New Drug Applications and 505(b)(2) Applications
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 |
|---|---|---|---|---|
| 07/01/2022 | Haldol | Haloperidol | Ortho McNeil | Actavis |
| 07/01/2022 | Zovirax | Acyclovir | Mylan | Hetero Labs |
| 07/05/2022 | Adderall | Dextroamp Saccharate / Amp Aspartate / Dextroamp Sulfate / Amp Sulfate | Teva | Cediprof |
| 07/05/2022 | Kenalog-40 | Triamcinolone Acetonide | Apothecon | Eugia Pharma |
| 07/05/2022 | Cuyposa | Glycopyrrolate | Merz | Suven Pharms |
| 07/05/2022 | Cuyposa | Glycopyrrolate | Merz | Annora Pharma |
| 07/06/2022 | Dyrenium | Triamterene | Concordia | Eywa |
| 07/06/2022 | Bloxiverz | Neostigmine Methylsulfate | Exela | Dr Reddy's Labs |
| 07/07/2022 | Synjardy | Empagliflozin / Metformin HCl | Boehringer-Ingelheim | Zydus |
| 07/07/2022 | Vasotec | Enalapril Maleate | Bausch | Prinston |
| 7/8/2022 | Adderall | Dextroamp Saccharate / Amp Aspartate / Dextroamp Sulfate / Amp Sulfate | Teva | Lannett |
| 07/08/2022 | Isordil | Isosorbide Dinitrate | Bausch | Rubicon |
| 07/12/2022 | Vimpat | Lacosamide | UCB | Accord Healthcare |
| 07/12/2022 | Lexiscan | Regadenoson | Astellas | Gland Pharma |
| 07/12/2022 | Zithromax | Azithromycin | Pfizer | ACI |
| 07/13/2022 | Nystatin | Nystatin / Triamcinolone Acetonide | Cossette | Macleods |
| 07/13/2022 | Relpax | Eletriptan Hydrobromide | Pfizer | Beximco Pharms |
| 07/13/2022 | Neostigmine Methylsulfate | Neostigmine Methylsulfate | Fresenius Kabi | Hikma |
| 07/14/2022 | Ditropan | Oxybutynin Chloride | Janssen | Beximco Pharms |
| 07/14/2022 | Compazine | Prochlorperazine Edisylate | GlaxoSmithKline | Eugia Pharma |
| 07/14/2022 | Atropine Sulfate | Atropine Sulfate | Akorn | Amneal |
| 07/14/2022 | Robaxin | Methocarbamol | Hikma | Baxter Healthcare |
| 07/14/2022 | Floxin Otic | Ofloxacin | Bausch | Mankind |
| 07/15/2022 | Jublia | Efinaconazole | Bausch | Zydus |
| 07/15/2022 | Keppra | Levetiracetam | UCB | MSN |
| 07/15/2022 | Zithromax | Azithromycin | Pfizer | ACI |
| 07/15/2022 | Prolixin | Fluphenazine HCl | Bristol Myers Squibb | Apotex |
| 07/18/2022 | Vasostrict | Vasopressin | Par | Amphastar Pharms |
| 07/18/2022 | Prepopik | Sodium Picosulfate / Magnesium Oxide / Anhydrous Citric Acid | Ferring | Hetero Labs |
| 07/18/2022 | Nalfon | Fenoprofen Calcium | Xspire | Rising |
| 07/18/2022 | Lyrica | Pregabalin | Pfizer | Marksans Pharma |
| 07/19/2022 | Esbriet | Pirfenidone | Genentech | Laurus |
| 07/19/2022 | Dibenzyline | Phenoxybenzamine HCl | Concordia | Novitium Pharma |
| 07/19/2022 | Librax | Chlordiazepoxide HCl / Clidinium Bromide | Bausch | Micro Labs |
| 07/19/2022 | Levophed | Norepinephrine Bitartrate | Hospira | Zydus |
| 07/20/2022 | Edarbi | Azilsartan Medoxomil | Azurity | Lupin |
| 07/20/2022 | Macrobid | Nitrofurantoin Monohydrate / Macrocrystals | Alamatica | Alvogen |
| 07/20/2022 | Cambia | Diclofenac Potassium | Assertio | Alkem Labs |
| 07/21/2022 | Esbriet | Pirfenidone | Genentech | Aizant |
| 07/21/2022 | Letairis | Ambrisentan | Gilead | Aurobindo |
| 07/22/2022 | Minocin | Minocycline HCl | Melinta | Nexus Pharms |
| 07/25/2022 | Tamiflu | Oseltamivir Phosphate | Roche | Accord Healthcare |
| 07/25/2022 | Zebeta | Bisoprolol Fumarate | Teva | Cadila |
| 07/25/2022 | K-Tab | Potassium Chloride | AbbVie | Rubicon |
| 07/25/2022 | Epzicom | Abacavir Sulfate / Lamivudine | ViiV | Laurus |
| 07/26/2022 | Velcade | Bortezomib | Takeda | Dr Reddy's Labs |
| 07/26/2022 | Velcade | Bortezomib | Takeda | Sandoz |
| 07/26/2022 | Velcade | Bortezomib | Takeda | Accord Healthcare |
| 07/26/2022 | Velcade | Bortezomib | Takeda | Hospira |
| 07/26/2022 | Velcade | Bortezomib | Takeda | MSN |
| 07/26/2022 | Zetia | Ezetimibe | Organon | Hetero Labs |
| 07/26/2022 | Zithromax | Azithromycin | Pfizer | Yung Shin Pharm |
| 07/26/2022 | Velcade | Bortezomib | Takeda | Meitheal |
| 07/26/2022 | Velcade | Bortezomib | Takeda | Jiangsu Hansoh Pharm |
| 07/26/2022 | Protonix | Pantoprazole Sodium | Wyeth | Mankind |
| 07/27/2022 | Solaraze | Diclofenac Sodium | Novartis / Fougera | Aleor Dermaceuticals |
| 07/27/2022 | Taytulla | Norethindrone Acetate / Ethinyl Estradiol / Ferrous Fumarate | AbbVie | Glenmark |
| 07/27/2022 | Ofirmev | Acetaminophen | Mallinckrodt | Aspiro |
| 07/29/2022 | Librax | Chlordiazepoxide HCl / Clidinium Bromide | Bausch | Westminster Pharms |
| 08/01/2022 | Esbriet | Pirfenidone | Genentech | ScieGen Pharms |
| 08/02/2022 | Soolantra | Ivermectin | Galderma | Zydus |
| 08/02/2022 | Neoral | Cyclosporine | Novartis | Strides Pharma |
| 08/03/2022 | Jardiance | Empagliflozin | Boehringer-Ingelheim | Zydus |
| 08/03/2022 | Bactroban | Mupirocin | GlaxoSmithKline | Padagis |
| 08/04/2022 | Alimta | Pemetrexed Disodium | Eli Lilly | Amneal |
| 08/04/2022 | Epiduo Porte | Adapalene / Benzoyl Peroxide | Galderma | Aleor Dermaceuticals |
| 08/04/2022 | Bumex | Bumetanide | Validus | MSN |
| 08/04/2022 | Chlorthalidone | Chlorthalidone | Mylan | Mankind Pharma |
| 08/04/2022 | Pepcid | Famotidine | Salix | Amneal |
| 08/05/2022 | Nuvaring | Ethinyl Estradiol / Etonogestrel | Organon | Mayne Pharma |
| 08/05/2022 | Vasostrict | Vasopressin | Endo / Par | Amneal |
| 08/05/2022 | Clindagel | Clindamycin Phosphate | Bausch | Amneal |
| 08/08/2022 | Trandate | Labetalol HCl | Alvogen | Unichem |
| 08/08/2022 | Decadron | Dexamethasone | Merck | Novitium Pharma |
| 08/08/2022 | Cardizem CD | Diltiazem HCl | Bausch | Amta |
| 08/08/2022 | Procomp | Prochlorperazine Maleate | Jubilant | Zydus |
| 08/09/2022 | Hemabate | Carboprost Tromethamine | Pfizer | Long Grove Pharms |
| 08/10/2022 | Divigel | Estradiol | Vertical | Chemo Research |
| 08/11/2022 | Antivert | Meclizine HCl | Casper | Lupin |
| 08/11/2022 | Adcirca/Cialis | Tadalafil | Eli Lilly | Prinston |
| 08/11/2022 | Rexulti | Brexpiprazole | Otsuka | Teva |
| 08/12/2022 | Cetrotide | Cetrorelix Acetate | Merck Serono | Akorn |
| 08/15/2022 | Vasostrict | Vasopressin | Endo / Par | Eugia Pharma |
| 08/15/2022 | Seroquel XR | Quetiapine Fumarate | AstraZeneca | Unichem |
| 08/16/2022 | Atrovent | Ipratropium Bromide | Boehringer-Ingelheim | Amneal |
| 08/17/2022 | Banzel | Rufinamide | Eisai | Lupin |
| 08/17/2022 | Cerdelga | Eliglustat Tartrate | Celgene | Dr Reddy's Labs |
| 08/17/2022 | Naproxen | Naproxen Sodium | Bionpharma | Strides Pharma |
| 08/18/2022 | Dextrostat | Dextroamphetamine Sulfate | Shire | Tris Pharma |
| 08/18/2022 | Pennsaid 2% | Diclofenac Sodium | Horizon | Amneal |
| 08/18/2022 | Naropin | Ropivacaine HCl | Fresenius Kabi | Gland Pharma |
| 08/18/2022 | Otezla | Apremilast | Amgen | Teva |
| 08/18/2022 | Alimta | Pemetrexed Disodium | Eli Lilly | Baxter Healthcare |
| 08/18/2022 | Kuvan | Sapropterin Dihydrochloride | Biomarin | Annora Pharma |
| 08/18/2022 | Zovirax | Acyclovir | Mylan | Rubicon |
| 08/18/2022 | Cubicin | Daptomycin | Cubist | Hainan Poly Pharm |
| 08/18/2022 | Merrem | Meropenem | Pfizer | Brooks Steriscience |
| 08/18/2022 | Tegretol XR | Carbamazepine | Novartis | Umedica Labs |
| 08/19/2022 | Riomet | Metformin HCl | Sun | Vistapharm |
| 08/19/2022 | DDAVP | Desmopressin Acetate | Ferring | Dr Reddy's Labs |
| 08/22/2022 | Fentora | Fentanyl Citrate | Teva | Mayne Pharma |
| 08/22/2022 | Zyvox | Linezolid | Pfizer | Hikma |
| 08/22/2022 | Depo-Provera | Medroxyprogesterone Acetate | Pfizer | Eugia Pharma |
| 08/22/2022 | Tegretol | Carbamazepine | Novartis | Unichem |
| 08/22/2022 | Brovana | Formoterol Fumarate | Mylan | Lupin |
| 08/22/2022 | Mucinex D | Guaifenesin / Pseudoephedrine HCl | Indivior | Granules |
| 08/23/2022 | Kuvan | Sapropterin Dihydrochloride | Biomarin | Annora Pharma |
| 08/24/2022 | Vimovo | Naproxen / Esomeprazole Magnesium | Horizon | Actavis |
| 08/24/2022 | Seroquel | Quetiapine Fumarate | AstraZeneca | Prinston |
| 08/24/2022 | Rozerem | Ramelteon | Takeda | Enaltec |
| 08/25/2022 | Accolate | Zafirlukast | Strides | Rising Pharms |
| 08/25/2022 | Toradol | Ketorolac Tromethamine | Roche | Hetero Labs |
| 08/26/2022 | Mexitil | Mexiletine HCl | Boehringer-Ingelheim | Aucta |
| 08/26/2022 | Lyrica CR | Pregabalin | Zydus | Zydus |
| 08/26/2022 | Nipride | Sodium Nitroprusside | Exela | Hainan Poly |
| 08/26/2022 | Vimpat | Lacosamide | UCB | Novitium Pharma |
| 08/26/2022 | Chlorthalidone | Chlorthalidone | Mylan | Alembic Pharms |
| 08/29/2022 | Sabril | Vigabatrin | Lundbeck | Hikma |
| 08/29/2022 | Protonix IV | Pantoprazole Sodium | Wyeth | Nanjing King-Friend |
| 08/29/2022 | Imodium | Loperamide HCl / Simethicone | Johnson & Johnson | Granules |
| 08/30/2022 | Revlimid | Lenalidomide | Celgene | Dr Reddy's Labs |
| 08/30/2022 | Ciprodex | Ciprofloxacin / Dexamethasone | Novartis | Sun Pharm |
| 08/30/2022 | Revlimid | Lenalidomide | Celgene | Apotex |
| 08/30/2022 | Revlimid | Lenalidomide | Celgene | Mylan |
| 08/30/2022 | Venlafaxine HCl | Venlafaxine HCl | Osmotica | Zydus |
| 08/30/2022 | Trileptal | Oxcarbazepine | Novartis | Rubicon |
| 08/30/2022 | Vazculep | Phenylephrine HCl | Exela | Mankind |
| 08/31/2022 | Revlimid | Lenalidomide | Celgene | Lotus Pharm |
| 08/31/2022 | Depo-Provera | Medroxyprogesterone Acetate | Pfizer | Eugia Pharma |
| 08/31/2022 | Lexiscan | Regadenoson | Astellas | Hospira |
| 09/01/2022 | Lyrica | Pregabalin | Upjohn | Prinston |
| 09/01/2022 | Adempas | Riociguat | Bayer | MSN |
| 09/02/2022 | Tri-Lo-Linyah | Ethinyl Estradiol / Norgestimate | Johnson & Johnson | Novast Labs |
| 09/06/2022 | Samsca | Tolvaptan | Otsuka | Hetero Labs |
| 09/06/2022 | Samsca | Tolvaptan | Otsuka | Apotex |
| 09/06/2022 | Revlimid | Lenalidomide | Celgene | Cipla |
| 09/06/2022 | Samsca | Tolvaptan | Otsuka | Alkem Labs |
| 09/06/2022 | Isuprel | Isoproterenol HCl | Bausch | Mylan |
| 09/06/2022 | Mutamycin | Mitomycin | Bristol Myers Squibb | Meitheal |
| 09/06/2022 | Onfi | Clobazam | Lundbeck | Accord Healthcare |
| 09/07/2022 | Gilenya | Fingolimod HCl | Novartis | Prinston |
| 09/07/2022 | Daliresp | Roflumilast | AstraZeneca | MSN |
| 09/07/2022 | Sabril | Vigabatrin | Lundbeck | MSN |
| 09/07/2022 | Timoptic | Timolol Maleate | Bausch | Micro Labs |
| 09/08/2022 | Lymphazurin | Isosulfan Blue | Mylan | Fresenius Kabi |
| 09/08/2022 | Mutamycin | Mitomycin | Bristol Myers Squibb | Meitheal |
| 09/08/2022 | Tambocor | Flecainide Acetate | Alvogen | Yichang Humanwell |
| 09/08/2022 | Dexamethasone | Dexamethasone | Hikma | Amneal |
| 09/09/2022 | Latuda | Lurasidone HCl | Sunovion | MSN |
| 09/09/2022 | Vraylar | Cariprazine HCl | AbbVie | Zydus |
| 09/12/2022 | Revlimid | Lenalidomide | Celgene | Zydus |
| 09/12/2022 | Carafate | Sucralfate | AbbVie | Mylan |
| 09/13/2022 | Prozac | Fluoxetine HCl | Eli Lilly | Piramal Healthcare |
| 09/13/2022 | Tazorac | Tazarotene | AbbVie | Cosette |
| 09/13/2022 | Zetia | Ezetimibe | Merck | Orient Pharma |
| 09/13/2022 | Timoptic in Ocudose | Timolol Maleate | Bausch | Ingenus Pharms |
| 09/14/2022 | Amicar | Aminocaproic Acid | Akorn | Optimus |
| 09/14/2022 | Lyrica CR | Pregabalin | Pfizer | ScieGen Pharms |
| 09/14/2022 | Vimpat IV | Lacosamide | UCB | Aspiro |
| 09/15/2022 | Geodon | Ziprasidone Mesylate | Viatris | MSN |
| 09/16/2022 | Dexilant | Dexlansoprazole | Takeda | TWi Pharms |
| 09/16/2022 | Lymphazurin | Isosulfan Blue | Covidien | MSN |
| 09/19/2022 | Byvalson | Nebivolol HCL / Valsartan | Allergan | Prinston |
| 09/19/2022 | Xylocaine | Lidocaine HCl | Fresenius Kabi | Sintetica Sa |
| 09/19/2022 | Cosopt | Dorzolamide HCl / Timolol Maleate | Thea Pharma | Gland Pharma |
| 09/19/2022 | Vimpat | Lacosamide | UCB | Gland Pharma |
| 09/20/2022 | Isuprel | Isoproterenol HCl | Bausch | Sti Pharma |
| 09/21/2022 | Pennsaid 2% | Diclofenac Sodium | Horizon | Lupin |
| 09/21/2022 | Esbriet | Pirfenidone | Genentech | Hetero Labs |
| 09/21/2022 | Sinemet | Carbidopa / Levodopa | Organon | Rubicon |
| 09/22/2022 | Timoptic XE | Timolol Maleate | Bausch | Dr Reddy's Labs |
| 09/22/2022 | Jadenu Sprinkle | Deferasirox | Novartis | Annora Pharma |
| 09/22/2022 | Bethkis | Tobramycin | Chiesi | Mankind |
| 09/23/2022 | Exjade | Deferasirox | Novartis | Teva |
| 09/23/2022 | Vimpat | Lacosamide | UCB | Apotex |
| 09/23/2022 | Voltaren XR | Diclofenac Sodium | Novartis | Riconpharma |
| 09/23/2022 | Cardizem | Diltiazem HCl | Bausch | ScieGen Pharms |
| 09/23/2022 | Pathocil | Dicloxacillin Sodium | Wyeth | Aurobindo |
| 09/26/2022 | Solu-Medrol | Methylprednisolone Sodium Succinate | Pfizer | Hikma |
| 09/26/2022 | Namenda | Memantine HCl | Allergan | Hetero Labs |
| 09/26/2022 | Vimpat | Lacosamide | UCB | Apotex |
| 09/26/2022 | Rexulti | Brexpiprazole | Otsuka | Sandoz |
| 09/26/2022 | Toprol XL | Metoprolol Succinate | AstraZeneca | Sunshine |
| 09/26/2022 | Lincocin | Lincomycin HCl | Pfizer | Gland Pharma |
| 09/26/2022 | Amicar | Aminocaproic Acid | Akorn | Aurobindo |
| 09/28/2022 | Myrbetriq | Mirabegron | Astellas | Lupin |
| 09/28/2022 | Mycamine | Micafungin Sodium | Astellas | Nanjing King-Friend |
| 09/29/2022 | Prezista | Darunavir | Johnson & Johnson | Lupin |
| 09/29/2022 | Pennsaid 2% | Diclofenac Sodium | Horizon | Taro |
| 09/29/2022 | Myrbetriq | Mirabegron | Astellas | Zydus |
| 09/29/2022 | Revatio | Sildenafil Citrate | Pfizer | Zydus |
| 09/29/2022 | Phenylephrine HCl | Phenylephrine HCl | Akorn | Mankind Pharma |
| 09/30/2022 | Vraylar | Cariprazine HCl | AbbVie | Sun Pharm |
