Strides Pharma IncIbuprofen Oral Suspension USP, 50 mg/1.25 mL (40 mg/mL) (OTC)6/9/2022YesYesN/A 154Plasma-Lyte A NDA 017378215371Fresenius Kabi USA, LLCMultiple Electrolytes Injection Type 1 USP, pH 7.4, Single-Dose Containers6/8/2022YesYesN/A 153Epiduo Forte NDA 207917214553Zydus Pharmaceuticals (USA) Inc.Adapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5%6/3/2022NoN/AN/A 152Epiduo Forte NDA 207917212464Padagis US LLCAdapalene and Benzoyl Peroxide Topical Gel, 0.3%/2.5%5/31/2022NoN/AN/A 151 Atropine Sulfate NDA 214652216120American Regent, IncAtropine Sulfate Injection USP, 0.4 mg/mL and 1 mg/mL, Single-Dose Vials5/26/2022YesNo8/2/2022 150Brovana NDA 021912215385Sun Pharmaceutical Industries LtdArformoterol Tartrate Inhalation Solution, 15 mcg/2 mL, Unit-Dose Vial5/26/2022NoN/AN/A 149Alimta NDA 021462214073Zydus Pharmaceuticals (USA) Inc.Pemetrexed for Injection USP, 1000 mg/vial5/25/2022NoN/AN/A 148Lexiscan NDA 022161214252International Medication Systems LimitedRegadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), Single-Dose Pre-Filled Syringe5/23/2022NoN/AN/A 147Visipaque NDA 20351214271Jiangsu Hengrui Pharmaceuticals Co., Ltd.Iodixanol Injection USP, 270 mg Iodine/mL and 320 mg Iodine/mL, Single Dose Bottles5/19/2022YesNo7/13/2022 146Pentasa NDA 020049214585Sun Pharma Industries LtdMesalamine Extended Release Capsules USP, 500 mg5/11/2022YesNo5/18/2022 145Brovana NDA 021912214779Alembic Pharmaceuticals LimitedArformoterol Tartrate Inhalation Solution, 15 mcg (base)/2 mL, Unit-dose Vial5/10/2022NoN/AN/A 144Zinc Sulfate NDA 209377216249Gland Pharma LimitedZinc Sulfate Injection USP, 30 mg/10 mL (3 mg/mL) and 25 mg/5 mL (5 mg/mL)5/3/2022Yes YesNo Yes6/27/2022 (30 mg/10 mL(3 mg/mL))

25 mg/5 mL (5 mg/mL)

143Targretin NDA 021056215398Amneal Pharmaceuticals LLCBexarotene Gel, 1%4/27/2022YesNo5/17/2022 142AquaMEPHYTON NDA 012223214596Cipla LimitedPhytonadione Injectable Emulsion USP, 1 mg/0.5 mL and 10 mg/mL, Single-Dose Vials4/22/2022YesNo5/3/2022 141AquaMEPHYTON NDA 012223212424Cipla LimitedPhytonadione Injectable Emulsion USP, 1 mg/0.5 mL and 10 mg/mL, Single-Dose Ampules4/22/2022Yes 5/3/2022 (by ANDA 214596) 140Sinequan NDA 016798213796Edenbridge Pharmaceuticals, LLCDoxepin Hydrochloride Capsules USP, 150 mg4/19/2022YesNo5/2/2022 139Mestinon NDA 015193212405Milla Pharmaceuticals, IncPyridostigmine Bromide Solution USP, 60 mg/5 mL4/19/2022NoN/AN/A 138Lexiscan 022161213210Dr. Reddy’s Laboratories Inc.Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), Single-Dose Pre-filled Syringe4/11/2022NoN/AN/A 137Ganirelix Acetate NDA 021057212613Amphastar Pharmaceuticals, Inc.Ganirelix Acetate Injection, 250 mcg/0.5 mL, Prefilled Syringe4/7/2022NoN/AN/A 136Noxafil NDA 205053212500Dr. Reddy’s Laboratories Inc.Posaconazole Delayed-Release Tablets, 100 mg4/7/2022NoN/AN/A 135Butalbital and Acetaminophen ANDA 089988214088Havix Group Inc.Butalbital and Acetaminophen Tablets, 25 mg/325 mg4/7/2022YesYesN/A 134BiDil NDA 020727215586Ricon Pharma LLCIsosorbide Dinitrate and Hydralazine Hydrochloride Tablets, 20 mg/37.5 mg4/6/2022YesNo4/12/2022 133Revatio NDA 203109211638Lupin Pharmaceuticals, IncSildenafil for Oral Suspension, 10 mg/mL3/23/2022NoN/AN/A 132Carafate NDA 019183211884VistaPharm, Inc.Sucralfate Oral Suspension, 1 g/10 mL3/15/2022YesNo3/15/2022 131Brovana NDA 021912214736VistaPharm, Inc.Arformoterol Tartrate Inhalation Solution, 15 mcg (base)/2 mL, Unit-Dose Vial3/2/2022NoN/AN/A 130Apokyn NDA 021264212025Sage Chemical, Inc.Apomorphine Hydrochloride Injection, 30 mg/3 mL(10 mg/mL), Single-Patient-Use glass cartridge 2/23/2022YesNo2/25/2022 129Veltin NDA 050803212845Solaris Pharma CorporationClindamycin Phosphate and Tretinoin Gel, 1.2%/0.025%2/10/2022YesNo4/12/2022 128Lanoxin NDA 020405214982Aurobindo Pharma LimitedDigoxin Tablets USP, 0.0625 mg2/8/2022Yes No2/17/2022 127Revex NDA 020459212955Purdue Pharma L.P.Nalmefene Hydrochloride Injection, 2 mg/2 mL (1 mg/mL), Single-Dose Vial2/8/2022YesRelinquishedN/A 126Cystadane NDA 020576210508Lukare Medical, LLCBetaine Anhydrous for Oral Solution, 180 grams/bottle1/28/2022NoN/AN/A 125Atropine Sulfate NDA 021146215342Amneal EU, LimitedAtropine Sulfate Injection USP, 0.5 mg/5 mL (0.1 mg/mL), Single-Dose Syringe1/26/2022NoN/AN/A 124Monurol NDA 050717211881Cipla USA, Inc. Fosfomycin Tromethamine Suspension, 3 g (base), Single-Dose Sachet1/26/2022NoN/AN/A 123Migranal NDA 020148214105Amneal Pharmaceuticals LLCDihydroergotamine Mesylate Nasal Spray, 4 mg/mL (1 mL Vial)1/4/2022NoN/AN/A 122AmBisome Liposome NDA 050740212514Sun Pharmaceutical Industries Inc.Amphotericin B Liposome for Injection, 50 mg/vial, Single-Dose Vial12/14/2021YesNo2/15/2022 121Timoptic NDA 019463212592Pharmaceutical Project Solutions, Inc.Timolol Maleate Ophthalmic Solution USP, 0.25% (base) and 0.5% (base), Single-Dose Vials12/13/2021YesNo2/26/2022 120Atropine Sulfate NDA 209260213561Hikma Pharmaceuticals USA Inc.Atropine Sulfate Injection USP, 8 mg/20 mL (0.4 mg/mL), Multi-Dose Vial12/1/2021NoN/AN/A 119Atropine Sulfate NDA 206289215624ApotexAtropine Sulfate Ophthalmic Solution, USP 1%11/26/2021YesNo11/26/2021 118Cystadane NDA 20576214864Novitium PharmaBetaine Anhydrous for Oral Solution, 180 grams/bottle11/23/2021YesNo2/3/2022 117Isordil NDA 012093211290Par Pharmaceutical, Inc.Isosorbide Dinitrate Tablets USP, 40 mg11/23/2021YesNo12/21/2021 116Perforomist NDA 022007215078Alembic Pharmaceuticals LimitedFormoterol Fumarate Inhalation Solution, 20 mcg/2 mL, Unit-Dose Vial11/22/2021NoN/AN/A 115Revatio NDA 203109212312Tris Pharma, Inc.Sildenafil for Oral Suspension, 10 mg/mL11/17/2021NoN/AN/A 114Arranon NDA 021877215037Zydus Pharmaceuticals (USA) Inc.Nelarabine Injection, 250 mg/50 mL (5 mg/mL), Single-Dose Vial11/17/2021YesNo11/23/2021 113Bactroban NDA 050746213053Aleor Dermaceuticals LimitedMupirocin Cream USP, 2%11/16/2021YesNo12/29/2021 112Librax NDA 012750211476Teva Pharmaceuticals USA, Inc.Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules USP, 5 mg/2.5 mg11/2/2021NoN/AN/A 111Prexxartan NDA 209139214102Novitium Pharma LLCValsartan Oral Solution, 20 mg/5 mL (4 mg/mL)11/2/2021YesYesN/A 110Monurol NDA 050171214554Alkem Laboratories LimitedFosfomycin Tromethamine Granules for Oral Solution, 3 g (base), Single-Dose Packet10/21/2021NoN/AN/A 109Decadron NDA 011664215106Amneal EU, LimitedDexamethasone Tablets USP, 4 mg and 6 mg10/14/2021YesNo4mg - 10/22/2021; 6 mg - 10/21/2021 108Carbaglu NDA 22562213729Novitium Pharma LLCCarglumic Acid Tablets for Oral Suspension, 200 mg10/13/2021YesNo12/20/2021 107Mexitil NDA 018873214089Aavis PharmaceuticalsMexiletine Hydrochloride Capsules USP, 150 mg, 200 mg, and 250 mg10/1/2021NoN/AN/A 106Zomig NDA 021450212469Padagis US LLCZolmitriptan Nasal Spray USP, 2.5 mg/spray and 5 mg/spray9/30/2021NoN/AN/A 105Absorica NDA 021951212333Upsher-Smith Laboratories, LLCIsotretinoin Capsules USP, 10 mg, 20 mg, and 30 mg9/21/2021NoN/AN/A 104Quinaglute NDA 016647212589Eywa Pharma Inc.Quinidine Gluconate Extended-Release Tablets USP, 324 mg9/17/2021YesYesN/A 103Paxil NDA 020710215003Novitium Pharma LLCParoxetine Oral Suspension, 10 mg (base)/5 mL9/3/2021YesNo9/13/2021 102Ortho Evra NDA 021180213977Teva Pharmaceuticals USA, Inc.Onsura (Norelgestromin and Ethinyl Estradiol Transdermal System), 150 mcg/35 mcg per day8/25/2021NoN/AN/A 101Aramine NDA 009509211304Slayback Pharma LLCMetaraminol Bitartrate Injection USP, 100 mg (base)/10 mL (10 mg (base)/mL), Multi-Dose Vial8/24/2021YesYesN/A 100Cuprimine NDA 019853213293InvaGen Pharmaceuticals, Inc.Penicillamine Capsules USP, 250 mg8/19/2021NoN/AN/A 99Clindagel NDA 050782212842Solaris Pharma CorporationClindamycin Phosphate Gel USP, 1%8/13/2021NoN/AN/A 98Loperamide Hydrochl