ANDA Approvals

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

Third 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 #
07/01/2024	Octreoscan	Indium In-111 Pentetreotide Kitanda	Curium	Sun Pharm	212785
07/01/2024	Exparel	Bupivacaine Liposome	Pacira Pharms	Hengrui Pharma	214348
07/01/2024	Atropine Sulphate	Atropine Sulfate	Rising	Somerset	215618
07/01/2024	Bentyl	Dicyclomine HCl	Allergan	Annora Pharma	218018
07/01/2024	Silenor	Doxepin HCl	Currax	Ajanta	218564
07/02/2024	Tamiflu	Oseltamivir Phosphate	Roche	Oryza	217303
07/03/2024	Atropine Sulphate	Atropine Sulfate	Accord Healthcare	Somerset	215969
07/03/2024	Istalol	Timolol Maleate	Bausch and Lomb	Somerset	216653
07/03/2024	Timoptic	Timolol Maleate	Bausch and Lomb	Somerset	217764
07/05/2024	Restasis	Cyclosporine	AbbVie	Saptalis Pharms	211943
07/05/2024	Zinc Sulfate	Zinc Sulfate	American Regent	Nivagen Pharms	214597
07/05/2024	Glucophage XR	Metformin HCl	EMD Serono	Harman Finochem	218673
07/08/2024	Prolensa	Bromfenac Sodium	Bausch and Lomb	Apotex	207334
07/08/2024	Librax	Chlordiazepoxide HCL / Clidinium Bromide	Bausch Health	Winder Labs	212344
07/08/2024	Prolensa	Bromfenac Sodium	Bausch and Lomb	Alembic	214340
07/08/2024	Endari	L-Glutamine	Emmaus Medical	Novitium Pharma	215647
07/08/2024	Calcium Chloride	Calcium Chloride	Hospira	Amneal	217524
07/09/2024	Entresto	Sacubitril / Valsartan	Novartis	Zydus	213719
07/09/2024	Nymalize	Nimodipine	Azurity	Annora	216937
07/09/2024	Succinylcholine Chloride	Succinylcholine Chloride	Hikma	Steriscience	217873
07/10/2024	Cerdelga	Eliglustat Tartrate	Genzyme	Apotex	212425
07/10/2024	Robinul	Glycopyrrolatea	Casper Pharma	Quagen	212696
07/10/2024	Loteprednol Etabonate	Loteprednol Etabonate	Bausch and Lomb	Padagis	215203
07/10/2024	Vibisone	Cyanocobalamin	Fresenius Kabi	Mankind Pharma	217839
07/11/2024	Vasostrict	Vasopressin	Endo/Par	Long Grove	N217766
07/11/2024	Benicar HCT	Hydrochlorothiazide / Olmesartan Medoxomil	Cosette	Alkem Labs	207037
07/11/2024	Trokendi XR	Topiramate	Supernus	Lupin	215561
07/11/2024	Oracea	Doxycycline	Galderma Labs	Apotex	217170
07/11/2024	Potassium Phosphates	Potassium Phosphates	Fresenius Kabi	Somerset	217726
07/12/2024	Renvela	Sevelamer Carbonate	Sanofi Genzyme	InvaGen Pharms	206234
07/12/2024	Zemuron	Rocuronium Bromide	Organon	Shandong	215684
07/12/2024	Divigel	Estradiol	Vertical Pharms	Amneal	216055
07/12/2024	Divigel	Estradiol	Vertical Pharms	Solaris Pharma	217863
07/12/2024	Travatan Z	Travoprost	Sandoz	Gland Pharma	218159
07/15/2024	Suprep Bowel Prep Kit	Sodium Sulfate / Potassium Sulfate / Magnesium Sulfate	Braintree Labs	Lannett	209941
07/15/2024	Tazorac	Tazarotene	Allergan	Padagis	217075
07/16/2024	Doxil (Liposomal)	Doxorubicin HCl (Liposomal)	Baxter Healthcare	Fordoz	215178
07/16/2024	Synthroid	Levothyroxine Sodium	AbbVie	Aurobindo	216414
07/16/2024	Topamax	Topiramate	Janssen	Glenmark	217869
07/17/2024	Zinc Sulfate	Zinc Sulfate	American Regent	Somerset	216135
07/18/2024	Zituvimet XR	Metformin HCl / Sitagliptin	Merck	Zydus	N216778
07/18/2024	Jalyn	Dutasteride / Tamsulosin Hydrochloride	Waylis Therapeutics	Aurobindo	213300
07/18/2024	Halaven	Eribulin Mesylate	Eisai	Long Grove	214850
07/18/2024	Noxafil	Posaconazole	Merck	Aurobindo	217119
07/18/2024	Diazepam	Diazepam	Merck	Dr. Reddy's Labs	218422
07/18/2024	Akovaz	Ephedrine Sulfate	Exela Pharma	Caplin	219050
07/22/2024	Amrix	Cyclobenzaprine HCl	Teva	Macleods	207314
07/22/2024	Merrem	Meropenem	Pfizer	Qilu	216424
07/22/2024	Thiola EC	Tiopronin	Mission Pharmacal	Teva	216456
07/22/2024	Zemuron	Rocuronium Bromide	Organon	Steriscience	217092
07/22/2024	Olumiant	Baricitinib	Eli Lilly	Aurobindo	217542
07/22/2024	Pronestyl	Procainamide HCl	Apothecon	Gland	218135
07/22/2024	Diovan	Valsartan	Novartis	Zydus	218991
07/23/2024	Carafate	Sucralfate	AbbVie	Hikma	212769
07/23/2024	Chantix	Varenicline Tartrate	PF Prism	Slate Run	217115
07/23/2024	Vibramycin	Doxycycline Hyclate	Pfizer	Acic Pharms	217854
07/23/2024	Prolixin	Fluphenazine HCl	Apothecon	Alembic	218173
07/24/2024	Emtresto	Sacubitril / Valsartan	Novartis	MSN	213748
07/25/2024	Kaletra	Lopinavir and Ritonavir	AbbVie	Macleods	204739
07/26/2024	Toprol-XL	Metoprolol Succinate	Toprol	Zhejiang Jutai Pharm	214110
07/29/2024	Prolensa	Bromfenac Sodium	Bausch and Lomb	Amneal	210962
07/30/2024	Naropin	Ropivacaine HCl	Fresenius Kabi	Kindos	218713
08/01/2024	Lodine	Etodolac	Wyeth	Ipca Labs	205448
08/01/2024	Daptomycin	Daptomycin	Sagent Pharms	Fresenius Kabi	213396
08/01/2024	Ocuflox	Ofloxacin	Allergan	Somerset	213597
08/01/2024	Pantoprazole Sodium	Pantoprazole Sodium	Hikma	Fresenius Kabi	216021
08/01/2024	Arranon	Nelarabine	Sandoz	Alembic	218554
08/02/2024	Vagifem	Estradiol	Novo Nordisk	Aurobindo	216550
08/02/2024	Pred Forte	Prednisolone Acetate	AbbVie	Lupin	216935
08/05/2024	Polytrim	Trimethoprim Sulfate / Polymyxin B Sulfate	Allergan	Somerset	211572
08/05/2024	Lexiscan	Regadenoson	Astellas	GE Healthcare	215955
08/05/2024	Soriatane	Acitretin	Stiefel Labs	Alembic	217774
08/05/2024	Diovan	Valsartan	Novartis	Zenara	218169
08/06/2024	Isuprel	Isoproterenol HCl	Bausch Health	Somerset	211590
08/06/2024	Pepcid	Famotidine	Bausch	MSN	217400
08/07/2024	Crexont	Carbidopa / Levodopa	Impax	Impax	N217186
08/07/2024	Ingrezza	Valbenazine Tosylate	Neurocrine	Zydus	216137
08/07/2024	Timoptic	Timolol Maleate	Bausch and Lomb	Caplin	218460
08/07/2024	Zanaflex	Tizanidine HCl	Legacy Pharma	Graviti Pharms	218920
08/08/2024	Desyrel	Trazodone HCl	Pragma	Granules	218988
08/09/2024	Alcaine	Proparacaine HCl	Novartis	Somerset	215816
08/09/2024	Alphagan P	Brimonidine Tartrate	AbbVie	Somerset	216906
08/12/2024	Pradaxa	Dabigatran Etexilate Mesylate	Boehringer Ingelheim	MSN	213879
08/12/2024	Pradaxa	Dabigatran Etexilate Mesylate	Boehringer Ingelheim	Alembic	215233
08/12/2024	Sterile Water	Sterile Water	B Braun	Fresenius Kabi	216123
08/12/2024	Midazolam in 0.9% Sodium Chloride	Midazolam in 0.9% Sodium Chloride	InfoRLife	Gland Pharma	218993
08/13/2024	Pradaxa	Dabigatran Etexilate Mesylate	Boehringer Ingelheim	Hetero Labs	207961
08/13/2024	Cialis	Tadalafil	Eli Lilly	Fourrts Labs	217606
08/14/2024	Urso 250	Ursodiol	Allergan	Epic Pharma	214717
08/14/2024	Bepreve	Bepotastine Besilate	Bausch and Lomb	Somerset	217770
08/15/2024	Naropin	Ropivacaine HCl	Fresenius Kabi	Hikma	211907
08/15/2024	Propofol	Propofol	Fresenius Kabi	Amneal	217525
08/15/2024	Tranexamic Acid	Tranexamic Acid	Exela Pharma	Fresenius Kabi	218242
08/16/2024	Brilinta	Ticagrelor	AstraZeneca	Prinston	208599
08/16/2024	Colestid	Colestipol HCl	Pfizer	Edenbridge Pharms	217667
08/16/2024	Tykerb	Lapatinib Ditosylate	Novartis	Teva	217968
08/19/2024	Cuvposa	Glycopyrrolate	Merz	Granules	214735
08/19/2024	Arixtra	Fondaparinux Sodium	Mylan	Hangzhou Zhongmei	216493
08/19/2024	Cupric Sulfate	Cupric Sulfate	Abraxis	Apotex	218745
08/20/2024	Livalo	Pitavastatin Calcium	Kowa	Amneal	205961
08/20/2024	Onexton	Clindamycin Phosphate / Benzoyl Peroxide	Bausch	Padagis	209610
08/20/2024	Tepadina	Thiotepa	Adienne	Beloteca	217559
08/20/2024	Lucemyra	Lofexidine HCl	US World Meds	Indoco	218613
08/21/2024	Apresoline	Hydralazine HCl	Novartis	Macleods	211010
08/21/2024	Latuda	Lurasidone HCl	Sunovion Pharms	Annora Pharma	218174
08/22/2024	Asacol	Mesalamine	AbbVie	Teva	213191
08/22/2024	Entresto	Sacubitril / Valsartan	Novartis	Torrent	213604
08/22/2024	Luxiq	Betamethasone Valerate	Norvium Bioscience	Alembic	215832
08/22/2024	Tiglutik Kit	Riluzole	Italfarmaco	Alkem Labs	216035
08/22/2024	Lexiscan	Regadenoson	Astellas	Indies Pharma	218054
08/22/2024	Apriso	Mesalamine	Salix	Novast Labs	218410
08/23/2024	Temodar	Temozolomide	Merck	Hetero Labs	210030
08/23/2024	Acetaminophen / Ibuprofen	Acetaminophen / Ibuprofen	Haleon	Dr. Reddy's Labs	218247
08/26/2024	Velcade	Bortezomib	Takeda	Shilpa	N212782
08/26/2024	Relistor	Methylnaltrexone Bromide	Salix	Actavis	208112
08/26/2024	Alphagan P	Brimonidine Tartrate	AbbVie	Lupin	213215
08/26/2024	Aczone	Dapsone	Almirall	Acrux DDS	213636
08/26/2024	Gocovri	Amantadine HCl	Adamas	Zydus	214897
08/27/2024	Amrix	Cyclobenzaprine HCl	Teva	Novast Labs	214732
08/27/2024	Nimbex	Cisatracurium Besylate Preservative Free	AbbVie	Hainan Poly	216539
08/27/2024	Detrol LA	Tolterodine Tartrate	Upjohn	Unichem	216917
08/27/2024	Desyrel	Trazodone HCl	Pragma	Graviti Pharms	217740
08/28/2024	Cuvposa	Glycopyrrolate	Merz	Chartwell RX	216368
08/28/2024	Nuedexta	Dextromethorphan Hydrobromide / Quinidine Sulfate	Avanir Pharms	Hetero Labs	218426
08/29/2024	Cubicin	Daptomycin	Cubist	Biocon Pharma	217215
08/29/2024	Transderm Scop	Scopolamine	Baxter Healthcare	Zydus	217893
08/30/2024	Prevymis	Letermovir	Merck	Merck	219104
08/30/2024	Entresto	Sacubitril / Valsartan	Novartis	Biocon Pharma	213680
09/03/2024	Tradjenta	Linagliptin	Boehringer Ingelheim	Invagen	208423
09/04/2024	Vimpat	Lacosamide	UCB	Unichem	213109
09/04/2024	Albenza	Albendazole	Impax Labs	Alembic	215652
09/05/2024	Corlanor	Ivabradine HCl	Amgen	Bionpharma	213276
09/05/2024	Solu-Cortef	Hydrocortisone Sodium Succinate	Pharmacia and Upjohn	Cipla	214050
09/05/2024	Theo-Dur	Theophylline	Schering-Plough	Strides	215312
09/05/2024	Arranon	Nelarabine	Sandoz	XGen Pharms	216510
09/06/2024	Targretin	Bexarotene	Valeant	Ascent	208628
09/06/2024	Klor-Con	Potassium Chloride	Upsher Smith	Macleods	212987
09/06/2024	Adrenalin	Epinephrine	Endo	AM Regent	217192
09/06/2024	Nicardipine HCl	Nicardipine HCl	Hikma	Chengdu Shuode	217548
09/09/2024	Gralise	Gabapentin	Almatica	Abon Pharms	203643
09/09/2024	Dostinex	Cabergoline	Pfizer	Welding	218109
09/10/2024	Zyrtec-D 12 Hour	Cetirizine HCl / Pseudoephedrine HCl	Johnson & Johnson	Unichem	210507
09/10/2024	Combigan	Brimonidine Tartrate / Timolol Maleate	AbbVie	Somerset	216114
09/11/2024	Pradaxa	Dabigatran Etexilate Mesylate	Boehringer Ingelheim	Alkem	208040
09/11/2024	Busulfex	Busulfan	Otsuka	Prinston	215235
09/11/2024	Revlimid	Lenalidomide	Bristol-Myers Squibb	Novugen	217281
09/12/2024	Flexeril	Cyclobenzaprine HCl	Janssen	Graviti Pharms	218936
09/13/2024	Tarceva	Erlotinib HCl	OSI Pharmaceuticals	Hikma	203843
09/13/2024	Compazine	Prochlorperazine Edisylate	GlaxoSmithKline	Somerset	212257
09/13/2024	Fluoxetine HCl	Fluoxetine HCl	TWi	Strides	212683
09/13/2024	Arranon	Nelarabine	Sandoz	MSN	216948
09/16/2024	Timoptic-XE	Timolol Maleate	Bausch and Lomb	Somerset	210640
09/16/2024	Entresto	Sacubitril / Valsartan	Novartis	Alkem Labs	213764
09/16/2024	Rapamune	Sirolimus	PF Prism CV	Hetero Labs	215080
09/16/2024	Nizoral	Ketoconazole	Janssen	Novitium	218498
09/17/2024	Metyrosine	Metyrosine	Bausch Health	Leading	215541
09/17/2024	Minipress	Prazosin HCl	Pfizer	MSN	216727
09/17/2024	Steglatro	Ertugliflozin	Merck	Hetero Labs	217071
09/17/2024	Bumex	Bumetanide	Validus	Lupin	217153
09/17/2024	Dexamethasone	Dexamethasone	Hikma	Corepharma	218372
09/18/2024	Bumex	Bumetanide	Validus	Appco	212931
09/19/2024	Nubain	Nalbuphine HCl	Endo	Somerset	216049
09/19/2024	Nubain	Nalbuphine HCl	Endo	Somerset	216050
09/19/2024	Vasotec	Enalapril Maleate	Bausch Health	Unique Pharm	218531
09/19/2024	Bumex	Bumetanide	Validus	Qilu Pharm Hainan	219116
09/20/2024	Evoxac	Cevimeline HCl	Cosette	Macleods	206808
09/20/2024	D.H.E. 45	Dihydroergotamine Mesylate	Bausch Health	Cipla	212334
09/20/2024	Miacalcin	Calcitonin Salmon	Mylan	Cipla	213766
09/20/2024	Plavix	Clopidogrel Bisulfate	Sanofi Aventis	MSN	215388
09/23/2024	Travatan Z	Travoprost	Sandoz	Somerset	217228
09/24/2024	Nicardipine HCl	Nicardipine HCl	Hikma	Cipla	215592
09/24/2024	Fluorouracil	Fluorouracil	Spectrum Pharms	Kindos	216494
09/24/2024	Dexmedetomidine HCl	Dexmedetomidine HCl	HQ Specialty	Somerset	218112
09/24/2024	Chlorpromazine HCl	Chlorpromazine HCl	Hikma	Deva	218229
09/24/2024	Anectine	Succinylcholine Chloride	Sandoz	Baxter Healthcare	218878
09/25/2024	Copaxone	Glatiramer Acetate	Teva	Synthon Pharms	203857
09/25/2024	Copaxone	Glatiramer Acetate	Teva	Synthon Pharms	206873
09/26/2024	Lamictal	Lamotrigine	GlaxoSmithKline	Ipca Labs	204499
09/26/2024	Xtandi	Enzalutamide	Astellas	Zydus	209667
09/26/2024	Pomalyst	Pomalidomide	Bristol-Myers Squibb	Hetero Labs	210236
09/26/2024	Amicar	Aminocaproic Acid	Hikma	MSN	215100
09/26/2024	Cellcept	Mycophenolate Mofetil	Roche Palo	Aurobindo	218227
09/26/2024	Invega	Paliperidone	Janssen	Alembic	218330
09/26/2024	Symmetrel	Amantadine HCl	Endo Pharms	Zhejiang Jutai	218598
09/27/2024	Denavir	Penciclovir	Mylan	Padagis	212368
09/30/2024	Slynd	Drospirenone	Exeltis USA	Lupin	216936
09/30/2024	Compazine	Prochlorperazine Maleate	GlaxoSmithKline	Leading	218912