ANDA Approvals

New Drug Applications and 505(b)(2) Applications

Second Quarter

GENERICally Speaking

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
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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