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 |
4/1/2021 |
Tobi |
Tobramycin |
Mylan |
Alkem |
4/1/2021 |
Sinequan |
Doxepin HCl |
Pfizer |
Appco |
4/2/2021 |
Truvada |
Emtricitabine / Tenofovir Disoproxil Fumarate |
Gilead |
Cipla |
4/2/2021 |
Namenda XR |
Memantine HCl |
AbbVie |
Yichang Humanwell |
4/2/2021 |
Kybella |
Deoxycholic Acid |
Kythera |
Slayback |
4/2/2021 |
Dermotic / Derma-Smooth FS |
Fluocinolone Acetonide |
Hill |
Solaris Pharma |
4/5/2021 |
Bloxiverz |
Neostigmine Methylsulfate |
Exela |
Meitheal |
4/6/2021 |
Opsumit |
Macitentan |
Actellion |
Zydus |
4/7/2021 |
Viibryd |
Vilazodone HCl |
AbbVie |
Invagen Pharms |
4/8/2021 |
Aggrastat |
Tirofiban HCl |
Medicure |
Gland Pharma |
4/8/2021 |
Cardene |
Nicardipine HCl |
Chiesi |
Aurobindo |
4/8/2021 |
Amicar |
Aminocaproic Acid |
Akorn |
Airis Pharma |
4/12/2021 |
Dacogen |
Decitabine |
Otsuka |
Qilu |
4/12/2021 |
Absorica |
Isotretinoin |
Sun |
Upsher Smith Labs |
4/13/2021 |
Lyrica CR |
Pregabalin |
Pfizer |
Alvogen Pine Brook |
4/13/2021 |
Lyrica CR |
Pregabalin |
Pfizer |
Sun Pharm |
4/13/2021 |
Lyrica CR |
Pregabalin |
Pfizer |
Mylan |
4/13/2021 |
Lyrica CR |
Pregabalin |
Pfizer |
MSN |
4/13/2021 |
Lyrica CR |
Pregabalin |
Pfizer |
Apotex |
4/13/2021 |
Tegretol XR |
Carbamazepine |
Novartis |
CSPC Ouyi |
4/14/2021 |
Pulmicort Respules |
Budesonide |
Sun |
Sun Pharm |
4/14/2021 |
Miralax |
Polyethylene Glycol 3350 |
Bayer |
Annora Pharma |
4/15/2021 |
Acetadote |
Acetylcysteine |
Exela |
Exela Pharma |
4/16/2021 |
Glumetza |
Metformin HCl |
Bausch & Lomb |
Sciegen Pharms |
4/16/2021 |
Primacor |
Milrinone Lactate |
Sanofi Aventis |
Caplin |
4/20/2021 |
Solu Medrol |
Methylprednisolone Sodium Succinate |
Pfizer |
Tianjin Kingyork |
4/20/2021 |
Xylocaine |
Lidocaine |
AstraZeneca |
Quagen |
4/20/2021 |
Bloxiverz |
Neostigmine Methylsulfate |
Exela |
Caplin |
4/20/2021 |
Pepcid |
Famotidine |
Salix |
Novitium Pharma |
4/21/2021 |
Xyzal |
Levocetirizine HCl |
Sanofi Aventis |
Apotex |
4/21/2021 |
Cubicin |
Daptomycin |
Cubist |
Hisun Pharm Hangzhou |
4/21/2021 |
Foscavir |
Foscarnet Sodium |
Pfizer |
Gland Pharma |
4/21/2021 |
Rythmol SR |
Propafenone HCl |
GlaxoSmithKline |
Zydus |
4/21/2021 |
Sinequan |
Doxepin HCl |
Pfizer |
Alembic Pharms |
4/22/2021 |
Adderall |
Dextroamp Saccharate / Amp Aspartate / Dextroamp Sulfate / Amp Sulfate |
Teva |
Ascent Pharms |
4/22/2021 |
Compazine |
Prochlorperazine Edisylate |
GlaxoSmithKline |
Caplin |
4/23/2021 |
Rheumatrex |
Methotrexate Sodium |
Endo |
Lotus Pharm |
4/23/2021 |
Bentyl |
Dicyclomine HCl |
Adare |
Novitium Pharma |
4/26/2021 |
Magnesium Sulfate |
Magnesium Sulfate |
Hospira |
B Braun Medical |
4/26/2021 |
Lescol XL |
Fluvastatin Sodium |
Novartis |
Beijing |
4/26/2021 |
Librax |
Chlordiazepoxide HCl / Clidinium Bromide |
Bausch & Lomb |
Alkem Labs |
4/26/2021 |
Thiola |
Tiopronin |
Mission Pharma |
Teva |
4/27/2021 |
Viibryd |
Vilazodone HCl |
AbbVie |
Accord Healthcare |
4/28/2021 |
Duac |
Clindamycin Phosphate / Benzoyl Peroxide |
Glaxo |
Encube |
4/28/2021 |
Northera |
Droxidopa |
Lundbeck |
Bionpharma |
4/29/2021 |
Lidoderm |
Lidocaine |
Teikoku Pharma |
Nal Pharm |
4/29/2021 |
Revatio |
Sildenafil Citrate |
Pfizer |
Appco |
4/30/2021 |
Reyataz |
Atazanavir Sulfate |
Bristol-Myers Squibb |
Laurus Labs |
4/30/2021 |
Robaxin |
Methocarbamol |
Auxilium |
MLV |
4/30/2021 |
Sanctura XR |
Trospium Chloride |
Allergan |
AMTA |
5/3/2021 |
Nitrostat |
Nitroglycerin |
Pfizer |
Rubicon |
5/3/2021 |
Butrans |
Buprenorphine |
Purdue |
Mylan |
5/3/2021 |
Zoloft |
Sertraline HCl |
Upjohn |
Ascent Pharms |
5/4/2021 |
Focalin XR |
Dexmethylphenidate HCl |
Novartis |
Mylan |
5/4/2021 |
Cosopt |
Dorzolamide HCl / Timolol Maleate |
Akorn |
Alembic Pharms |
5/5/2021 |
Northera |
Droxidopa |
Lundbeck |
Tris Pharma |
5/6/2021 |
Onfi |
Clobazam |
Lundbeck |
Alkem Labs |
5/6/2021 |
Levophed |
Norepinephrine Bitartrate |
Hospira |
Gland Pharma |
5/7/2021 |
Claritin |
Loratadine |
Bayer |
Hetero Labs |
5/7/2021 |
Kerydin |
Tavaborole |
Anacor |
Taro Pharms |
5/7/2021 |
Sinemet |
Carbidopa / Levodopa |
Merck Sharp and Dohme |
Sciegen Pharms |
5/10/2021 |
Arava |
Leflunomide |
Sanofi Aventis |
Aet Pharma |
5/10/2021 |
Tarceva |
Erlotinib HCl |
Roche |
MSN |
5/10/2021 |
Librax |
Chlordiazepoxide HCl / Clidinium Bromide |
Bausch & Lomb |
Dr Reddy's |
5/10/2021 |
Neurontin |
Gabapentin |
Upjohn |
Ascent Pharms |
5/11/2021 |
Banzel |
Rufinamide |
Eisai |
Hetero Labs |
5/11/2021 |
Revatio |
Sildenafil Citrate |
Upjohn |
Hetero Labs |
5/11/2021 |
Onfi |
Clobazam |
Lundbeck |
MSN |
5/13/2021 |
Latuda |
Lurasidone HCl |
Sunovion |
Alembic Pharms |
5/13/2021 |
Tygacil |
Tigecycline |
PF Prism |
Hong Kong |
5/13/2021 |
Sabril |
Vigabatrin |
Lundbeck |
Dexcel Pharma |
5/14/2021 |
Cosopt |
Dorzolamide HCl / Timolol Maleate |
Akorn |
Aurobindo |
5/14/2021 |
Xtandi |
Enzalutamide |
Astellas |
Actavis |
5/14/2021 |
Miacalcin |
Calcitonin-Salmon |
Mylan |
Custopharm |
5/14/2021 |
Jadenu |
Deferasirox |
Novartis |
Annora Pharma |
5/17/2021 |
Renvela |
Sevelamer Carbonate |
Genzyme |
Bionpharma |
5/18/2021 |
Nebcin |
Tobramycin Sulfate |
Eli Lilly |
Gland Pharma |
5/18/2021 |
Ranexa |
Ranolazine |
Gilead |
Accord Healthcare |
5/19/2021 |
Isuprel |
Isoproterenol HCl |
Bausch & Lomb |
Amring Pharms |
5/19/2021 |
Zovirax |
Acyclovir |
Bausch & Lomb |
Macleods |
5/19/2021 |
Amitid |
Amitriptyline HCl |
BMS |
Unichem |
5/20/2021 |
Zortress |
Everolimus |
Novartis |
Breckenridge |
5/20/2021 |
Ketozole |
Ketoconazole |
Taro |
Encube |
5/21/2021 |
Revlimid |
Lenalidomide |
Celgene |
Natco Pharma |
5/21/2021 |
Augmentin |
Amoxicillin / Clavulanate Potassium |
US Antibiotics |
Micro Labs |
5/21/2021 |
Zinc Chloride |
Zinc Chloride |
Hospira |
Exela Pharma |
5/21/2021 |
Firazyr |
Icatibant Acetate |
Shire |
Glenmark |
5/21/2021 |
Extina |
Ketoconazole |
Mylan |
Xiromed |
5/27/2021 |
Jadenu |
Deferasirox |
Novartis |
Celltrion |
5/27/2021 |
Imodium |
Loperamide HCl / Simethicone |
Johnson & Johnson |
Guardian Drug |
5/27/2021 |
Permitil |
Fluphenazine HCl |
Schering |
Zydus |
5/28/2021 |
Vicoprin |
Hydrocodone Bitartrate / Aspirin |
Abbott |
LGM Pharma |
5/28/2021 |
Alkeran |
Melphalan HCl |
Apotex |
Hong Kong |
5/28/2021 |
Angiomax |
Bivalirudin |
Sandoz |
Hainan Poly Pharm |
6/1/2021 |
Proventil HFA |
Albuterol Sulfate |
Kindeva |
Sandoz |
6/1/2021 |
Xeljanz |
Tofacitinib Citrate |
PF Prism |
Ajanta Pharma |
6/2/2021 |
Mycamine |
Micafungin Sodium |
Astellas |
Xellia Pharms |
6/2/2021 |
Oxycodone HCl |
Oxycodone HCl |
Genus |
Quagen |
6/2/2021 |
Thorazine |
Chlorpromazine HCl |
Glaxo |
Genus |
6/3/2021 |
Theophylline |
Theophylline |
Alembic |
Glenmark |
6/4/2021 |
Kaletra |
Lopinavir / Ritonavir |
AbbVie |
Hetero Labs |
6/4/2021 |
Truvada |
Emtricitabine / Tenofovir Disoproxil Fumarate |
Gilead |
Lupin |
6/7/2021 |
Zenzendi |
Dextroamphetamine Sulfate |
Arbor |
Winder Labs |
6/10/2021 |
Effexor XR |
Venlafaxine HCl |
Osmotica |
Alkem Labs |
6/11/2021 |
Kyprolis |
Carfilzomib |
Amgen |
Breckenridge |
6/11/2021 |
Faslodex |
Fulvestrant |
AstraZeneca |
Apotex |
6/11/2021 |
Mirapex ER |
Pramipexole Dihydrochloride |
Boehringer-Ingelheim |
Xiamen LP Pharm |
6/11/2021 |
Keppra |
Levetiracetam |
UCB |
Sciegen Pharms |
6/14/2021 |
Amicar |
Aminocaproic Acid |
Akorn |
Edenbridge Pharms |
6/14/2021 |
Axiron |
Testosterone |
Eli Lilly |
Aleor Dermaceuticals |
6/14/2021 |
Intelence |
Etravirine |
Johnson & Johnson |
Amneal |
6/14/2021 |
Akovaz |
Ephedrine Sulfate |
Exela |
Aurobindo |
6/14/2021 |
Clobex |
Clobetasol Propionate |
Galderma |
Amneal |
6/15/2021 |
Kuvan |
Sapropterin Dihydrochloride |
Biomarin |
Dr Reddy's |
6/15/2021 |
Suboxone |
Buprenorphine HCl / Naloxone HCl |
Indivior |
Alkem |
6/16/2021 |
Sustiva |
Efavirenz |
Bristol-Myers Squibb |
Strides |
6/16/2021 |
Boniva |
Ibandronate Sodium |
Roche |
Nang Kuang |
6/16/2021 |
Truvada |
Emtricitabine / Tenofovir Disoproxil Fumarate |
Gilead |
Apotex |
6/16/2021 |
Renagel |
Sevelamer HCl |
Genzyme |
Lupin |
6/17/2021 |
Imodium |
Loperamide HCl / Simethicone |
Johnson & Johnson |
Hetero Labs |
6/17/2021 |
Levo-Dromoran |
Levorphanol Tartrate |
Valeant |
Sun Pharm |
6/21/2021 |
Jublia |
Efinaconazole |
Bausch & Lomb |
Acrux DDS |
6/21/2021 |
Trileptal |
Oxcarbazepine |
Novartis |
Glasshouse Pharms |
6/22/2021 |
Perforomist |
Formoterol Fumarate |
Mylan |
Teva |
6/22/2021 |
Brovana |
Arformoterol Tartrate |
Sunovion |
Cipla |
6/22/2021 |
Brovana |
Arformoterol Tartrate |
Sunovion |
Glenmark |
6/22/2021 |
Brovana |
Arformoterol Tartrate |
Sunovion |
Axar Pharms |
6/25/2021 |
Gemzar |
Gemcitabine HCl |
Eli Lilly |
Hikma |
6/25/2021 |
Macrodantin |
Nitrofurantoin |
Almatica |
Alembic |
6/25/2021 |
Taxotere |
Docetaxel |
Sanofi Aventis |
Eugia Pharma |
6/28/2021 |
Cleocin T |
Clindamycin Phosphate |
Pfizer |
Taro Pharms |
6/29/2021 |
Aloxi |
Palonosetron HCl |
Eli Lilly |
Emcure |
6/29/2021 |
Aptiom |
Eslicarbazepine Acetate |
Sunovion |
Dr Reddys |
6/29/2021 |
Cubicin |
Daptomycin |
Cubist |
Hong Kong |
6/29/2021 |
Cubicin |
Daptomycin |
Sagent |
Hong Kong |
6/30/2021 |
Vascepa |
Icosapent Ethyl |
Amarin |
Apotex |
6/30/2021 |
Otezla |
Apremilast |
Amgen |
Amneal |
6/30/2021 |
Effexor XR |
Venlafaxine HCl |
Wyeth |
Appco |
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