ANDA Approvals - Summer 2021

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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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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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