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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 | NDA Holder | ANDA Applicant |
|---|---|---|---|---|
| 01/03/2022 | Esbriet | Pirfenidone | Genentech | Amneal |
| 01/03/2022 | Doryx | Doxycycline Hyclate | Mayne | Alembic Pharms |
| 01/03/2022 | Rapaflo | Silodosin | AbbVie | Upsher Smith |
| 01/04/2022 | Vesicare | Solifenacin Succinate | Astellas | Accord Healthcare |
| 01/04/2022 | Rapaflo | Silodosin | AbbVie | Prinston |
| 01/04/2022 | Toprol XL | Metoprolol Succinate | AstraZeneca | Prinston |
| 01/04/2022 | Comtan | Entacapone | Orion | Alembic Pharms |
| 01/04/2022 | Migranal | Dihydroergotamine Mesylate | Bausch | Amneal |
| 01/04/2022 | Effexor ER | Venlafaxine HCl | Wyeth | Pharmadax |
| 01/05/2022 | Tamiflu | Oseltamivir Phosphate | Roche | Sunshine |
| 01/05/2022 | Progesterone | Progesterone | Actavis | Xiromed |
| 01/05/2022 | Zytiga | Abiraterone Acetate | Johnson & Johnson | Oncogen Pharma |
| 01/06/2022 | Colcrys | Colchicine | Takeda | Aurobindo |
| 01/07/2022 | Pepcid | Famotidine | Bausch | VKT |
| 01/10/2022 | Transderm Scop | Scopolamine | Baxter Healthcare | Actavis Labs |
| 01/11/2022 | Trileptal | Oxcarbazepine | Novartis | Annora Pharma |
| 01/12/2022 | Morphine Sulfate | Morphine Sulfate | Hikma | Mayne Pharma |
| 01/13/2022 | Tamiflu | Oseltamivir Phosphate | Roche | Strides |
| 01/13/2022 | Potassium Chloride | Potassium Chloride | Genus | Rubicon |
| 01/14/2022 | Differin | Adapalene | Galderma | Taro Pharms |
| 01/18/2022 | Amitiza | Lubiprostone | Sucampo | Teva |
| 01/18/2022 | Cleocin T | Clindamycin Phosphate | Pfizer | Encube |
| 01/19/2022 | Kenalog 40 | Triamcinolone Acetonide | Apothecon | Custopharm / Long Grove Pharms |
| 01/19/2022 | Ranexa | Ranolazine | Gilead | VKT Pharma |
| 01/19/2022 | Floxin Otic | Ofloxacin | Daiichi Sankyo | FDC |
| 01/19/2022 | Sabril | Vigabatrin | Lundbeck | Zydus |
| 01/20/2022 | Esbriet | Pirfenidone | Genentech | Accord Healthcare |
| 01/21/2022 | Welchol | Colesevelam HCl | Daiichi Sankyo | SPH |
| 01/21/2022 | Depo Medrol | Methylprednisolone Acetate | Pfizer | Par |
| 01/21/2022 | Questran | Cholestyramine | Bristol-Myers Squib | Upsher Smith |
| 01/24/2022 | Atripla | Efavirenz / Emtricitabine / Tenofovir Disoproxil Fumarate | Gilead | Hetero Labs |
| 01/24/2022 | Fosrenol | Lanthanum Carbonate | Takeda | Invagen Pharms |
| 01/24/2022 | Hectorol | Doxercalciferol | Genzyme | Aurobindo / Eugia Pharma |
| 01/25/2022 | Hygroton | Chlorthalidone | Sanofi Aventis | Sunny |
| 01/25/2022 | Cellcept | Mycophenolate Mofetil | Roche | Teva |
| 01/25/2022 | Esbriet | Pirfenidone | Genentech | Accord Healthcare |
| 01/25/2022 | Esbriet | Pirfenidone | Genentech | Teva |
| 01/25/2022 | Stalevo | Carbidopa / Levodopa / Entacapone | Orion | Rising |
| 01/25/2022 | Lioresal | Baclofen | Novartis | Mankind Pharma |
| 01/25/2022 | Cosopt | Dorzolamide HCl / Timolol Maleate | Akorn | Micro Labs |
| 01/26/2022 | Pomalyst | Pomalidomide | Celgene | Mylan |
| 01/26/2022 | Monurol | Fosfomycin Tromethamine | AbbVie | Cipla |
| 01/26/2022 | Aloprim | Allopurinol | Mylan | Gland Pharma |
| 01/26/2022 | Potassium Chloride | Potassium Chloride | Genus | Tris Pharma |
| 01/26/2022 | Fioricet with codeine | Butalbital / Acetaminophen / Caffeine / Codeine Phosphate | Teva | Hikma |
| 01/26/2022 | Atropine sulfate | Atropine Sulfate | Hospira | Amneal |
| 01/26/2022 | Ziac | Bisoprolol Fumarate / Hydrochlorothiazide | Teva | Glenmark |
| 01/27/2022 | Fosrenol | Lanthanum Carbonate | Takeda | Barr |
| 01/27/2022 | Sovaldi | Sofosbuvir | Gilead | Teva |
| 01/27/2022 | Lasix | Furosemide | Sanofi Aventis | Hong Kong |
| 01/27/2022 | Klor-con | Potassium Chloride | Upsher-Smith | Granules |
| 01/27/2022 | Chlorpromazine HCl | Chlorpromazine HCl | Upsher-Smith | MSN Labs |
| 01/27/2022 | Hemabate | Carboprost Tromethamine | Pfizer | Amneal |
| 01/27/2022 | Trusopt | Dorzolamide HCl | Merck | Gland Pharma |
| 01/27/2022 | Metrogel-Vaginal | Metronidazole | Bausch | Glenmark |
| 01/28/2022 | Zioptan | Tafluprost | Akorn | Sandoz |
| 01/28/2022 | Cystadane | Betaine | Recordati | Lukare Medical |
| 01/28/2022 | Pepcid AC | Famotidine | Johnson & Johnson | Vkt Pharma |
| 01/31/2022 | Qoliana / Alphagan P | Brimonidine Tartrate | Sandoz / Allergan | Apotex |
| 01/31/2022 | Biaxin | Clarithromycin | AbbVie | Alembic Pharms |
| 01/31/2022 | Adderall XR | Dextroamp Saccharate / Amp Aspartate / Dextroamp Sulfate / Amp Sulfate | Takeda | Teva |
| 02/01/2022 | Mucinex D | Guaifenesin / Pseudoephedrine HCl | Reckitt | Padagis |
| 02/02/2022 | Restasis | Cyclosporine | AbbVie | Mylan |
| 02/02/2022 | Excedrin Migraine | Acetaminophen / Aspirin / Caffeine | Glaxo | Aurobindo |
| 02/02/2022 | Limbitrol | Chlordiazepoxide / Amitriptyline HCl | Heritage | Micro Labs |
| 02/02/2022 | Reyataz | Atazanavir Sulfate | Bristol-Myers Squib | Hetero Labs |
| 02/02/2022 | Wellbutrin XL | Bupropion HCl | Bausch | Granules |
| 02/03/2022 | Zavesca | Miglustat | Actelion | Breckenridge |
| 02/03/2022 | Vidaza | Azacitidine | Celgene | Amneal |
| 02/03/2022 | Mirapex ER | Pramipexole Dihydrochloride | Boehringer Ingelheim | Novast Labs |
| 02/03/2022 | Acetadote | Acetylcysteine | Cumberland | Aspen |
| 02/03/2022 | Lamictal ODT | Lamotrigine | Glaxo | Amring Pharms |
| 02/04/2022 | Aczone 7.5% gel | Dapsone | Almirall | Mylan |
| 02/04/2022 | Noxafil | Posaconazole | Merck | Biocon Pharma |
| 02/07/2022 | Selzentry | Maraviroc | ViiV | Hetero Labs |
| 02/07/2022 | Brovana | Arformoterol Tartrate | Mylan | Lupin |
| 02/07/2022 | Renvela | Sevelamer Carbonate | Sanofi | Micro Labs |
| 02/07/2022 | Morphine Sulfate | Morphine Sulfate | Hikma | Riconpharma |
| 02/07/2022 | Anectine / Quelicin | Succinylcholine Chloride | Sandoz / Hospira | Be Pharms |
| 02/08/2022 | Amitiza | Lubiprostone | Sucampo | Dr Reddys Labs |
| 02/08/2022 | Revex | Nalmefene HCl | Eurohealth | Purdue Pharma |
| 02/08/2022 | Bactrim | Sulfamethoxazole / Trimethoprim | Sun Pharma | Novitium Pharma |
| 02/08/2022 | Revatio | Sildenafil Citrate | Viatris | MSN Labs |
| 02/08/2022 | Lanoxin | Digoxin | Advanz | Aurobindo |
| 02/09/2022 | Chlorthalidone | Chlorthalidone | Mylan | Inventia |
| 02/09/2022 | Sinequan | Doxepin HCl | Pfizer | Mankind Pharma |
| 02/10/2022 | Daliresp | Roflumilast | AstraZeneca | Zydus |
| 02/10/2022 | Veltin gel | Clindamycin Phosphate / Tretinoin | Almirall | Solaris Pharma |
| 02/10/2022 | Faslodex | Fulvestrant | AstraZeneca | Jiangsu Hansoh Pharm |
| 02/10/2022 | Aczone 7.5% gel | Dapsone | Almirall | Torrent |
| 02/10/2022 | Nexium IV | Esomeprazole Sodium | AstraZeneca | Hainan Poly |
| 02/11/2022 | Tobradex | Tobramycin / Dexamethasone | Novartis | Padagis |
| 02/14/2022 | Erythrocin | Erythromycin Lactobionate | Hospira | Nexus Pharms |
| 02/15/2022 | Samsca | Tolvaptan | Otsuka | Par |
| 02/15/2022 | Vancomycin HCl | Vancomycin HCl | Baxter | Knack |
| 02/16/2022 | Sanctura | Trospium Chloride | Allergan | Amici |
| 02/17/2022 | Antivert | Meclizine HCl | Casper | Cipla |
| 02/17/2022 | Valcyte | Valganciclovir HCl | Roche | Airis Pharma |
| 02/17/2022 | Embeline | Clobetasol Propionate | Akorn | Solaris Pharma |
| 02/18/2022 | Macrobid | Nitrofurantoin Monohydrate / Macrocrystals | Almatica | Inventia |
| 02/18/2022 | Symmetrel | Amantadine HCl | Endo | Strides |
| 02/18/2022 | Lyrica | Pregabalin | Pfizer | Invatech |
| 02/18/2022 | Cardioplegic / Plegisol | Cardioplegic / Plegisol | Hospira | Fresenius Kabi USA |
| 02/18/2022 | Betamethasone Dipropionate | Betamethasone Dipropionate | Fougera Pharms | Tasman Pharma |
| 02/18/2022 | Testred | Methyltestosterone | Bausch | Novitium Pharma |
| 02/22/2022 | Farxiga | Dapagliflozin | AstraZeneca | Zydus |
| 02/22/2022 | Fortamet | Metformin HCl | Teva | Sciegen Pharms |
| 02/23/2022 | Apokyn | Apomorphine HCl | Supernus | Sage Chems |
| 02/23/2022 | Jadenu Sprinkle | Deferasirox | Novartis | Cipla |
| 02/23/2022 | Acetadote | Acetylcysteine | Cumberland | Indoco |
| 02/23/2022 | Maxzide | Triamterene / Hydrochlorothiazide | Mylan | Rubicon |
| 02/24/2022 | Chlorthalidone | Chlorthalidone | Mylan | Tagi |
| 02/24/2022 | Epaned | Enalapril Maleate | Azurity | Annora Pharma |
| 02/25/2022 | Depakote ER | Divalproex Sodium | AbbVie | Unichem |
| 02/25/2022 | Akovaz | Ephedrine Sulfate | Exela | Gland Pharma |
| 02/28/2022 | Cytarabine | Cytarabine | Teva | Hong Kong |
| 02/28/2022 | Tamiflu | Oseltamivir Phosphate | Roche | Leading Pharma |
| 02/28/2022 | Navane | Thiothixene | Pfizer | Amneal |
| 03/01/2022 | Bonjesta | Doxylamine Succinate / Pyridoxine HCl | Duchesnay | Actavis Labs |
| 03/02/2022 | Jublia | Efinaconazole | Bausch | Lupin |
| 03/02/2022 | Brovana | Arformoterol Tartrate | Mylan | Vistapharm |
| 03/03/2022 | Niaspan | Niacin | AbbVie | Macleods |
| 03/04/2022 | Mykacet | Nystatin / Triamcinolone Acetonide | Cosette | Aleor Dermaceuticals |
| 03/04/2022 | Cambia | Diclofenac Potassium | Assertio | Annora Pharma |
| 03/07/2022 | Zyloprim | Allopurinol | Casper | Harman Finochem |
| 03/08/2022 | Nitrostat | Nitroglycerin | Viatris | Zydus |
| 03/08/2022 | Lyrica | Pregabalin | Pfizer | Eskayef |
| 03/10/2022 | Colcrys | Colchicine | Takeda | Strides |
| 03/10/2022 | Sabril | Vigabatrin | Lundbeck | Lupin |
| 03/10/2022 | Nilstat | Nystatin | Glenmark | Medley |
| 03/10/2022 | Colestid | Colestipol HCl | Pfizer | Zydus |
| 03/11/2022 | Nimbex | Cisatracurium Besylate | AbbVie | Piramal Healthcare |
| 03/11/2022 | Digoxin | Digoxin | Hikma | Amici |
| 03/14/2022 | Daytrana | Methylphenidate | Noven | Mylan |
| 03/14/2022 | Sinequan | Doxepin HCl | Pfizer | Jubilant Cadista |
| 03/15/2022 | Breyna | Budesonide / Formoterol Fumarate Dihydrate | AstraZeneca | Mylan |
| 03/15/2022 | Carafate | Sucralfate | AbbVie | Vistapharm |
| 03/15/2022 | Cardura | Doxazosin Mesylate | Viatris | Method |
| 03/15/2022 | Bystolic | Nebivolol HCl | AbbVie | Unichem |
| 03/15/2022 | Mucinex | Guaifenesin | Reckitt Benckiser | Dr Reddys Labs |
| 03/17/2022 | Vimpat | Lacosamide | UCB | Hetero Labs |
| 03/17/2022 | Vimpat | Lacosamide | UCB | Amneal |
| 03/17/2022 | Vimpat | Lacosamide | UCB | MSM Labs |
| 03/17/2022 | Vimpat | Lacosamide | UCB | Alembic |
| 03/17/2022 | Vimpat | Lacosamide | UCB | Glenmark |
| 03/17/2022 | Vimpat | Lacosamide | UCB | Sun Pharm |
| 03/17/2022 | Vimpat | Lacosamide | UCB | Sciegen Pharms |
| 03/17/2022 | Pentam | Pentamidine Isethionate | Fresenius Kabi | Xgen Pharms |
| 03/17/2022 | Vimpat | Lacosamide | UCB | Indoco |
| 03/17/2022 | Isoptin | Verapamil HCl | Mt Adams Technologies | Acic Pharms |
| 03/18/2022 | Xibrom | Bromfenac Sodium | Bausch | Eugia Pharma |
| 03/21/2022 | Sklice | Ivermectin | Arbor | Teva |
| 03/21/2022 | Kaletra | Lopinavir / Ritonavir | AbbVie | Laurus |
| 03/21/2022 | Brevibloc | Esmolol HCl | Baxter | Eugia Pharma |
| 03/22/2022 | Lyrica CR | Pregabalin | Pfizer | Rubicon |
| 03/23/2022 | Revatio | Sildenafil Citrate | Viatris | Lupin |
| 03/23/2022 | Inspra | Eplerenone | Pfizer | Kartha |
| 03/23/2022 | Amicar | Aminocaproic Acid | Akorn | Agenix |
| 03/23/2022 | Toradol | Ketorolac Tromethamine | Roche | Havix (Senores) |
| 03/23/2022 | Laying-O-Jet Kit | Lidocaine HCl | Amphastar | Novitium Pharma |
| 03/24/2022 | Klor-con | Potassium Chloride | Upsher-Smith | Rubicon |
| 03/24/2022 | Onfi | Clobazam | Lundbeck | Aurobindo |
| 03/25/2022 | Esbriet | Pirfenidone | Genentech | Amneal |
| 03/25/2022 | Butalbital / Acetaminophen / Caffeine | Butalbital / Acetaminophen / Caffeine | Gilbert | Hikma |
| 03/28/2022 | Uloric | Febuxostat | Takeda | Prinston |
| 03/28/2022 | Keppra | Levetiracetam | UCB | Prinston |
| 03/28/2022 | Tamiflu | Oseltamivir Phosphate | Roche | Hetero Labs |
| 03/28/2022 | Dextrose 5% and Lactated Ringer's | Dextrose 5% and Lactated Ringer's | ICU Medical | Fresenius Kabi USA |
| 03/28/2022 | Prednisone | Prednisone | Hikma | Aurobindo |
| 03/29/2022 | Procardia XL | Nifedipine | Pfizer | Alkem Labs |
| 03/29/2022 | Prozac | Fluoxetine HCl | Eli Lilly | Micro Labs |
| 03/30/2022 | Sodium Phosphates | Sodium Phosphates | Hospira | Fresenius Kabi USA |
| 03/30/2022 | Lymepak | Doxycycline Hyclate | Chartwell | Praxgen |
| 03/30/2022 | Epaned O.S. | Enalapril Maleate | Azurity | Alkem Labs |
| 03/30/2022 | Datscan | Ioflupane I-123 | GE Healthcare | Curium |
| 03/30/2022 | Motrin | Ibuprofen | McNeil | Yichang Humanwell |
| 03/31/2022 | Aczone | Dapsone | AbbVie | SeegPharm |
| 03/31/2022 | Bystolic | Nebivolol HCl | AbbVie | Ajanta |
| 03/31/2022 | Vimpat | Lacosamide | UCB | Alkem Labs |
| 03/31/2022 | Tegretol XR | Carbamazepine | Novartis | Zhejiang Jiuzhou |
| 03/31/2022 | Zovirax | Acyclovir | Mylan | Aurobindo |
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