ANDA Approvals

Fall 2017

GENERICally Speaking
Approval Date Reference Listed Drug Generic Drug Name NDA Holder ANDA Applicant
7/5/2017 Focalin XR Dexmethylphenidate HCl Novartis Teva
7/5/2017 Focalin XR Dexmethylphenidate HCl Novartis Impax Labs
7/5/2017 Azor Amlodipine / Olmesartan Medoxomil Daiichi Sankyo Glenmark
7/6/2017 Topotecan HCl Topotecan HCl Hospira Accord Healthcare
7/6/2017 Angiomax Bivalirudin The Medicines Co Apotex
7/6/2017 Morphine Sulfate Morphine Sulfate West-Ward Pharms Hi-Tech Pharmacal
7/7/2017 Ancobon Flucytosine Valeant Novel Labs
7/7/2017 Travatan Z Travoprost Novartis Mylan
7/7/2017 Busulfex Busulfan Otsuka Sandoz
7/7/2017 Xenazine Tetrabenazine Valeant Actavis
7/7/2017 Zyvox Linezolid Pharmacia and Upjohn HQ Specialty Pharma
7/7/2017 Cardura Doxazosin Mesylate Pfizer Zydus
7/10/2017 Namenda Memantine HCl Forest Labs Zydus
7/12/2017 Androgel Testosterone AbbVie Perrigo
7/12/2017 Effient Prasugrel Eli Lilly and Co Mylan
7/13/2017 Inspra Eplerenone GD Searle Accord Healthcare
7/14/2017 Concerta Methylphenidate HCl Janssen Impax Labs
7/17/2017 Dermotic Fluocinolone Acetonide Hill Dermac Perrigo
7/17/2017 Ethyol Amifostine Clinigen Healthcare Mylan
7/17/2017 Cyklokapron Tranexamic Acid Pharmacia and Upjohn Zydus
7/17/2017 Azor Amlodipine / Olmesartan Medoxomil Daiichi Sankyo Alembic
7/17/2017 Renvela Sevelamer Carbonate Genzyme Aurobindo
7/18/2017 Yaz Drospirenone / Ethinyl Estradiol Bayer PII
7/18/2017 Robaxin Methocarbamol West-Ward Pharms Sagent
7/19/2017 Indocin Indomethacin Sodium Recordati Rare Navinta
7/20/2017 Erygel Erythromycin Mylan Teligent Pharma
7/21/2017 Asacol HD Mesalamine Apil Zydus
7/21/2017 Hyzaar Losartan Potassium / Hydrochlorothiazide Merck Sharp Dohme Unichem Labs
7/21/2017 Cetirizine HCl Allergy (OTC) Cetirizine HCl Allergy (OTC) Bionpharma Strides Pharma
7/21/2017 Lidex Fluocinonide Cnty Line Pharms Novel Labs
7/21/2017 Sodium Chloride 0.9% Sodium Chloride 0.9% Hospira / Baxter Healthcare & Hospira Spectra Mdcl Devices
7/21/2017 Vagifem Estradiol Novo Nordisk Teva
7/21/2017 Edecrin Ethacrynic Acid Aton Par Pharm
7/21/2017 Robaxin / Robaxin-750 Methocarbamol Auxilium Pharms Beximco Pharms
7/21/2017 Oxycodone HCl Oxycodone HCl Lehigh Valley / Vistapharm Abhai
7/24/2017 Desonide Desonide Perrigo Glenmark
7/25/2017 Micardis Telmisartan Boehringer Ingelheim Cadila Pharms
7/26/2017 Patanol Olopatadine HCl Novartis  Cipla
7/26/2017 Aromasin Exemestane Pharmacia and Upjohn Upsher-Smith
7/27/2017 Rogaine (OTC) Minoxidil (For Men) (OTC) Johnson and Johnson Watson
7/27/2017 Rogaine (OTC) Minoxidil (For Women) (OTC) Johnson and Johnson Watson
7/27/2017 Calcium Chloride 10% Calcium Chloride 10% Hospira Luitpold
7/28/2017 Delsym (OTC) Dextromethorphan Polistirex (OTC) Reckitt Benckiser Amneal
7/28/2017 Concerta Methylphenidate HCl Janssen Osmotica
7/28/2017 Viroptic Trifluridine Monarch Pharms Hi-Tech Pharmacal
7/28/2017 Enablex Darifenacin Apil MacLeods Pharms
7/28/2017 Corgard Nadolol US WorldMeds Zydus
7/28/2017 Monodox Doxycycline Aqua Pharms Alembic
7/31/2017 Zovirax Acyclovir Valeant Glenmark
7/31/2017 Crestor Rosuvastatin Calcium IPR Lupin
7/31/2017 Entocort EC Budesonide Perrigo Amneal
7/31/2017 Zovirax Acyclovir Valeant Bermuda Tolmar
7/31/2017 Sulfamylon Mafenide Acetate Mylan RiconPharma
7/31/2017 Temodar Temozolomide Merck Sharp Dohme Zydus
7/31/2017 Olux Clobetasol Propionate Mylan Ingenus Pharms
7/31/2017 Viramune XR Nevirapine Boehringer Ingelheim Sciegen Pharms
7/31/2017 Robaxin Methocarbamol West-Ward Pharms Somerset Theraps
7/31/2017 Lidex Fluocinonide Cnty Line Pharms Novel Labs
8/2/2017 Isuprel Isoproterenol HCl Hospira Nexus Pharms
8/3/2017 Namenda XR Memantine HCl Forest Labs Zydus
8/3/2017 Viramune Nevirapine Boehringer Ingelheim Cipla
8/4/2017 Zanaflex Tizanidine HCl Acorda Jubilant Generics
8/7/2017 Roxicodone Oxycodone HCl Mallinckrodt Ascent Pharms
8/7/2017 Oxycodone HCl Oxycodone HCl Lehigh Valley Hi-Tech Pharmacal
8/8/2017 Cardizem CD Diltiazem HCl Valeant Zydus
8/9/2017 Taxotere Docetaxel Accord Healthcare / Sanofi Aventis Jiangsu Hengrui Med
8/10/2017 Oxycodone HCl Oxycodone HCl Lehigh Valley / Vistapharm Hi-Tech Pharmacal
8/11/2017 Fosrenol Lanthanum Carbonate Shire Natco Pharma
8/11/2017 Relpax Eletriptan Hydrobromide Pfizer Mylan
8/11/2017 Tiazac Diltiazem HCl Valeant  Zydus
8/11/2017 Flomax Tamsulosin HCl Boehringer Ingelheim Alkem Labs
8/11/2017 Feldene Piroxicam Pfizer Hikma Pharms
8/11/2017 Doxorubicin HCl Doxorubicin HCl Pharmacia and Upjohn Gland Pharma
8/14/2017 Astelin Azelastine HCl Mylan Zydus
8/14/2017 Azor Amlodipine / Olmesartan Medoxomil Daiichi Sankyo Alkem Labs
8/15/2017 Micardis HCT Telmisartan / Hydrochlorothiazide Boehringer Ingelheim Zydus
8/15/2017 Mestinon Pyridostigmine Bromide Valeant Kinedexe
8/15/2017 Oxycodone HCl Oxycodone HCl Lehigh Valley Pharm Assoc
8/16/2017 Zovirax Acyclovir Mylan Carlsbad Technology
8/16/2017 Provigil Modafinil Cephalon Appco Pharma
8/18/2017 Brisdelle Paroxetine Mesylate Sebela Prinston
8/18/2017 Nexium 24Hr (OTC) Esomeprazole Magnesium (OTC) AstraZeneca Perrigo
8/18/2017 Astelin Azelastine HCl Mylan Alkem Labs
8/21/2017 Wellbutrin XL Bupropion HCl Valeant Sinotherapeutics
8/22/2017 DDAVP Desmopressin Acetate Ferring Sagent
8/22/2017 DDAVP Desmopressin Acetate Ferring Sagent
8/22/2017 Geodon Ziprasidone HCl Pfizer Zydus
8/23/2017 Atacand Candesartan Cilexetil AstraZeneca Zydus
8/23/2017 Myfortic Mycophenolic Acid Novartis Accord Healthcare
8/23/2017 Akovaz Ephedrine Sulfate Flamel Ireland Sandoz
8/25/2017 Prograf Tacrolimus Astellas Hospira
8/25/2017 Baraclude Entecavir Bristol Myers Squibb Accord Healthcare
8/25/2017 Zetia Ezetimibe MSD Aurobindo
8/28/2017 Astelin Azelastine HCl Mylan Amneal
8/29/2017 Relpax Eletriptan Hydrobromide Pfizer Ajanta
8/29/2017 Aggrenox Aspirin / Dipyridamole Boehringer Ingelheim Zydus
8/30/2017 Oxycodone HCl Oxycodone HCl Lehigh Valley ANI Pharms
8/30/2017 Prevacid Lansoprazole Takeda Inventia Healthcare
8/30/2017 Nimbex Cisatracurium Besylate AbbVie Jiangsu Hengrui Med
8/31/2017 Camptosar Irinotecan HCl Pfizer Intas Pharms
8/31/2017 Aricept Donepezil HCl Eisai Zydus
8/31/2017 Cellcept Mycophenolate Mofetil HCl Roche Palo Zydus
8/31/2017 Comtan Entacapone Orion Pharma Ajanta
8/31/2017 Skelaxin Metaxalone King Pharms Sciegen Pharms
8/31/2017 Docetaxel Docetaxel Hospira Ingenus Pharms
9/1/2017 Nexium Esomeprazole Magnesium AstraZeneca Kremers Urban
9/6/2017 Haldol Haloperidol Janssen Akorn
9/6/2017 Eloxatin Oxaliplatin Sanofi Aventis / Teva Sanja Pharms
9/6/2017 Mucinex (OTC) Guaifenesin (OTC) Reckitt Benckiser Guardian Pharms
9/6/2017 Oxycodone HCl Oxycodone HCl Lehigh Valley Wes Pharma Inc
9/7/2017 Tricor Fenofibrate AbbVie Sun Pharm 
9/7/2017 Prometrium Progesterone Virtus Pharms Amneal
9/8/2017 Rythmol SR Propafenone HCl GlaxoSmithKline Glenmark
9/8/2017 Kenalog Triamcinolone Acetonide Ranbaxy RiconPharma
9/11/2017 Intermezzo Zolpidem Tartrate Purdue Pharma Par
9/11/2017 Urocit-K Potassium Citrate Mission Pharma Strides Pharma
9/11/2017 Minastrin 24 FE Norethindrone Acetate / Ethinyl Estradiol / Ferrous Fumarate Apil Amneal
9/12/2017 Minastrin 24 FE Norethindrone Acetate / Ethinyl Estradiol / Ferrous Fumarate Apil Mylan
9/12/2017 Flagyl Metronidazole GD Searle Lupin
9/14/2017 Tamiflu Oseltamivir Phosphate Roche MacLeods Pharms
9/14/2017 Tamiflu Oseltamivir Phosphate Roche Nesher Pharms
9/14/2017 Provigil Modafinil Cephalon Zydus
9/15/2017 D.H.E. 45 Dihydroergotamine Mesylate Valeant Hikma Pharms
9/15/2017 Desonide Desonide Perrigo Glenmark
9/18/2017 Testim Testosterone Auxilium Pharms Actavis
9/18/2017 Triamcinolone Acetonide Triamcinolone Acetonide Mylan Teligent Pharma
9/19/2017 Lovaza Omega-3-Acid Ethyl Esters SmithKline Beecham Strides Pharma
9/19/2017 Aricept Donepezil HCl Eisai Cadila Pharms
9/19/2017 Sporanox Itraconazole Janssen Zydus
9/19/2017 Nitrostat Nitroglycerin Pfizer Glenmark
9/19/2017 Avalide Irbesartan / Hydrochlorothiazide Sanofi Aventis Unichem Labs
9/19/2017 Sodium Chloride 0.9% Sodium Chloride 0.9% B Braun / Baxter Healthcare / Hospira / ICU Medical Fresenius Kabi USA
9/19/2017 Precedex Dexmedetomidine HCl Hospira Jiangsu Hengrui Med
9/22/2017 Dacogen Decitabine Otsuka Pharm Chemi Spa
9/22/2017 Astepro Azelastine HCl Mylan Speciality West-Ward Pharms
9/22/2017 Azor Amlodipine / Olmesartan Medoxomil Daiichi Sankyo Zydus
9/22/2017 Avelox Moxifloxacin HCl Bayer MSN Labs
9/22/2017 Clobex Clobetasol Propionate Galderma Labs Lupin
9/25/201 Focalin Dexmethylphenidate HCl Novartis Lannett
9/25/2017 Bloxiverz Neostigmine Methylsulfate Eclat Pharms Amphastar Pharms
9/27/2017 Isopto Carpine Pilocarpine HCl Novartis Akorn
9/27/2017 Acticlate Doxycycline Hyclate Aqua Pharms Lupin
9/28/2017 Cyklokapron Tranexamic Acid Pharmacia and Upjohn Akorn
9/28/2017 Pentam Pentamidine Isethionate Fresenius Kabi USA Seton Pharms
9/28/2017 Prevacid Lansoprazole Takeda Kremers Urban
9/28/2017 Keppra XR Levetiracetam UCB Inc Pharmtak
9/28/2017 Exelon Rivastigmine Tartrate Novartis Ajanta Pharma
9/28/2017 Entocort EC Budesonide Perrigo Sciecure Pharma
9/28/2017 Renvela Sevelamer Carbonate Genzyme Dr Reddys
9/29/2017 Cancidas Caspofungin Acetate Merck Gland Pharma
9/29/2017 Prevacid 24 HR (OTC) Lansoprazole (OTC) GlaxoSmithKline Kremers Urban
9/29/2017 Desferal Deferoxamine Mesylate Novartis Gland Pharma
9/29/2017 Cancidas Caspofungin Acetate Merck Mylan
9/29/2017 Monodox Doxycycline Aqua Pharms Mayne Pharma
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