ANDA Approvals

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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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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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Updated: May 25, 2018:

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