ANDA Approvals

Fall 2018

Robins Kaplan GENERICally Speaking: A Hatch-Waxman Litigation Bulletin
Approval Date Reference Listed Drug Generic Drug Name NDA Holder ANDA Applicant
7/2/2018 Emtriva Emtricitabine Gilead Cipla
7/2/2018 Cancidas Caspofungin Acetate Merck Xellia Pharms
7/2/2018 Rythmol SR Propafenone HCl GlaxoSmithKline Wilshire Pharms
7/2/2018 Vidaza Azacitidine Celgene Accord Healthcare
7/2/2018 Singulair Montelukast Sodium Merck Sharp Dohme Unichem Labs
7/2/2018 Xeloda Capecitabine Hoffmann La Roche MSN Labs
7/2/2018 Nicorette Nicotine Polacrilex GlaxoSmithKline Watson
7/2/2018 Docetaxel Docetaxel Hospira Mylan
7/2/2018 Bentyl Dicyclomine HCl Allergan APC Pharms
7/3/2018 Plan B One-Step Levonorgestrel FDN Consumer Haupt Pharma
7/3/2018 Uceris Budesonide Valeant Actavis Labs FL
7/3/2018 Zyprexa Zydis Olanzapine Eli Lilly HEC Pharm
7/3/2018 Haldol Haloperidol Decanoate Janssen Pharms Somerset Theraps
7/5/2018 Temodar Temozolomide Merck Sharp Dohme Apotex
7/5/2018 Zithromax Azithromycin Pfizer Aurobindo
7/5/2018 Zithromax Azithromycin Pfizer Aurobindo
7/5/2018 Vazculep Phenylephrine HCl West Ward Pharm / Avadel Legacy Amneal
7/6/2018 Hepsera Adefovir Dipivoxil Gilead Apotex
7/6/2018 Adrenalin Epinephrine Par Sterile Products Luitpold
7/6/2018 Plaquenil Hydroxychloroquine Sulfate Concordia Pharms Lupin
7/6/2018 Docetaxel Docetaxel Hospira Mylan Labs
7/9/2018 Macrodantin Nitrofurantoin Alvogen Novel Labs
7/9/2018 Tobi Tobramycin Novartis Dr Reddys
7/9/2018 Xanax Alprazolam Pharmacia and Upjohn Centaur Pharms PVT
7/10/2018 Bloxiverz Neostigmine Methylsulfate Avadel Legacy Dr Reddys
7/11/2018 Namenda Memantine HCl Allergan Apotex
7/11/2018 Zomig Zolmitriptan IPR Zydus
7/11/2018 Ampyra Dalfampridine Acorda Accord Healthcare
7/11/2018 D.H.E. 45 Dihydroergotamine Mesylate Valeant Sagent
7/11/2018 Mucinex Guaifenesin Reckitt Benckiser Amneal
7/12/2018 Cancidas Caspofungin Acetate Merck Cipla
7/13/2018 Oxytocin Oxytocin Fresenius Kabi USA & West-Ward Pharms / Par Sterile Products Sagent
7/13/2018 Busulfex Busulfan Otsuka Pharm Mylan
7/13/2018 Gleevec Imatinib Mesylate Novartis West-Ward Pharms
7/13/2018 Elocon Mometasone Furoate Merck Sharp Dohme Torrent
7/16/2018 Angiomax Bivalirudin The Medicines Co Sagent
7/16/2018 Welchol Colesevelam Hydrochloride Daiichi Sankyo Glenmark
7/16/2018 Glucotorol XL Glipizide Pfizer Zydus
7/16/2018 Infumorph / Morphine Sulfate Mitigo West-Ward Pharms / Hospira Piramal Critical
7/16/2018 Cleocin T Clindamycin Phosphate Pharmacia and Upjohn Zydus
7/16/2018 Vfend Voriconazole PF Prism Zydus
7/16/2018 Mucinex Guaifenesin (OTC) Reckitt Benckiser OHM Labs
7/16/2018 Dextrose 10% in Plastic Container Dextrose 10% in Plastic Container B Braun / Baxter Healthcare / ICU Medical Fresenius Kabi USA
7/16/2018 Minastrin 24 FE Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate Apil Chemo Research SL
7/17/2018 Zyprexa Olanzapine Lilly Zydus
7/17/2018 Feldene Piroxicam Pfizer Zydus
7/17/2018 Saphris Asenapine Maleate Forest Labs SigmaPharm Labs
7/17/2018 Lidex Fluocinonide County Line Pharms Zydus
7/18/2018 Aldactone Spironolactone GD Searle Zydus
7/19/2018 Zithromax Azithromycin Pfizer Amneal
7/19/2018 Potassium Chloride Potassium Chloride Genus LifeSciences Amneal
7/19/2018 Vazculep Phenylephrine HCl Avadel Legacy Amneal
7/20/2018 Treximet Sumatriptan / Naproxen Sodium Pernix Sun Pharma
7/20/2018 Integrilin Eptifibatide Schering Mylan
7/20/2018 Acetadote Acethylcysteine Cumberland Pharms Zydus
7/20/2018 Gemcitabine HCl Gemcitabine HCl Hospira Sagent
7/20/2018 Cetirizine HCl Cetirizine HCl Bionpharma Aurobindo
7/20/2018 Mestinon Pyridostigmine Bromide Valeant Invatech Pharma
7/23/2018 Sodium Chloride 0.45% in Plastic Container Sodium Chloride 0.45% in Plastic Container B Braun / ICU Medical Fresenius Kabi USA
7/23/2018 Corgard Nadolol US WorldMeds Beximco Pharms 
7/24/2018 Edecrin Ethacrynic Acid Aton Alvogen
7/24/2018 Amrix Cyclobenzaprine HCl Teva Apotex
7/24/2018 Cosopt / Cosopt PF Dorzolamide HCl / Timolol Maleate Oak Pharms Aurobindo
7/25/2018 Indium in 111 Oxyquinoline Indium in 111 Oxyquinoline GE Healthcare Nordion
7/25/2018 Intuniv Guanfacine HCl Shire Apotex
7/25/2018 Targretin Bexarotene Valeant Upsher-Smith Labs
7/27/2018 Azilect Rasagiline Mesylate Teva Sandoz
7/27/2018 Aricept ODT Donepezil HCl Eisai Hisun Pharm Hangzhou
7/27/2018 Angiomax Bivalirudin The Medicines Co Aurobindo
7/27/2018 Aubagio Teriflunomide Sanofi Aventis Watson
7/27/2018 Solaraze Diclofenac Sodium Fougera Pharms Gage Development
7/30/2018 Torisel Temsirolimus PF Prism Accord Healthcare
7/30/2018 Ampyra Dalfampridine Acorda Alkem Labs
7/31/2018 Busulfex Busulfan Otsuka Hospira
7/31/2018 Viread Tenofovir Disoproxil Fumarate Gilead Sciences Apotex
7/31/2018 Singulair Montelukast Sodium Merck Torrent
7/31/2018 Zithromax Azithromycin Pfizer Zydus
8/15/2018 Minivelle / Climara Estradiol Noven / Bayer Mylan
8/16/2018 EpiPen Epinephrine (Autoinjector) Mylan Teva
8/17/2018 Taxol Paclitaxel HQ Spclt Pharma Accord Healthcare
8/17/2018  Motrin Ibuprofen  J and J Consumer Guardian Drug
8/17/2018 Locoid Hydrocortisone Butyrate Precision Dermat Lupin
8/20/2018 Zantac 150 Ranitidine HCl Sanofi Granules India
8/21/2018 Motrin IB Ibuprofen J and J Consumer Aiping Pharm
8/21/2018 Precedex Dexmedetomidine HCl Hospira Baxter
8/21/2018 Aggrenox Aspirin / Dipyridamole Boehringer Ingelheim Sun Pharma
8/21/2018 Fluocinonide Fluocinonide Taro Amneal
8/10/2018 Zosyn Piperacillin / Tazobactam Wyeth Qilu Tianhe
8/13/2018 Gleevec Imatinib Mesylate Novartis Dr Reddys Labs
8/13/2018 Allegra Fexofenadine HCl Sanofi Aventis Unique Pharm Labs
8/22/2018 Truvada Emtricitabine / Tenofovir Disoproxil Fumarate Gilead Amneal
8/22/2018 Bloxiverz Neostigmine Methylsulfate Avadel Legacy Renaissance SSA
8/24/2018 Neurontin Gabapentin Pfizer Lupin
8/24/2018 Sporanox Itraconazole Janssen Torrent
8/24/2018 Docetaxel Docetaxel  Hospira Cipla
8/27/2018 Glucophage Metformin HCl Bristol-Myers Squibb Laurus Labs
8/28/2018 Lopid Gemfibrozil Pfizer Zydus
8/28/2018 Tricor Fenofibrate AbbVie Prinston
8/29/2018 Combivir Lamivudine / Zidovudine ViiV Healthcare MacLeods
8/29/2018 Potassium Chloride Potassium Chloride Genus LifeSciences Novel Labs
8/30/2018 Cardizem CD Diltiazem HCl Valeant TWi Pharms
8/30/2018 Sustiva Efavirenz Bristol-Myers Squibb Aurobindo
8/30/2018 Azor Amlodipine / Olmesartan Medoxomil Daiichi Sankyo Accord Healthcare
8/31/2018 Lomotil Diphenoxylate HCl / Atropine Sulfate GD Searle Upsher-Smith Labs
8/31/2018 Klor-Con Potassium Chloride Upsher-Smith Labs Strides
9/4/2018 Treximet Sumatriptan / Naproxen Sodium Pernix Mylan
9/4/2018 Atripla Efavirenz / Emtricitabine / Tenofovir Disoproxil Fumarate Gilead Sciences Aurobindo
9/4/2018 Brilinta Ticagrelor AstraZeneca Watson
9/4/2018 Aubagio Teriflunomide Sanofi Aventis Teva
9/4/2018 Targretin Bexarotene Valeant Amneal
9/5/2018 Imodium Multi-Symptom Relief Loperamide HCl / Simethicone J and J Consumer Perrigo
9/7/2018 Combivir Lamivudine / Zidovudine ViiV Healthcare Cipla
9/7/2018 Sandostatin Octreotide Acetate Novartis USV North America
9/10/2018 Glucophage XR Metformin HCl Bristol-Myers Squibb Prinston
9/10/2018 Magnesium Sulfate In Dextrose 5% Plastic Container Magnesium Sulfate In Dextrose 5% Plastric Container Hospira Mylan
9/10/2018 Yasmin Drospirenone / Ethinyl Estradiol Bayer Cyndea Pharma
9/11/2018 Atelvia Risedronate Sodium Apil Zydus
9/11/2018 Mepron Atovaquone GlaxoSmithKline Lupin
9/11/2018 BICNU Carmustine Emcure Pharms Navinta
9/14/2018 Inspra Eplerenone GD Searle Breckenridge
9/14/2018 Magnesium Sulfate in Plastic Container Magnesium Sulfate in Plastic Container Hospira Mylan
9/14/2018 Vagifem Estradiol Novo Nordisk Glenmark
9/14/2018 Clolar Clofarabine Genzyme Ingenus Pharms
9/17/2018 Norvir Ritonavir AbbVie Hetero Labs
9/17/2018 Norvir Ritonavir AbbVie Aurobindo
9/17/2018 Norvir Ritonavir AbbVie Amneal
9/18/2018 Plan B One-Step Levonorgestrel FDN Consumer Apotex
9/18/2018 Achromycin V Tetracycline HCl Heritage Pharma Amneal
9/19/2018 Aloxi Palonosetron HCl Helsinn Sagent
9/19/2018 Aloxi Palonosetron HCl Helsinn Qilu Pharm 
9/19/2018 Aloxi Palonosetron HCl Helsinn Sagent
9/19/2018 Abilify Aripiprazole Otsuka Mylan
9/19/2018 Aloxi Palonosetron HCl Helsinn Cipla
9/19/2018 Aloxi Palonosetron HCl Helsinn Mylan
9/19/2018 Aloxi Palonosetron HCl Helsinn Fresenius Kabi USA
9/19/2018 Aloxi Palonosetron HCl Helsinn Fresenius Kabi USA
9/19/2018 Aloxi Palonosetron HCl Helsinn Hospira
9/19/2018 Focalin Dexmethylphenidate HCl Novartis Cediprof
9/19/2018 Aloxi Palonosetron HCl Helsinn Virtus Pharm
9/21/2018 Sustiva Efavirenz Bristol-Myers Squibb Aurobindo Pharma
9/21/2018 Albenza Albendazole Impax Labs Cipla
9/24/2018 Zithromax Azithromycin Pfizer CSPC Ouyi Pharm
9/24/2018 Reyataz Atazanavir Sulfate Bristol-Myers Squibb Mylan
9/24/2018 Skelaxin Metaxalone King Pharms Appco Pharma
9/24/2018 Zyprexa Olanzapine Eli Lilly Jiangsu Hansoh Pharm
9/24/2018 Vibramycin Doxycycline Hyclate Pfizer Ajanta Pharma
9/24/2018 Glucophage XR Metformin HCl Bristol-Myers Squibb Yichang Humanwell
9/26/2018 Children's Motrin Ibuprofen J and J Consumer Guardian Drug
9/28/2018 Lovenox (Preservative Free) Enoxaparin Sodium Sanofi Aventis Apotex
9/28/2018 Solodyn Minocycline HCl Medicis Aurobindo Pharma
9/28/2018 Avelox Moxifloxacin HCl Bayer Sunshine Lake
9/28/2018 Lidex Fluocinonide Cnty Line Pharms Teligent Pharma
9/28/2018 Seroquel XR Quetiapine Fumarate AstraZeneca Alignscience Pharma
9/28/2018 Aubagio Teriflunomide Sanofi Aventis Amneal
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