ANDA Approvals

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

First 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	ANDA Holder	ANDA Applicant
1/3/2023	Depo-Medrol	Methylprednisolone Acetate	Pfizer	Slayback
1/4/2023	Toviaz	Fesoterodine Fumarate	Pfizer	Ani Pharms
1/4/2023	Toviaz	Fesoterodine Fumarate	Pfizer	Actavis
1/4/2023	Toviaz	Fesoterodine Fumarate	Pfizer	Alembic
1/4/2023	Toviaz	Fesoterodine Fumarate	Pfizer	Amneal
1/4/2023	Toviaz	Fesoterodine Fumarate	Pfizer	Accord Healthcare
1/5/2023	Toviaz	Fesoterodine Fumarate	Pfizer	Lupin
1/5/2023	Vimpat	Lacosamide	UCB	Actavis
1/5/2023	Vimpat	Lacosamide	UCB	Aurobindo
1/5/2023	Depo-Provera	Medroxyprogesterone Acetate	Pfizer	Hikma
1/5/2023	Retin-A	Tretinoin	Bausch	Taro Pharms
1/5/2023	Permitil	Fluphenazine HCl	Schering	Ajanta Pharma
1/5/2023	Jevtana Kit	Cabazitaxel	Sanofi	Sandoz
1/6/2023	Fetzima	Levomilnacipran HCl	AbbVie	Aurobindo
1/6/2023	Briviact	Brivaracetam	UCB	Aurobindo
1/6/2023	Nor-QD	Emzahh	Teva	Aurobindo
1/9/2023	Uloric	Febuxostat	Takeda	Zydus
1/9/2023	Effient	Prasugrel	Eli Lilly	Lupin
1/9/2023	Orfadin	Nitisinone	Swedish Orphan	Torrent
1/9/2023	Wellbutrin SR	Bupropion HCl	GlaxoSmithKline	Yichang Humanwell
1/10/2023	Glumetza	Metformin HCl	Bausch	Micro Labs
1/10/2023	Rexulti	Brexpiprazole	Otsuka	Zydus
1/10/2023	Naproxen	Naproxen Sodium	Bionpharma	Patheon Softgels
1/10/2023	Arranon	Nelarabine	Novartis	Kindos
1/11/2023	Phenylephrine HCl	Phenylephrine HCl	Akorn	Mankind
1/12/2023	Restasis	Cyclosporine	AbbVie	Apotex
1/12/2023	Infumorph	Morphine Sulfate	Hikma	Hikma
1/12/2023	Hetlioz	Tasimelteon	Vanda	MSN
1/13/2023	Ketalar	Ketamine HCl	Par	Fresenius Kabi
1/13/2023	Rykindo	Risperidone	Luye Pharma	Luye Pharma
1/17/2023	Celestone Soluspan	Betamethasone Acetate / Betamethasone Sodium Phosphate	Organon	Hikma
1/18/2023	Welchol	Colesevelam HCl	Cosette	Impax
1/18/2023	Unithroid	Levothyroxine Sodium	Amneal	Ascent Pharms
1/18/2023	Neurontin	Gabapentin	Pfizer	Rubicon
1/18/2023	Remeron	Mirtazapine	Organon	Prasco
1/18/2023	Benicar	Olmesartan Medoxomil	Cosette	MSN
1/19/2023	Imitrex	Sumatriptan Succinate	Glaxo	Baxter Healthcare
1/19/2023	Nasacort	Triamcinolone Acetonide	Sanofi	Apotex
1/19/2023	Rapamune	Sirolimus	Pfizer	MSN
1/20/2023	Nebupent	Pentamidine Isethionate	Fresenius Kabi	X-Gen Pharms Inc
1/23/2023	Primacor	Milrinone Lactate	Sanofi	Shandong
1/23/2023	Metrogel	Metronidazole	Galderma Labs	Cosette
1/23/2023	Adderall XR	Dextroamp Saccharate / Amp Aspartate / Dextroamp Sulfate / Amp Sulfate	Takeda	Granules
1/24/2023	Duragesic-100	Fentanyl-100	Janssen	Zydus Noveltech Inc
1/24/2023	Duragesic-12	Fentanyl-12	Janssen	Zydus Noveltech Inc
1/24/2023	Duragesic-25	Fentanyl-25	Janssen	Zydus Noveltech Inc
1/24/2023	Duragesic-37	Fentanyl-37	Janssen	Zydus Noveltech Inc
1/24/2023	Duragesic-50	Fentanyl-50	Janssen	Zydus Noveltech Inc
1/24/2023	Duragesic-75	Fentanyl-75	Janssen	Zydus Noveltech Inc
1/24/2023	Paraflex	Chlorzoxazone	Ortho McNeil	Belcher
1/24/2023	Ketalar	Ketamine HCl	Par	Gland Pharma Ltd
1/24/2023	Entereg	Alvimopan	Merck	Par Pharm
1/25/2023	Chantix	Varenicline Tartrate	PF Prism	Apotex
1/26/2023	Zytiga	Abiraterone Acetate	Janssen	Teva
1/26/2023	Cysteine HCl	Cysteine HCl	Hospira	Nivagen Pharms
1/26/2023	Imodium	Loperamide HCl	Johnson & Johnson	Rubicon
1/27/2023	Paraflex	Chlorzoxazone	Ortho McNeil	Appco
1/27/2023	Capoten	Captopril	Strides	Changzhou Pharm
1/27/2023	Triamcinolone Acetonide	Triamcinolone Acetonide	Padagis	Glasshouse Pharms
1/30/2023	Theophylline	Theophylline	Akorn	Leading
1/30/2023	Cubicin	Daptomycin	Merck	Xellia
1/31/2023	Levetiracetam In Sodium Chloride	Levetiracetam In Sodium Chloride	HQ Specialty Pharma	Fresenius Kabi USA
1/31/2023	Bacteriostatic Water for Injection	Sterile Water For Injection	Hospira	Hikma
1/31/2023	Rexulti	Brexpiprazole	Otsuka	Amneal
2/1/2023	Nebcin	Tobramycin Sulfate	Eli Lilly	Hainan Poly
2/2/2023	Vfend	Voriconazole	PF Prism	Eugia Pharma
2/2/2023	Quelicin	Succinylcholine Chloride	Hospira	Mankind
2/3/2023	Pennsaid 2%	Diclofenac Sodium	Horizon	Aurolife Pharma
2/3/2023	Rexulti	Brexpiprazole	Otsuka	Ajanta Pharma
2/6/2023	Vinpat	Lacosamide	UCB	Medley Pharms
2/7/2023	Linzess	Linaclotide	AbbVie	Aurobindo
2/7/2023	Robinul	Glycopyrrolate	Hikma	Lupin
2/7/2023	Aggrastat	Tirofiban HCl	Medicure	Nexus Pharms
2/8/2023	Revlimid	Lenalidomide	Celgene	Sun Pharm
2/8/2023	Fentanyl Citrate	Fentanyl Citrate	Exela	Exela
2/9/2023	Rozerem	Ramelteon	Takeda	Micro Labs
2/9/2023	Vimpat	Lacosamide	UCB	MSN
2/9/2023	Trokendi XR	Topiramate	Supernus	Zydus
2/9/2023	Protonix	Pantoprazole Sodium	Wyeth	Ajanta Pharma
2/10/2023	Jevtana Kit	Cabazitaxel	Sanofi	Dr Reddys
2/10/2023	Jevtana Kit	Cabazitaxel	Sanofi	Apotex
2/13/2023	Iressa	Gefitinib	AstraZeneca	Qilu Pharm Hainan
2/13/2023	Alesse	Levonorgestrel / Ethinyl Estradiol	Cadence	Hetero Labs
2/13/2023	Apresoline	Hydralazine HCl	Novartis	Eugia Pharma
2/13/2023	Hemabate	Carboprost Tromethamine	Pfizer	Caplin
2/14/2023	Treanada	Bendamustine HCl	Teva	Breckenridge
2/14/2023	Tamiflu	Oseltamivir Phosphate	Roche	Epic Pharma
2/15/2023	Rapamune	Sirolimus	Johnson & Johnson	Zydus
2/15/2023	Magnesium Sulfate In Plastic Container	Magnesium Sulfate In Plastic Container	Hospira	Amneal
2/17/2023	Revlimid	Lenalidomide	Celgene	Torrent
2/17/2023	Sinequan	Doxepin HCl	Pfizer	Teva
2/17/2023	Bloxiverz	Neostigmine Methylsulfate	Exela	Sagent Pharms
2/21/2023	Rythmol SR	Propafenone HCl	GlaxoSmithKline	Aurobindo
2/22/2023	Livalo	Pitavastatin Calcium	Kowa	Zydus
2/22/2023	Lioresal	Baclofen	Amneal	Rubicon
2/23/2023	Cozaar	Losartan Potassium	Organon	Granules
2/23/2023	Prevduo	Neostigmine Methylsulfate / Glycopyrrolate	Slayback	Slayback
2/24/2023	Benicar HCT	Olmesartan Medoxomil / Hydrochlorothiazide	Cosette	Zydus
2/24/2023	Zyprexa	Olanzapine	Eli Lilly	Cadila Pharms
2/24/2023	Thiola EC	Tiopronin	Mission	Par
2/27/2023	Eliquis	Apixaban	Bristol-Myers Squibb	Zydus
2/27/2023	Isovue-M 200	Iopamidol	Bracco	Hainan Poly
2/27/2023	Mexitil	Mexiletine HCl	Boehringer-Ingelheim	Leading
2/27/2023	Robinul	Glycopyrrolate	Hikma	Mankind
2/28/2023	Zovirax	Acyclovir	Bausch	Zydus
2/28/2023	Phenylephrine HCl	Phenylephrine HCl	Hikma	Avet Lifesciences
2/28/2023	Advil Dual Action	Acetaminophen / Ibuprofen	GlaxoSmithKline	Perrigo
2/28/2023	Ganirelix	Ganirelix Acetate	Merck	Gland Pharma
2/28/2023	Taxotere	Docetaxel	Sanofi	Alembic
3/1/2023	Trokendi XR	Topiramate	Supernus	Par
3/1/2023	Cardizem SR	Diltiazem HCl	Bausch	Twi
3/1/2023	Combogesic	Acetaminophen / Ibuprofen	AFT Pharma	AFT Pharma
3/2/2023	Avelox	Moxifloxacin HCl	Bayer	Hetero Labs
3/2/2023	Viread	Tenofovir Disoproxil Fumarate	Gilead	Reyoung Pharm
3/2/2023	Sabril	Vigabatrin	Lundbeck	Zydus
3/2/2023	Zemuron	Rocuronium Bromide	Organon	Caplin
3/2/2023	Tegretol XR	Carbamazepine	Novartis	Sciecure Pharma
3/2/2023	Renvela	Sevelamer Carbonate	Sanofi	Hangzhou Anprime
3/3/2023	Arranon	Nelarabine	Novartis	Shorla
3/3/2023	Bicnu	Carmustine	Avet Lifesciences	Myla
3/3/2023	Cialis	Tadalafil	Eli Lilly	Novitium Pharma
3/3/2023	Fluorouracil	Fluorouracil	Spectrum	Alembic
3/6/2023	Revlimid	Lenalidomide	Celgene	Arrow
3/6/2023	Pylera	Bismuth Subcitrate Potassium / Metronidazole / Tetracycline HCl	AbbVie	Par
3/6/2023	Revlimid	Lenalidomide	Celgene	Zydus
3/6/2023	Revlimid	Lenalidomide	Celgene	Cipla
3/6/2023	Revlimid	Lenalidomide	Celgene	Lotus Pharm
3/6/2023	Revlimid	Lenalidomide	Celgene	Sun Pharm
3/6/2023	Revlimid	Lenalidomide	Celgene	Eugia Pharma
3/6/2023	Revlimid	Lenalidomide	Celgene	Mylan
3/6/2023	Revlimid	Lenalidomide	Celgene	Cipla
3/6/2023	Thiamine	Thiamine HCl	Fresenius Kabi	Caplin
3/6/2023	Minipress	Prazosin HCl	Pfizer	Alembic
3/7/2023	Revlimid	Lenalidomide	Celgene	Apotex
3/7/2023	Eryc	Erythromycin	Mayne	Zydus
3/7/2023	Gemzar	Gemcitabine HCl	Hospira	Hikma
3/7/2023	Potassium Chloride	Potassium Chloride	Genus	Belcher
3/7/2023	Cardizem LA	Diltiazem HCl	Bausch	Amta
3/7/2023	Narcan	Naloxone	Amphastar	Emergent
3/8/2023	Vascepa	Icosapent Ethyl	Amarin	Dr Reddys
3/8/2023	Zyrtec-D 12 Hour	Cetirizine HCl / Pseudoephedrine HCl	Johnson & Johnson	Aurobindo
3/8/2023	Naropin	Ropivacaine HCl	Fresenius Kabi USA	Amneal
3/8/2023	Pepcid AC	Famotidine	Johnson & Johnson	Marksans Pharma
3/9/2023	Zyprexa	Olanzapine	Eli Lilly	Zydus
3/9/2023	VFend	Voriconazole	PF Prism	UBI
3/9/2023	Truvada	Emtricitabine / Tenofovir Disoproxil Fumarate	Gilead	Aurobindo
3/9/2023	Emerphed	Ephedrine Sulfate	Nexus	Sagent
3/9/2023	Zovirax	Acyclovir	Mylan	MSN
3/10/2023	Alimta	Pemetrexed Disodium	Eli Lilly	Mylan
3/10/2023	Trokendi XR	Topiramate	Supernus	Actavis
3/10/2023	Latuda	Lurasidone HCl	Sunovion	Aurobindo
3/10/2023	Advil Cold and Sinus	Ibuprofen / Pseudoephedrine HCl	GlaxoSmithKline	Aurobindo
3/10/2023	Colestid	Colestipol HCl	Pfizer	Praxgen
3/10/2023	Cleocin	Clindamycin HCl	Pfizer	Glenmark
3/13/2023	Aubagio	Teriflunomide	Sanofi	Hetero Labs
3/13/2023	Aubagio	Teriflunomide	Sanofi	Biocon Pharma
3/13/2023	Xeljanz	Tofacitinib Citrate	Pfizer	Micro Labs
3/13/2023	PhosLo GelCaps	Calcium Acetate	Fresenius	Square
3/14/2023	Xeljanz	Tofacitinib Citrate	Pfizer	Zydus
3/15/2023	Emtriva	Emtricitabine	Gilead	Aurobindo
3/15/2023	Lovenox	Enoxaparin Sodium	Sanofi	Shenzhen Techdow
3/15/2023	Cataflam	Diclofenac Potassium	Amici	Senores Pharms
3/15/2023	Nexium 24Hr	Esomeprazole Magnesium	AstraZeneca	Guardian Drug
3/15/2023	Duexis	Ibuprofen / Famotidine	Horizon	Ascent Pharms
3/15/2023	Gadavist	Gadobutrol	Bayer	Hainan Poly
3/16/2023	Ranexa	Ranolazine	Gilead	Unichem
3/17/2023	Prednisolone	Prednisolone	Watson	Aurobindo
3/17/2023	Compazine	Prochlorperazine Maleate	Glaxo	Glenmark
3/18/2023	Rexulti	Brexpiprazole	Otsuka	Lupin
3/20/2023	Fetzima	Levomilnacipran HCl	AbbVie	Prinston
3/20/2023	Tazorac	Tazarotene	AbbVie	Solaris Pharma
3/20/2023	Theo-Dur	Theophylline	Schering	Amneal
3/20/2023	Anafranil	Clomipramine HCl	SpecGX	Aurobindo
3/20/2023	DDAVP	Desmopressin Acetate	Ferring	Gland
3/21/2023	Sinequan	Doxepin HCl	Pfizer	Zydus
3/21/2023	Enstillar	Calcipotriene / Betamethasone Dipropionate	Leo	Glenmark
3/21/2023	Macrodantin	Nitrofurantoin	Almatica	Mankind
3/22/2023	Prandin	Repaglinide	Gemini Labs	Macleods
3/22/2023	Perforomist	Formoterol Fumarate	Mylan	Mankind
3/22/2023	Zyprexa	Olanzapine	Lilly	Aspiro
3/23/2023	Sinequan	Doxepin HCl	Pfizer	Zydus
3/23/2023	Timoptic-XE	Timolol Maleate	Bausch	Eugia
3/23/2023	Amitiza	Lubiprostone	Sucampo	Zydus
3/23/2023	Zytiga	Abiraterone Acetate	Johnson & Johnson	Florida
3/23/2023	Loperamide HCl	Loperamide HCl	Bionpharma	Zydus
3/24/2023	Claritin	Loratadine	Bayer	Aurobindo
3/24/2023	Amicar	Aminocaproic Acid	Akorn	Taro
3/24/2023	Tegretol XR	Carbamazepine	Novartis	Ajanta
3/24/2023	Bentyl	Dicyclomine HCl	Allergan	Corepharma
3/24/2023	Levothyroxine	Levothyroxine Sodium	Fresenius Kabi	Zydus
3/28/2023	Prevacid ODT	Lansoprazole	Takeda	Aurobindo
3/28/2023	Nexium	Esomeprazole Magnesium	AstraZeneca	Prinston
3/28/2023	Xylocaine Viscous	Lidocaine HCl	Fresenius Kabi	Rubicon
3/28/2023	Neurontin	Gabapentin	Viatris	Granules
3/29/2023	Climara	Estradiol	Bayer	Zydus
3/29/2023	Lyrica	Pregabalin	Upjohn	Aurobindo
3/29/2023	Alphagan P	Brimonidine Tartrate	AbbVie	Alembic
3/29/2023	Cardizem	Diltiazem HCl	Biovail Labs	Eugia Pharma
3/30/2023	Tradjenta	Linagliptin	Boehringer-Ingelheim	Zydus
3/30/2023	Jentadueto	Linagliptin / Metformin HCl	Boehringer-Ingelheim	Zydus
3/30/2023	Macrobid	Nitrofurantoin (Monohydrate / Macrocrystals)	Almatica	Aurobindo
3/30/2023	Vemlidy	Tenofovir Alafenamide	Gilead	Lupin
3/30/2023	Prolixin Decanoate	Fluphenazine Decanoate	Bristol-Myers Squibb	Gland Pharma
3/30/2023	Bystolic	Nebivolol HCl	AbbVie	Beximco Pharms
3/31/2023	Minipress	Prazosin HCl	Pfizer	Aurobindo
3/31/2023	Apriso	Mesalamine	Bausch	Aurobindo