ANDA Approvals of Q2 - Spring 2023 | Hatch-Waxman

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

Second Quarter

This ANDA Approvals 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
04/03/2023	Silenor	Doxepin HCl	Currax	MSN
04/04/2023	Effexor XR	Venlafaxine HCl	Upjohn	Nostrum
04/04/2023	Diamox	Acetazolamide	Teva	Zydus
04/04/2023	Lexiscan	Regadenoson	Astellas	Mylan
04/04/2023	Sinemet	Carbidopa / Levodopa	Organon	Zydus
04/04/2023	Arranon	Nelarabine	Novartis	Amneal
04/04/2023	Compazine	Prochlorperazine Maleate	GlaxoSmithKline	Bionpharma
04/04/2023	Daliresp	Roflumilast	AstraZeneca	Camber / Hetero
04/05/2023	Bepreve	Bepotastine Besilate	Bausch and Lomb	Alembic
04/05/2023	Clindamycin Phosphate in Dextrose 5%	Clindamycin Phosphate in Dextrose 5%	Abraxix	Hikma
04/05/2023	Bepreve	Bepotastine Besilate	Bausch and Lomb	Alembic
04/06/2023	Cardizem LA	Diltiazem HCl	Bausch	Sciegen Pharms
04/06/2023	Evoxac	Cevimeline HCl	Cosette	Rubicon
04/07/2023	Otezla	Apremilast	Amgen	Shilpa
04/07/2023	Zithromax	Azithromycin	Pfizer	Zydus
04/10/2023	Kerydin	Tavaborole	Anacor	Zydus
04/10/2023	Celebrex	Celecoxib	Upjohn	Yabao Pharm
04/10/2023	Paraflex	Chlorzoxazone	Ortho McNeil	Corepharma
04/10/2023	Sular	Nisoldipine	Covis	Amta
04/11/2023	Valcyte	Valganciclovir HCl	Cheplapharm	APPCO
04/11/2023	Zithromax	Azithromycin	Pfizer	Zydus
04/11/2023	Valcyte	Valganciclovir HCl	Cheplapharm	Appco
04/12/2023	Venlafaxine HCl	Venlafaxine HCl	Osmotica	Ajanta Pharma
04/12/2023	Uceris	Budesonide	Bausch	Padagis
04/12/2023	Doryx	Doxycycline Hyclate	Fresenius Kabi	Gland Pharma
04/12/2023	Alrex	Loteprednol Etabonate	Bausch and Lomb	Akorn
04/12/2023	Nexavar	Sorafenib Tosylate	Bayer	Torrent
04/13/2023	Depo-Medrol	Methylprednisolone Acetate	Pfizer	Eugia Pharma
04/13/2023	Depo-Testosterone	Testosterone Cypionate	Pfizer	Xiromed
04/14/2023	Isuprel	Isoproterenol HCl	Bausch	Zydus
04/14/2023	Furadantin	Nitrofurantoin	Casper Pharma	Novitium Pharma
04/14/2023	Piperacillin / Tazobactam	Piperacillin / Tazobactam	Wockhardt Bio	Shandong
04/14/2023	RizaFilm	Rizatriptan Benzoate	IntelGenx	IntelGenx
04/17/2023	Menostar	Estradiol	Bayer Healthcare	Zydus
04/17/2023	Prograf	Tacrolimus	Astellas	Hangzhou Zhongmei
04/17/2023	Daliresp	Roflumilast	AstraZeneca	Aurobindo
04/17/2023	Midazolam	Midazolam	InfoRLife	Hikma
04/17/2023	Compazine	Prochlorperazine Maleate	GlaxoSmithKline	Amneal
04/18/2023	Acetaminophen	Acetaminophen	B Braun Medical	Wockhardt Bio
04/18/2023	Daliresp	Roflumilast	AstraZeneca	Zydus
04/18/2023	Luxiq	Betamethasone Valerate	Mylan	Xiromed
04/18/2023	Daliresp	Roflumilast	AstraZeneca	Alkem
04/18/2023	Evoxac	Cevimeline HCl	Cosette	Aurobindo
04/19/2023	Viagra	Sildenafil Citrate	Vaitris	Macleods
04/19/2023	Nimbex	Cisatracurium Besylate	AbbVie	Hikma
04/19/2023	Renvela	Sevelamer Carbonate	Sanofi	Macleods
04/19/2023	Lopressor	Metoprolol Tartrate	Validus	Zydus
04/19/2023	Dexamethasone	Dexamethasone	Hikma	Bionpharma
04/19/2023	Acetadote	Acetylcysteine	Cumberland Pharms	Steriscience
04/20/2023	Trisenox	Arsenic Trioxide	Cephalon	Orbicular
04/20/2023	Vascepa	Icosapent Ethyl	Amarin Pharms	Zydus
04/21/2023	Brilinta	Ticagrelor	AstraZeneca	Alkem
04/21/2023	Metrocream	Metronidazole	Galderma Labs	Zydus
04/24/2023	Pepcid AC	Famotidine	Johnson & Johnson / McNeil	Alkem Labs
04/25/2023	Tazorac	Tazarotene	Allergan	Padagis
04/26/2023	Iressa	Gefitinib	AstraZeneca	Actavis
04/26/2023	Isuprel	Isoproterenol HCl	Bausch	Hikma
04/26/2023	Lyrica	Pregabalin	Upjohn	ACI
04/26/2023	Dexamethasone	Dexamethasone	Hikma	Bionpharma
04/27/2023	Thalomid	Thalidomide	Celgene	Natco
04/27/2023	Parafon Forte	Chlorzoxazone	Janssen	Acme Labs
04/27/2023	Intuniv	Guanfacine HCl	Takeda	Ajanta
04/28/2023	Treanda	Bendamustine HCl	Cephalon	Mylan
04/28/2023	Sabril	Vigabatrin	Lundbeck	Propel Pharma
04/28/2023	Delestrogen	Estradiol Valerate	Par Sterile	Xiromed
05/01/2023	Amitriptyline HCl	Amitriptyline HCl	Sandoz	Rubicon
05/01/2023	Aggrastat	Tirofiban HCl	Medicure	Eugia Pharma
05/01/2023	Celontin	Methsuximide	Parke Davis	Novitium Pharma
05/01/2023	Cosopt PF	Dorzolamide HCl / Timolol Maleate	Thea Pharma	Ingenus Pharms
05/02/2023	Ivanz	Ertapenem Sodium	Merck	Sun Pharm
05/02/2023	Cerdelga	Eliglustat Tartrate	Genzyme	Zenara
05/03/2023	Ofirmev	Acetaminophen	Mallinckrodt	HQ Specialty Pharma
05/03/2023	Carafate	Sucralfate	AbbVie	Zydus
05/03/2023	Edetate	Calcium Disodium Versenate	Bausch Health	Casper Pharma
05/03/2023	Cardene	Nicardipine HCl	Chiesi USA	Square Pharms
05/04/2023	Motpoly XR	Lacosamide	Aucta	Aucta
05/04/2023	Trokendi XR	Topiramate	Supernus	Par
05/08/2023	Zemuron	Rocuronium Bromide	Organon USA	Hong Kong
05/08.2023	Dibenzyline	Phenoxybenzamine HCl	Concordia	Aurobindo
05/08/2023	Timoptic in Ocudose	Timolol Maleate	Bausch and Lomb	Sentiss Pharma
05/09/2023	Ambien	Zolpidem Tartrate	Sanofi	Almatica
05/09/2023	Diamox	Acetazolamide	Teva	Aarksih Pharms
05/09/2023	Dexamethasone	Dexamethasone	Hikma	Novitium Pharma
05/10/2023	Propylthiouracil	Propylthiouracil	Dava Pharms	Macleods
05/10/2023	Toradol	Ketorolac Tromethamine	Roche Palo Alto	Caplin
05/11/2023	Abraxane	Paclitaxel	Abraxis	Teva
05/11/2023	Docetaxel	Docetaxel	Accord Healthcare	Mylan
05/11/2023	Revlimid	Lenalidomide	Celgene	Hetero Labs
05/11/2023	Furadantin	Nitrofurantoin	Casper Pharma	Aurobindo
05/11/2023	Theophylline	Theophylline	Bausch	Rhodes
05/11/2023	Fosamax	Alendronate Sodium	Merck	Novitium Pharma
05/11/2023	Bicnu	Carmustine	Avet Lifesciences	MSN
05/11/2023	Voltaren	Diclofenac Sodium	Novartis	Rubicon
05/12/2023	Lialda	Mesalamine	Takeda	Sinotherapeutics
05/12/2023	Neurontin	Gabapentin	Viatris	Laurus
05/15/2023	Aubagio	Teriflunomide	Sanofi	Natco
05/15/2023	Pepcid	Famotidine	Johnson & Johnson	Alkem
05/15/2023	Precedex	Dexmedetomidine HCl	Hospira	Amneal
05/15/2023	Banzel	Rufinamide	Esai	Micro Labs
05/16/2023	Emend	Fosaprepitant Dimeglumine	Merck	Piramal Critical
05/16/2023	Nalfon	Fenoprofen Calcium	Xspire Pharma	Misemer
05/16/2023	Akovaz	Ephedrine Sulfate	Exela Pharma	Zydus
05/17/2023	Lymphazurin	Isosulfan Blue	Covidien	AM Regent
05/18/2023	Effexor XR	Venlafaxine HCl	Upjohn	Granules
05/19/2023	Hemabate	Carboprost Tromethamine	Pfizer	Welding
05/19/2023	Amitriptyline HCl	Amitriptyline HCl	Sandoz	Graviti Pharms
05/22/2023	Alimta	Pemetrexed	Eli Lilly	Shilpa
05/22/2023	Fusilev	Levoleucovorin Calcium	Spectrum	Hainan Poly Pharm
05/23/2023	Brixadi	Bupremorphine	Braeburn	Braeburn
05/23/2023	Allegra	Fexofenadine HCl	Chattem Sanofi	Aurobindo
05/23/2023	Concerta	Methylphenidate HCl	Janssen	Alkem
05/23/2023	Haldol	Haloperidol Decanoate	Janssen	Mankind Pharma
05/23/2023	Lexiscan	Regadenoson	Astellas	Baxter
05/24/2023	Tapazole	Methimazole	King Pharms	Macleods
05/24/2023	Gilenya	Fingolimod HCl	Novartis	Bionpharma
05/24/2023	Zemuron	Rocuronium Bromide	Organon	Hikma
05/24/2023	Metronidazole	Metronidazole	Hospira	Amneal
05/25/2023	Orfadin	Nitisinone	Swedish Orphan	Zenara
05/25/2023	Hemabate	Carboprost Tromethamine	Pfizer	Eugia Pharma
05/26/2023	Renagel	Sevelamer HCl	Genzyme	Macleods Pharms
05/26/2023	Eliquis	Apixaban	Bristol-Myers Squibb	Aurobindo
05/26/2023	Vasostrict	Vasopressin	Endo / Par	Fresenius Kabi
05/26/2023	Timoptic	Timolol Maleate	Bausch and Lomb	Micro Labs
05/30/2023	Diastat Acudial	Diazepam	Bausch	Novel Labs
05/30/2023	Ocalvia	Obeticholic Acid	Intercept	Apotex
05/30/2023	Ocaliva	Obeticholic Acid	Intercept	Lupin
05/30/2023	Ocaliva	Obeticholic Acid	Intercept	MSN
05/30/2023	Rowasa	Mesalamine	Mylan Speciality	Encube
05/31/2023	Aczone	Dapsone	Almirall	Amneal
05/31/2023	Esbriet	Pirfenidone	Genentech	Apotex
05/31/2023	Iressa	Gefitinib	AstraZeneca	Natco
05/31/2023	Wellbutrin	Bupropion HCl	GlaxoSmithKline	Annora Pharma
05/31/2023	EC-Naprosyn	Naproxen	Atnahs Pharma	Tulex Pharms
06/01/2023	Benicar HCT	Olmesartan Medoxomil / Hydrochlorothiazide	Cosette	Macleods
06/01/2023	Cellcept	Mycophenolate Mofetil HCl	Roche	Bpi Labs
06/01/2023	Lyrica CR	Pregabalin	Upjohn	Sinotherapeutics
06/01/2023	Bentyl	Dicyclomine HCl	Allergan	Twi
06/02/2023	Corgard	Nadolol	USWM	Alembic
06/02/2023	Inspira	Eplerenone	Upjohn	Annora Pharma
06/02/2023	Arranon	Nelarabine	Sandoz	Nexus Pharms
06/05/2023	Treanda	Bendamustine HCl	Cephalon	Apotex
06/05/2023	Treanda	Bendamustine HCl	Cephalon	Kindos
06/05/2023	Reclast	Zoledronic Acid	Sandoz	Hong Kong
06/05/2023	Foscavir	Foscarnet Sodium	Clinigen Healthcare	Avet Lifesciences
06/05/2023	Treanda	Bendamustine HCl	Cephalon	Eugia Pharma
06/06/2023	Vesicare	Solifenacin Succinate	Astellas	Lannett
06/06/2023	Adcirca	Tadalafil	Eli Lilly	Zydus
06/06/2023	Aczone	Dapsone	Almirall (Allergan)	Acrux Dds
06/06/2023	Lovenox	Enoxaparin Sodium	Sanofi Aventis	Be Pharms
06/06/2023	Apriso	Mesalamine	Valeant Pharms	Amta
06/07/2023	Nexium	Esomeprazole Magnesium	AstraZeneca	Zydus
06/07/2023	Treanda	Bendamustine HCl	Cephalon	Nang Kuang Pharm
06/07/2023	Depo-Provera	Medroxyprogesterone Acetate	Pfizer	Amneal
06/07/2023	Precedex	Dexmedetomidine HCl	Hospira	Milla Pharms
06/07/2023	Mobic	Meloxicam	Boehringer Ingelheim	Ascent Pharms
06/08/2023	Fleqsuvy	Baclofen	Azurity	Slayback Pharma
06/08/2023	Colazel	Balsalazide Disodium	Valeant Pharms	Zydus
06/09/2023	Latuda	Lurasidone HCl	Sunovion	Macleods
06/09/2023	Esbriet	Pirfenidone	Genentech	Apotex
06/09/2023	Bridion	Sugammadex Sodium	Merck	Aspiro
06/09/2023	Ciprodex	Ciprofloxacin / Dexamethasone	Novartis	Akorn
06/09/2023	Nimbex	Cisatracurium Besylate	Abbvie	Caplin
06/12/2023	Athrotec	Diclofenac Sodium / Misoprostol	Pfizer	Zydus
06/12/2023	Chantix	Varenicline Tartrate	Pfizer	Zydus
06/12/2023	Toprol-XL	Metoprolol Succinate	Toprol	Granules
06/13/2023	Lonsurf	Tipiracil HCl / Trifluridine	Taiho Oncology	Natco
06/13/2023	Katerzia	Amlodipine Benzoate	Azurity	Amneal
06/13/2023	Sandostatin	Octreotide Acetate	Novartis	Gland Pharma
06/13/2023	Keppra	Levetiracetam	UCB	Granules
06/14/2023	Xadago	Safinamide Mesylate	MDD US	Aurobindo
06/14/2023	Nasonex 24 Hr Allegy	Mometasone Furoate	Perrigo	Amneal
06/15/2023	Bridion	Sugammadex Sodium	Merck	Mylan
06/15/2023	Hectorol	Doxercalciferol	Sanofi	Alembic
06/15/2023	Sodium Bicarbonate	Sodium Bicarbonate	Abbott Labs	Omnivium Pharms
06/15/2023	Hemabate	Carboprost Tromethamine	Pfizer	Alembic
06/16/2023	Solodyn	Minocycline HCl	Bausch	Zydus
06/16/2023	MetroGel-Vaginal	Metronidazole	Bausch	Encube
06/16/2023	Protonix	Pantoprazole Sodium	Wyeth	Dexcel
06/16/2023	Klor-Con	Potassium Chloride	Upsher-Smith	Rubicon
06/16/2023	Banzel	Rufinamide	Eisai	Aurobindo
06/16/2023	Pepcid	Famotidine	Johnson & Johnson	Appco
06/16/2023	Xylocaine	Lidocaine HCl	Fresenius Kabi	Mankind Pharma
06/16/2023	Lodoco	Colchicine	Agepha Pharma	Agepha Pharma
06/20/2023	Dibenzyline	Phenoxybenzamine HCl	Concordia	Rising
06/20/2023	Spiriva HandiHaler	Tiotropium Bromide	Boehringer Ingelheim	Lupin
06/20/2023	Glumetza	Metformin HCl	Santarus	Vgyaan
06/20/2023	Noxafil	Posaconazole	Merck	Welding
06/20/2023	Toradol	Ketorolac Tromethamine	Roche	Aspiro
06/20/2023	Trokendi XR	Topiramate	Supernus	Alkem Labs
06/21/2023	Samsca	Tolvaptana	Otsuka	MSN
06/21/2023	Nebcin	Tobramycin Sulfate	Eli Lilly	Eugia Pharma
06/22/2023	Adzenys SR-ODT	Amphetamine	Neos Theraps	Actavis
06/22/2023	Sandostatin	Octreotide Acetate	Novartis	Gland Pharma
06/22/2023	Migranal	Dihydroergotamine Mesylate	Bausch	Rubicon
06/23/2023	Lastacaft	Alcaftadine	AbbVie	Eugia Pharma
06/23/2023	Bridion	Sugammadex Sodium	Merck	Sandoz
06/23/2023	Sensorcaine	Bupivacaine Hydrochloride	Fresenius Kabi	Kindos
06/26/2023	Phenylphrine HCl	Phenoxybenzamine HCl	Hikma	Be Pharms
06/27/2023	Sinequan	Doxepin HCl	Pfizer	Micro Labs
06/28/2023	Vidaza	Azacitidine	Bristol-Myers Squibb	Jiangsu Hansoh
06/29/2023	Nuvaring	Etonogestrel / Ethinyl Estradiol	Merck	Xiromed
06/29/2023	Sabril	Vigabatrin	Lundbeck	Zenara
06/29/2023	Vancomycin HCl	Vancomycin HCl	Mylan	Hikma
06/30/2023	Nascobal	Cyanocobalamin	Endo	Lupin
06/30/2023	Activella	Estradiol / Norethindrone Acetate	Amneal	Aurobindo
06/30/2023	Faslodex	Fulvestrant	AstraZeneca	Eugia Pharma