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 |
|---|---|---|---|---|
| 10/01/2020 | Diamox | Acetazolamide | Teva | Micro Labs |
| 10/01/2020 | Proamatine | Midodrine HCl | Takeda | Xiromed |
| 10/02/2020 | Nexium | Esomeprazole Magnesium | AstraZeneca | CSPC Ouyi |
| 10/02/2020 | Anafril | Clomipramine HCl | SpecGx | Ajanta Pharma |
| 10/06/2020 | Acticlate | Doxycycline Hyclate | Almirall | Mylan |
| 10/06/2020 | Tecfidera | Dimethyl Fumarate | Biogen | Lupin |
| 10/06/2020 | Tecfidera | Dimethyl Fumarate | Biogen | Glenmark |
| 10/06/2020 | Methylin ER | Methylphenidate HCl | SpecGx | Alkem Labs |
| 10/06/2020 | Monurol | Fosfomycin Tromethamine | Zambon | Xiromed |
| 10/06/2020 | Akovaz | Ephedrine Sulfate | Exela | Dr Reddy's Labs |
| 10/06/2020 | Firazyr | Icatibant Acetate | Shire | Dr Reddy's Labs |
| 10/06/2020 | Lomotil | Diphenoxylate HCl / Atropine Sulfate | Pfizer | Specgx |
| 10/06/2020 | Ultravate | Halobetasol Propionate | Sun Pharma | Quagen |
| 10/07/2020 | Sensipar | Cinacalcet HCl | Amgen | Hetero Labs |
| 10/07/2020 | Finacea | Azelaic Acid | Leo | Teva |
| 10/07/2020 | Diamox | Acetazolamide | Teva | Mankind |
| 10/08/2020 | Proventil | Albuterol Sulfate | Schering Plough | Eywa |
| 10/08/2020 | Phernagen with Codeine | Promethazine HCl / Codeine Phosphate | ANI Pharma | Quagen |
| 10/09/2020 | Nordette-28 | Levonorgestrel / Ethinyl Estradiol | Teva | Naari Pte |
| 10/09/2020 | Lioresal | Baclofen | Novartis | Innogenix |
| 10/13/2020 | Ultiva | Remifentanil HCl | Mylan | Navinta |
| 10/13/2020 | Kerydin | Tavaborole | Anacor | Encube |
| 10/13/2020 | Kerydin | Tavaborole | Anacor | Perrigo |
| 10/14/2020 | Gilenya | Fingolimod HCl | Novartis | Zydus |
| 10/14/2020 | Tecfidera | Dimethyl Fumarate | Biogen | Twi |
| 10/15/2020 | Isoptin | Verapamil HCl | Mt Adams Tech | Zydus |
| 10/15/2020 | Symmetrel | Amantadine HCl | Endo | Alembic Pharms |
| 10/15/2020 | Isoptin | Verapamil HCl | Mt Adams Tech | Gland Pharma |
| 10/16/2020 | Rapamune | Sirolimus | Pfizer | Glenmark Pharms |
| 10/16/2020 | Sinequan | Doxepin HCl | Pfizer | Epic Pharma |
| 10/16/2020 | Actigall | Ursodiol | Allergan | Zydus |
| 10/19/2020 | Vesicare | Solifenacin Succinate | Astellas | Zydus |
| 10/19/2020 | Levo T | Levothyroxine Sodium | Cediprof | Accord Healthcare |
| 10/19/2020 | Tricor (Micronized) | Fenofibrate (Micronized) | AbbVie | Alembic Pharms |
| 10/19/2020 | Advil | Ibuprofen | Glaxo | Yichang Humanwell |
| 10/20/2020 | Toradol | Ketorolac Tromethamine | Roche | Aurobindo Pharma |
| 10/20/2020 | Librax | Chlordiazepoxide HCl / Clidinium Bromide | Bausch & Lomb | ECI Pharms |
| 10/20/2020 | Halcion | Triazolam | Pharmacia/Upjohn | Riconpharma |
| 10/21/2020 | Lomotil | Diphenoxylate HCl / Atropine Sulfate | Pfizer | ECI Pharms |
| 10/21/2020 | Ofirmev | Acetaminophen | Mallinckrodt | Aurobindo Pharma |
| 10/21/2020 | Emend | Aprepitant | Merck | Torrent |
| 10/21/2020 | Kerydin | Tavaborole | Anacor | Aleor Dermaceuticals / Alembic |
| 10/21/2020 | Skelaxin | Metaxalone | Pfizer | Ingenus Pharms |
| 10/21/2020 | Venlafaxine HCl | Venlafaxine HCl | Osmotica | Ascent Pharms |
| 10/21/2020 | Klor-Con | Potassium Chloride | Upsher-Smith | Granules |
| 10/22/2020 | Lybrel | Dolishale Levonorgestrel / Ethinyl Estradiol | Wyeth | Novast Labs |
| 10/22/2020 | Uloric | Febuxostat | Takeda | Dr Reddys Labs |
| 10/22/2020 | Proventil | Albuterol Sulfate | Schering Plough | Zydus Pharms |
| 10/22/2020 | Zyprexa | Olanzapine | Eli Lilly | Aurobindo Pharma |
| 10/22/2020 | Timoptic XE | Timolol Maleate | Bausch & Lomb | Alembic Pharms |
| 10/22/2020 | BiCNU | Carmustine | Emcure | Dr Reddys Labs |
| 10/22/2020 | Wellcovorin | Leucovorin Calcium | Glaxo | Leading Pharma |
| 10/23/2020 | Zetia | Ezetimibe | Merck | Sciegen Pharms |
| 10/23/2020 | Cialis | Tadalafil | Eli Lilly | Umedica Labs |
| 10/23/2020 | Zyflo CR | Zileuton | Chiesi | Aizant |
| 10/23/2020 | Busulfex | Busulfan | Otsuka | Meitheal/Nanjing King-Friend |
| 10/23/2020 | Clolar | Clofarabine | Genzyme | Hong Kong |
| 10/26/2020 | Rozarem | Ramelteon | Takeda | Appco |
| 10/26/2020 | Thorazine | Chlorpromazine HCl | Upsher-Smith | Sun Pharm |
| 10/27/2020 | Magnesium Sulfate in Dextrose 5% in Plastic Container | Magnesium Sulfate in Dextrose 5% in Plastic Container | Hospira | B Braun Medical |
| 10/27/2020 | Cialis | Tadalafil | Eli Lilly | Yangling Buchang |
| 10/27/2020 | Nimbex Preservative Free | Cisatracurium Besylate Preservative Free | AbbVie | Aurobindo |
| 10/27/2020 | Dibenzyline | Phenoxybenzamine HCl | Concordia | Amneal |
| 10/27/2020 | Quelicin | Succinylcholine Chloride | Pfizer | Nexus Pharms |
| 10/27/2020 | Evekeo | Amphetamine Sulfate | Arbor | Alkem Labs |
| 10/27/2020 | Evekeo | Amphetamine Sulfate | Arbor | Epic Pharma |
| 10/27/2020 | Ditropan XL | Oxybutynin Chloride | Johnson & Johnson | Rubicon |
| 10/28/2020 | Gilenya | Fingolimod HCl | Novartis | Accord Healthcare |
| 10/28/2020 | Tirosint | Levothyroxine Sodium | IBSA | Teva |
| 10/28/2020 | Ritalin | Methylphenidate HCl | Novartis | Accord Healthcare |
| 10/29/2020 | Nitropress | Sodium Nitroprusside | Hospira | Xiromed |
| 10/29/2020 | Invega | Paliperidone | Janssen | CSPC Ouyi |
| 10/30/2020 | Singulair | Montelukast Sodium | Merck | Laboratorios Liomont |
| 10/30/2020 | Pomalyst | Pomalidomide | Celgene | Breckenridge |
| 10/30/2020 | Pomalyst | Pomalidomide | Celgene | Eugia Pharma/ Aurobindo |
| 10/30/2020 | Edecrin | Ethacrynic Acid | Bausch & Lomb | Strides |
| 10/30/2020 | Claritin Reditabs | Loratadine | Bayer | Tenshi |
| 11/02/2020 | Methadose | Methadone HCl | SpecGx | Lannett |
| 11/02/2020 | Vidaza | Azacitidine | Celgene | Meitheal |
| 11/02/2020 | Parafone Forte | Chlorzoxazone | Mikart | Par |
| 11/02/2020 | Camptosar | Irinotecan HCl | Pfizer | Eugia Pharma |
| 11/03/2020 | Bystolic | Nebivolol HCl | Allergan | Hetero Labs |
| 11/03/2020 | Levophed | Norepinephrine Bitartrate | Hospira | Fresenius Kabi |
| 11/05/2020 | Bromfed DM | Brompheniramine Maleate / Pseudoephedrine HCl / Dextromethorphan Hydrobromide | Wockhardt | Rhodes Pharms |
| 11/05/2020 | Mycamine | Micafungin Sodium | Astellas | Apotex |
| 11/05/2020 | Fetzima | Levomilnacipran HCl | Allergan | Hikma |
| 11/06/2020 | Nimbex Preservative Free | Cisatracurium Besylate | AbbVie | Sagent Pharms |
| 11/06/2020 | Nimbex | Cisatracurium Besylate | AbbVie | Sagent Pharms |
| 11/06/2020 | Toprol-XL | Metoprolol Succinate | Aralez | Hetero Labs |
| 11/06/2020 | Amicar | Aminocaproic Acid | Akorn | MSN |
| 11/09/2020 | Tarceva | Erlotinib HCl | Genentech | Teva |
| 11/09/2020 | Zovirax | Acyclovir | Bausch & Lomb | Amneal |
| 11/09/2020 | Taytulla | Norethindrone Acetate / Ethinyl Estradiol | Allergan | Chemo Research |
| 11/10/2020 | Prograf | Tacrolimus | Astellas | Glenmark |
| 11/10/2020 | Prograf | Tacrolimus | Astellas | Biocon Pharma |
| 11/10/2020 | Prograf | Tacrolimus | Astellas | Concord Biotech/Lupin |
| 11/10/2020 | Kenalog | Triamcinolone Acetonide | CMP Pharma | Cintex Svcs |
| 11/10/2020 | Cleocin T | Clindamycin Phosphate | Pfizer | Taro Pharms |
| 11/12/2020 | Prograf | Tacrolimus | Astellas | Alkem Labs |
| 11/12/2020 | Nexavar | Sorafenib Tosylate | Bayer | Teva |
| 11/12/2020 | Questran Light | Cholestyramine Light | Bristol-Myers Squibb | Tagi |
| 11/12/2020 | Astepro | Azelastine HCl | Mylan | Aurobindo |
| 11/13/2020 | Vazculep | Phenylephrine HCl | Exela | Aurobindo |
| 11/13/2020 | Cosmogen | Dactinomycin | Recordati Rare Diseases | Hong Kong |
| 11/13/2020 | Sabril | Vigabatrin | Lundbeck | Accord Healthcare |
| 11/17/2020 | Depakote | Divalproex Sodium | AbbVie | Teva |
| 11/17/2020 | Faslodex | Fulvestrant | AstraZeneca | Accord Healthcare |
| 11/18/2020 | Procardia XL | Nifedipine | Pfizer | Elite |
| 11/18/2020 | Nexium | Esomeprazole Magnesium | AstraZeneca | Amta |
| 11/20/2020 | Deltasone | Prednisone | Pharmacia/Upjohn | Strides |
| 11/20/2020 | Renvela | Sevelamer Carbonate | Genzyme | Impax/Amneal |
| 11/20/2020 | Quelicin | Succinylcholine Chloride | Pfizer | Fresenius Kabi |
| 11/23/2020 | Dacogen | Decitabine | Otsuka | Apotex |
| 11/23/2020 | Precedex | Dexmedetomidine HCl | Hospira | Tagi |
| 11/23/2020 | Cialis | Tadalafil | Eli Lilly | Sunshine |
| 11/24/2020 | Lodine XL | Etodolac | Wyeth | Bayshore Pharms |
| 11/24/2020 | Transderm SCOP | Scopolamine | Glaxo | Riconpharma |
| 11/24/2020 | Quelicin | Succinylcholine Chloride | Pfizer | Micro Labs |
| 11/25/2020 | Viagra | Sildenafil Citrate | Upjohn | Watson |
| 11/25/2020 | Axiron | Testosterone | Eli Lilly | Apotex |
| 11/25/2020 | Toprol-XL | Metoprolol Succinate | Aralez | Alkem Labs |
| 11/25/2020 | Kerydin | Tavaborole | Anacor | Amneal |
| 11/25/2020 | Tenoretic | Atenolol / Chlorthalidone | Almatica | Unichem |
| 11/25/2020 | Intuniv | Guanfacine HCl | Takeda | Yichang Humanwell |
| 11/27/2020 | Kepra XR | Levetiracetam | UCB | Sciegen Pharms |
| 11/27/2020 | Azopt | Brinzolamide | Novartis | Watson |
| 11/27/2020 | Hiprex | Methenamine Hippurate | Validus | Riconpharma |
| 11/27/2020 | Alinia | Nitazoxanide | Romark | Rising |
| 11/27/2020 | Hygroton | Chlorthalidone | Sanofi Aventis | Ajanta Pharma |
| 11/30/2020 | Wellbutrin XL | Bupropion HCl | Valeant | Sun Pharm |
| 11/30/2020 | Ranexa | Ranolazine | Gilead | Alkem Labs |
| 11/30/2020 | Depen | Penicillamine | Mylan | Lupin |
| 12/1/2020 | Lidoderm | Lidocaine | Teikoku | Noven Pharms |
| 12/2/2020 | Cuprimine | Penicillamine | Valeant | Granules |
| 12/2/2020 | Diulo | Metolazone | GD Searle | Alembic Pharms |
| 12/2/2020 | Sabril | Vigabatrin | Lundbeck | Alkem Labs |
| 12/3/2020 | Celebrex | Celecoxib | GD Searle | Sciegen Pharms |
| 12/3/2020 | Acular | Ketorolac Tromethamine | Allergan | Aurobindo |
| 12/3/2020 | Norvir | Ritonavir | AbbVie | Hikma |
| 12/3/2020 | Morphine Sulfate | Morphine Sulfate | Hikma | Alkem Labs |
| 12/4/2020 | Xeloda | Capecitabine | Hoffman La Roche | Dr Reddys Labs |
| 12/4/2020 | Welchol | Colesevelam HCl | Daiichi Sankyo | Inventia |
| 12/4/2020 | Xenazine | Tetrabenazine | Bausch & Lomb | Ajanta Pharma |
| 12/7/2020 | Precedex | Dexmedetomidine HCl | Pfizer | Aurobindo |
| 12/7/2020 | Dacogen | Decitabine | Otsuka | Nivagen Pharms |
| 12/8/2020 | Emend IV | Fosaprepitant Dimeglumine | Merck | Sandoz |
| 12/8/2020 | Rubramin PC | Cyanocobalamin | Bristol-Myers Squibb | Aurobindo |
| 12/9/2020 | Afinitor | Everolimus | Novartis | Par Pharm |
| 12/9/2020 | Emend IV | Fosaprepitant Dimeglumine | Merck | Dr Reddys Ltd |
| 12/9/2020 | Onfi | Clobazam | Lundbeck | Celltrion |
| 12/9/2020 | Celebrex | Celecoxib | GD Searle | Acic Pharms |
| 12/10/2020 | Saphris | Asenapine Maleate | AbbVie | Breckenridge |
| 12/10/2020 | Saphris | Asenapine Maleate | AbbVie | Alembic Pharms |
| 12/10/2020 | Saphris | Asenapine Maleate | AbbVie | Sigmapharm Labs |
| 12/10/2020 | Acticlate | Doxycycline Hyclate | Almirall | Nostrum Labs |
| 12/10/2020 | Nitropress | Sodium Nitroprusside | Hospira | Aurobindo Pharma |
| 12/10/2020 | Prilosec | Omeprazole | P&G | Xiromed |
| 12/11/2020 | Namenda | Memantine HCl | Allergan | Polygen Pharms |
| 12/11/2020 | Gemcitabine HCl | Gemcitabine HCl | Hospira | Nanjing King-Friend |
| 12/11/2020 | Versed | Midazolam HCl | Hoffman La Roche | Hikma |
| 12/14/2020 | Immodium Multi-Symptom Relief | Loperamide Hydrochloride / Simethicone | Johnson & Johnson | Aurobindo Pharma |
| 12/14/2020 | Amicar | Aminocaproic Acid | Akorn | ANI Pharms |
| 12/15/2020 | Renagel | Sevelamer HCl | Genzyme | Mylan |
| 12/15/2020 | Akovaz | Ephedrine Sulfate | Exela | Hikma |
| 12/16/2020 | Methylin | Methylphenidate HCl | SpecGx | Lannett |
| 12/16/2020 | Lodine | Etodolac | Wyeth | Bayshore Pharms |
| 12/16/2020 | Jublia | Efinaconazole | Bausch & Lomb | Teva |
| 12/16/2020 | Jublia | Efinaconazole | Bausch & Lomb | Perrigo |
| 12/16/2020 | Firazyr | Icatibant Acetate | Shire | Nang Kuang Pharm |
| 12/16/2020 | Acticlate | Doxycycline Hyclate | Almirall | Epic Pharma |
| 12/17/2020 | Vytorin | Ezetimibe / Simvastatin | Merck | Mylan |
| 12/17/2020 | Welchol | Colesevelam HCl | Daiichi Sankyo | Lupin |
| 12/17/2020 | Advair Diskus | Fluticasone Propionate / Salmeterol Xinafoate | Glaxo | Hikma |
| 12/17/2020 | Ditropan | Oxybutynin Chloride | Janssen | Strides Pharma |
| 12/18/2020 | Gilenya | Fingolimod HCl | Novartis | Apotex |
| 12/18/2020 | Lasix | Furosemide | Sanofi Aventis | Areva Pharms |
| 12/18/2020 | Taytulla | Norethindrone Acetate / Ethinyl Estradiol | Allergan | Slayback Pharma |
| 12/18/2020 | Banzel | Rufinamide | Eisai | Lupin |
| 12/18/2020 | Apresoline | Hydralazine HCl | Novartis | Hikma |
| 12/18/2020 | Amidate | Etomidate | Pfizer | Caplin |
| 12/21/2020 | Quelicin | Succinylcholine Chloride | Pfizer | Deva Holding |
| 12/23/2020 | Trilipix | Fenofibric Acid | AbbVie | Yichang Humanwell |
| 12/28/2020 | Glucagon | Glucagon | Eli Lilly | Amphastar Pharms |
| 12/28/2020 | Latuda | Lurasidone HCl | Sunovion | Piramal Healthcare |
| 12/29/2020 | Cialis | Tadalafil | Eli Lilly | Glenmark |
| 12/29/2020 | Potassium Chloride | Potassium Chloride | Merck | Ascent Pharms |
| 12/29/2020 | Liquaemin Sodium | Heparin Sodium | Organon | Be Pharms |
| 12/29/2020 | Liquaemin Sodium | Heparin Sodium | Organon | Be Pharms |
| 12/30/2020 | Levaquin in Dextrose 5% in Plastic Container | Levofloxacin in Dextrose 5% in Plastic Container | Janssen | Gland Pharma |
| 12/30/2020 | Gilenya | Fingolimod HCl | Novartis | Alkem Labs |
| 12/31/2020 | Wellbutrin XL | Bupropion HCl | Valeant | Sun Pharm |
| 12/31/2020 | Zyprexa | Olanzapine | Eli Lilly | Pharmtak |
| 12/31/2020 | Zyprexa | Olanzapine | Eli Lilly | Pharmtak |
| 12/31/2020 | Cleocin T | Clindamycin Phosphate | Pfizer | Gage Development |
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