ANDA Approvals

New Drug Applications and 505(b)(2) Applications

Second Quarter

This chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA.

Approval Date	Reference Listed Drug	Generic Drug Name	NDA Holder	ANDA Applicant	ANDA #
04/01/2024	Corvert	Ibutilide Fumarate	Pfizer	Avet Lifesciences	204146
04/02/2024	Cleocin T	Clindamycin Phosphate	Pfizer	Alembic	212466
04/02/2024	Narcan	Naloxone HCl	Adapt Pharma	Fresenius Kabi	213573
04/02/2024	Brovana	Arformoterol Tartrate	Lupin	Pharmamax	214901
04/02/2024	Furosemide	Furosemide	American Regent	Saba Ilac Sanayive	215856
04/02/2024	Vimpat	Lacosamide	UCB	Medley Pharms	218014
04/03/2024	Hemabate	Carboprost Tromethamine	Pfizer	Micro Labs	218013
04/03/2024	Vfend	Voriconazole	PF Prism	Aspiro	218533
04/04/2024	Aubagio	Teriflunomide	Sanofi Aventis	Torrent	209697
04/05/2024	Mutamycin	Mitomycin	Bristol Labs	Fresenius Kabi	211269
04/05/2024	Prozac	Fluoxetine HCl	Eli Lilly	Strides Pharma	212684
04/05/2024	Ingrezza	Valbenazine Tosylate	Neurocrine	Lupin	216064
04/05/2024	Vimpat	Lacosamide	UCB	Hikma	216806
04/05/2024	Zioptan	Tafluprost	Thea Pharma	Ingenus Pharms	218002
04/05/2024	Halaven	Eribulin Mesylate	Esai	Gland Pharma	218047
04/08/2024	Children's Motrin	Ibuprofen	Johnson & Johnson	Aurobindo	213506
04/08/2024	Oracea	Doxycycline	Galderma	Lupin	216631
04/08/2024	Dextrose 5%	Dextrose	ICU Medical	American Regent	217263
04/08/2024	Neurontin	Gabapentin	Viatris	Laurus	217965
04/08/2024	Oracea	Doxycycline	Galderma	Dr. Reddy's Labs	218034
04/09/2024	Cefzil	Cefprozil	Corden Pharma	Alkem Labs Ltd.	90857
04/09/2024	Azilect	Rasagiline Mesylate	Teva	SKG Pharma	218163
04/10/2024	Cardene	Nicardipine HCl	Chiesi	SKG Pharma	218202
04/10/2024	Diprolene	Betamethasone Dipropionate	Organon	Aurobindo	218289
04/11/2024	Advil PM	Diphenhydramine Citrate / Ibuprofen	Haleon	PLD Acquisitions	211404
04/11/2024	Miacalcin	Calcitonin Salmon	Mylan	Dr. Reddy's Labs	215715
04/11/2024	Haldol	Haloperidol	Ortho McNeil	Mankind Pharma	216918
04/12/2024	Ocuflox	Ofloxacin	Allergan	Caplin	217904
04/15/2024	Vibra-Tabs	Doxycycline Hyclate	Pfizer	Nostrum Labs	209560
04/15/2024	Acticlate	Doxycycline Hyclate	Chartwell RX	Torrent	214356
04/16/2024	Tranexamic Acid	Tranexamic Acid	Exela Pharma	Nexus	216877
04/16/2024	Cetrotide	Cetrorelix Acetate	EMD Serono	Qilu	217776
04/16/2024	Tranexamic Acid	Tranexamic Acid	Exela Pharma	Gland Pharma	218599
04/17/2024	Cardene in 0.86% Sodium Chloride	Nicardipine HCl	Chiesi	InfoRLife	203978
04/17/2024	Zaroxolyn	Metolazone	i3Pharmaceuticals	Leading	218606
04/18/2024	Promacta Kit	Eltrombopag Olamine	Novartis	Annora Pharma	216620
04/19/2024	Haldol	Haloperidol	Ortho McNeil	Aurobindo	218789
04/22/2024	Estrogel	Estradiol	Ascend Theraps	Solaris Pharma	216160
04/22/2024	Rogaine	Minoxidil	Johnson & Johnson	Aurobindo	218616
04/23/2024	Isoptin	Verapamil HCl	MT Adams Technologies	Fresenius Kabi	216471
04/23/2024	Nasonex 24 Hour Allergy	Mometasone Furoate	Perrico Pharma	Apotex	217438
04/23/2024	Narcan	Naloxone HCl	Emergent	Amneal	217992
04/23/2024	Votrient	Pazopanib HCl	Novartis	Novugen	218231
04/24/2024	Cetrotide	Cetrorelix Acetate	EMD Serono	Livzon Grp.	214540
04/24/2024	Lotemax	Loteprednol Etabonate	Bausch	Lupin	215719
04/24/2024	Tricor	Fenofibrate	AbbVie	Yichang Humanwell	218548
04/25/2024	Renvela	Sevelamer Carbonate	Genzyme	Macleods	207291
04/25/2024	Xadago	Safinamide Mesylate	MDD US	Prinston	215739
04/25/2024	Emflaza	Deflazacort	PTC Therapeutics	Tris	217813
04/25/2024	Cetrotide	Cetrorelix Acetate	EMD Serono	Gland	218150
04/25/2024	Retin-A	Tretinoin	Valeant	Zydus	218561
04/26/2024	Advil Dual Action with Acetaminophen	Acetaminophen / Ibuprofen	Haleon	Glenmark	218311
04/29/2024	Mitigare	Colchicine	Hikma	Granules	210757
04/29/2024	Zetia	Ezetimibe	Organon	Macleods	211159
04/29/2024	Mitigare	Colchicine	Hikma	Aurobindo	215463
04/29/2024	Rydapt	Midostaurin	Novartis	Teva	216076
04/29/2024	Mitigare	Colchicine	Hikma	Annora Pharma	217620
04/29/2024	Isopto Atropine	Atropine Sulfate	Alcon Labs	Somerset Therapeutics	217791
04/29/2024	Retin-A	Tretinoin	Valeant	Alembic	217804
04/29/2024	Xylocaine 4%	Lidocaine HCl	Fresenius Kabi	The J Molner	218411
04/30/2024	Livalo	Pitavastatin Calcium	Kowa	Hetero Labs	205977
04/30/2024	Nexium 24 Hour	Esomeprazole Magnesium	AstraZeneca	Dr Reddy's Labs	207198
04/30/2024	Cupric Chloride	Cupric Chloride	Hospira	Somerset Therapeutics	216113
04/30/2024	Cupric Chloride	Cupric Chloride	Hospira	Stira	217626
05/01/2024	Lodine	Etodolac	Wyeth	Ipca Labs	204729
05/01/2024	Tamiflu	Oseltamivir Phosphate	Roche	Laurus	218565
05/02/2024	Sandostatin	Octreotide Acetate	Novartis	Shuangcheng	217860
05/02/2024	Prednisolone	Prednisolone	Watson	Zhejiang Xianju	218083
05/03/2024	Mozobil	Plerixafor	Genzyme	Gland Pharma	206644
05/03/2024	Travatan Z	Travoprost	Sandoz	Lupin	207040
05/03/2024	Velcade	Bortezomib	Takeda	Hetero Labs	212204
05/03/2024	Jadenu Sprinkle	Deferasirox	Novartis	Mylan	213146
05/03/2024	Accuneb	Albuterol Sulfate	Mylan	Lexenpharm	215571
05/06/2024	Xyzal	Levocetirizine Dihydrochloride	Sanofi	Ipca Labs	204626
05/06/2024	Trilafon	Perphenazine	Schering	Macleods	212545
05/06/2024	Transderm Scop	Scopolamine	Baxter Healthcare	Rhodes Pharms	215329
05/06/2024	Radicava	Edaravone	Mitsubishi Tanabe	Hikma	215508
05/06/2024	Radicava	Edaravone	Mitsubishi Tanabe	Dr. Reddy's Labs	215917
05/06/2024	Radicava	Edaravone	Mitsubishi Tanabe	Gland Pharma	216199
05/06/2024	Radicava	Edaravone	Mitsubishi Tanabe	Long Grove Pharms	218354
05/07/2024	Bentyl	Dicyclomine HCl	Allergan	Annora Pharma	217566
05/08/2024	Vasostrict	Vasopressin	Endo Operations	Dr. Reddy's Labs	213988
05/08/2024	Aczone	Dapsone	Almirall	Zydus	214019
05/08/2024	Astepro Allergy	Azelastine Hydrochloride	Bayer	Padagis	216801
05/09/2024	Renvela	Sevelamer Carbonate	Sanofi	Strides	211915
05/09/2024	Integrilin	Eptifibatide	Merck	Hong Kong	213599
05/09/2024	Dexamethasone	Dexamethasone	Hikma	Zydus	216284
05/09/2024	Zegerid OTC	Omeprazole / Sodium Bicarbonate	Riley Consumer	Dr. Reddy's Labs	217784
05/09/2024	Procomp	Prochlorperazine Maleate	Jubilant Cadista	Ajanta	218515
05/10/2024	Sustiva	Efavirenz	Merck	Macleods	91579
05/10/2024	Dacogen	Decitabine	Otsuka	Hetero Labs	215355
05/10/2024	Rydapt	Midostaurin	Novartis	Lupin	216015
05/10/2024	Calcium Gluconate	Calcium Gluconate	Fresenius Kabi	Amneal	216611
05/10/2024	Flonase Allergy Relief	Fluticasone Propionate	Haleon	Aurobindo	217088
05/10/2024	Vazculep	Phenylephrine HCl	Exela Pharma	Aspiro	218110
05/10/2024	Tamiflu	Oseltamivir Phosphate	Roche	Aurobindo	218131
05/10/2024	Cisplatin	Cisplatin	HQ Specialty	Qilu	218868
05/13/2024	Zanaflex	Tizanidine HCl	Legacy Pharma	Appco	213365
05/13/2024	Levophed	Norepinephrine Bitartrate	Hospira	Rising	218758
05/14/2024	Durezol	Difluprednate	Sandoz	Epic Pharma	207284
05/14/2024	Claritin-D 24 Hour	Loratadine / Pseudoephedrine Sulfate	Bayer Healthcare	Bionpharma	218017
05/14/2024	Diamox	Acetazolamide	Teva	Epic Pharma	218023
05/15/2024	Vimpat	Lacosamide	UCB	Chartwell RX	215154
05/16/2024	Vidaza	Azacitidine	Bristol-Myers Squibb	MSN Labs	212580
05/16/2024	Combigan	Brimonidine Tartrate / Timolol Maleate	AbbVie	Glenmark	214987
05/16/2024	Methotrexate Sodium	Methotrexate Sodium	Strides	Elite Labs	216453
05/17/2024	Exjade	Deferasirox	Novartis	Mylan	206585
05/17/2024	Lyrica	Pregabalin	Upjohn	Indoco	208113
05/17/2024	Descovy	Emtricitabine / Tenofovir Alafenamide Fumarate	Gilead Sciences	Apotex	214053
05/17/2024	Brovana	Arformoterol Tartrate	Lupin	CF Pharmtech	216303
05/20/2024	Seroquel	Quetiapine Fumarate	AstraZeneca	Ipca Labs	205983
05/20/2024	Trazodone HCl	Trazodone HCl	Pragma Pharms	Crossmedika	211116
05/21/2024	Restasis	Cyclosporine	AbbVie	Deva Holding	209811
05/21/2024	Proair HFA	Albuterol Sulfate	Teva	Armstrong Pharms	212447
05/21/2024	Carafate	Sucralfate	AbbVie	Strides	216474
05/21/2024	Somatuline Depot	Lanreotide Acetate	Ipsen Pharma	Invagen Pharms	217193
05/21/2024	Theo-Dur	Theophylline	Schering	Zydus	218063
05/22/2024	Irbesartan	Irbesartan	Sanofi Aventis	Ipca Labs	211056
05/22/2024	Pradaxa	Dabigatran Etexilate Mesylate	Boehringer Ingelheim	MSN Labs	213879
05/22/2024	Maxipime	Cefepime HCl	Hospira	Hikma	214402
05/23/2024	Alkeran	Melphalan HCl	Apotex	Hetero Labs	215024
05/23/2024	Phenylephrine HCl	Phenylephrine HCl	Paragon Bioteck	Caplin	215183
05/23/2024	Timoptic-XE	Timolol Maleate	Bausch	Amneal	216343
5/24/2024	Onyda XR	Clonidine HCl	Tris Pharma Inc.	Tris Pharma	N217645
05/24/2024	Vimpat	Lacosamide	UCB	Macleods	208466
05/24/2024	Tarceva	Erlotinib HCl	OSI Pharms	Hetero Labs	209267
05/28/2024	Entresto	Sacubitril / Valsartan	Novartis	Crystal	213605
05/28/2024	Entresto	Sacubitril / Valsartan	Novartis	Laurus	213676
05/28/2024	Entresto	Sacubitril / Valsartan	Novartis	Alembic	213682
05/28/2024	Pepcid AC	Famotidine	Johnson & Johnson	Contract Pharmacal	218003
05/29/2024	Neurontin	Gabapentin	Viatris	Ipca Labs	209855
05/29/2024	Children's Astepro Allergy	Azelastine HCl	Bayer	Apotex	216421
05/29/2024	Mycamine	Micafungin Sodium	Astellas	Biocon Pharma	216438
05/29/2024	Myfortic	Mycophenolic Sodium	Novartis	Novugen	216637
05/29/2024	Halog	Halcinonide	Sun	Encube	217671
06/03/2024	Lipitor	Atorvastatin Calcium	Upjohn	Macleods	208480
06/03/2024	Brovana	Arformoterol Tartrate	Lupin	Dr. Reddy's Labs	215032
06/03/2024	Methotrexate Sodium	Methotrexate Sodium	Strides Pharma	Alembic	217552
06/03/2024	Xeljanz XR	Tofacitinib Citrate	Pfizer	Aurobindo	218462
06/04/2024	Fosomax	Alendronate Sodium	Organon	Ipca Labs	206387
06/04/2024	Sinemet CR	Carbidopa / Levodopa	Organon	Rubicon	217482
06/04/2024	Cozaar	Losartan Potassium	Organon	Apotex	218551
06/05/2024	Ibrance	Palbociclib	Pfizer	Synthon Pharms	215570
06/05/2024	Astepro Allergy	Azelastine HCl	Bayer	Amneal	216576
06/06/2024	Effexor XR	Venlafaxine HCl	Upjohn	Alembic	217767
06/07/2024	Prolixin	Fluphenazine HCl	Apothecon	Rising	218283
06/07/2024	Acetadote	Acetylcysteine	Cumberland Pharms	Somerset Therapeutics	218397
06/10/2024	Zinc Sulfate	Zinc Sulfate	American Regent	Apotex	218059
06/11/2024	Pomalyst	Pomalidomide	Bristol-Myers Squibb	Apotex	210164
06/11/2024	Valcyte	Valganciclovir HCl	Cheplapharm	GPP	212876
06/11/2024	Nexium 24 Hour	Esomeprazole Magnesium	AstraZeneca	Glenmark	218092
06/11/2024	Lysteda	Tranexamic Acid	Amring Pharms	Rubicon	218320
06/12/2024	Zovirax	Acyclovir	Bausch	Taro	205470
06/12/2024	Veletri	Epoprostenol Sodium	Actelion	Mylan	213913
06/12/2024	Qoliana	Brimonidine Tartrate	Sandoz	Upsher Smith Labs	216772
06/12/2024	Intuniv	Guanfacine HCl	Takeda	Wanbang Biopharms	217638
06/12/2024	EC-Naprosyn	Naproxen	Atnahs Pharma	Novitium Pharma	218497
06/13/2024	Topamax	Topiramate	Janssen	Alkem	218482
06/14/2024	Stendra	Avanafil	Metuchen Pharms	Hetero Labs	209266
06/14/2024	Firazyr	Icatibant Acetate	Takeda	Alembic	213773
06/14/2024	Pradaxa	Dabigatran Etexilate Mesylate	Boehringer Ingelheim	Alembic	215233
06/14/2024	Alimta	Pemetrexed Disodium	Eli Lilly	Hetero Labs	215460
06/14/2024	Cambia	Diclofenac Potassium	Assertio	Taro	218011
06/17/2024	Dotarem	Gadoterate Meglumine	Guerbet	Hainan Poly	218073
06/18/2024	Sanctura	Trospium Chloride	Allergan	Macleods	206472
06/18/2024	Lidocaine	Lidocaine	Fougera	Aurobindo	217117
06/20/2024	Diprivan	Propofol	Fresenius Kabi	Aspiro	217013
06/21/2024	Vibramycin	Doxycycline Hyclate	Pfizer	Hainan Poly	217685
06/21/2024	Sodium Phosphates in Plastic Container	Sodium Phosphate, Dibasic, Heptahydrate / Sodium Phosphate, Monobasic, Anhydrous	Hospira	American Regent	218314
06/24/2024	Suprep Bowel Prep Kit	Magnesium Sulfate / Potassium Sulfate / Sodium Sulfate	Braintree Labs	Bionpharma	204135
06/24/2024	Sodium Chloride 0.9% in Plastic Container	Sodium Chloride	B Braun	Fresenius Kabi	213688
06/25/2024	Qsymia	Phentermine HCl / Topiramate	Vivus	Actavis	204982
06/25/2024	Busulfex	Busulfan	Otsuka	Eugia Pharma	215102
06/25/2024	Acyclovir Sodium	Acyclovir Sodium	Fresenius Kabi	DDReg Pharma	215404
06/25/2024	Dostinex	Cabergoline	Pfizer	SKG Pharma	218618
6/25/2024	Tepylute	Thiotepa	Shorla	Shorla	NDA216984
06/26/2024	Risperdal	Risperidone	Janssen	Ipca Labs	205104
06/26/2024	Tecfidera	Dimethyl Fumarate	Biogen	Macleods	210377
06/26/2024	Perforomist	Formoterol Fumarate	Mylan	Micro Labs	218304
06/26/2024	Invega	Paliperidone	Janssen	Ajanta Pharma	218514
06/27/2024	Oracea	Doxycycline	Galderma Labs	Alembic	217674
06/28/2024	Moviprep	Ascorbic Acid / Polyethylene Glycol 3350 / Potassium Chloride / Sodium Ascorbate / Sodium Chloride / Sodium Sulfate	Salix	Taro	207498
06/28/2024	Azilect	Rasagiline Mesylate	Teva	Macleods	208866
06/28/2024	Ultiva	Remifentanil HCl	Mylan	Nivagen Pharms	215635
06/28/2024	Rydapt	Midostaurin	Novartis	Dr. Reddy's Labs	215921
06/28/2024	Halaven	Eribulin Mesylate	Esai	Jiangxi Qingfeng	218281
6/28/2024	Alimtra	Pemetrexed	Eli Lilly	Apotex	N210661