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.
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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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