ANDA Approvals

Summer 2018

GENERICally Speaking
Approval Date Reference Listed Drug Generic Drug Name NDA Holder ANDA Applicant
4/5/2018 Loprox Ciclopirox Medicis Teligent Pharma
4/6/2018 Invega Paliperidone Janssen Sun Pharma
4/6/2018 Zovirax Acyclovir Valeant Alembic
4/9/2018 Fazaclo ODT Clozapine Jazz Barr Labs
4/9/2018 Diovan Valsartan Novartis Square Pharms
4/9/2018 Truvada Emtricitabine / Tenofovir Disoproxil Fumarate Gilead Mylan
4/9/2018 Zithromax Azithromycin Pfizer Epic Pharma
4/9/2018 Miralax Polyethylene Glycol 3350 (OTC) Bayer Aurobindo
4/11/2018 Cubicin Daptomycin Cubist Pharms Fresenius Kabi USA
4/11/2018 Atacand HCT Candesartan Cilexetil and Hydrochlorothiazide ANI Pharms Prinston
4/11/2018 Dopamine HCl Dopamine HCl Hospira Hikma
4/11/2018 Claritin / Claritin Hives Relief Loratadine (OTC) Bayer Aurobindo
4/11/2018 Dermotic Flac Hill Dermac Patrin Pharma
4/12/2018 Zortress Everolimus Novartis West-Ward Pharms
4/13/2018 Pravachol Pravastatin Sodium Bristol-Myers Squibb Appco Pharma
4/16/2018 Adenocard Adenosine Astellas Fresenius Kabi USA
4/16/2018 Claritin / Claritin Hives Relief Loratadine (OTC) Bayer Aurobindo Pharma
4/16/2018 Invanz Ertapenem Sodium Merck Sharp & Dohme ACS Dobfar Spa
4/16/2018 Children's Claritin Loratadine (OTC) Bayer Sun Pharma Global
4/16/2018 Protopic Tacrolimus Leo Pharma Glenmark Pharms
4/17/2018 Avapro Irbesartan Sanofi Aventis Amneal
4/17/2018 Morphine Sulfate Morphine Sulfate West-Ward Pharms ANI Pharms
4/17/2018 Parnate Tranylcypromine Sulfate Concordia Pharms Kinedexe
4/17/2018 Actos Pioglitazone HCl Takeda Prinston
4/17/2018 Zavesca Miglustat Actelion Pharms Amerigen Pharms
4/17/2018 Cardura Doxazosin Mesylate Pfizer Appco Pharma
4/17/2018 Children's Motrin Ibuprofen (OTC) Johnson and Johnson Consumer Aurobindo
4/17/2018 Robaxin Methocarbamol West-Ward Pharms  Fresenius Kabi USA
4/17/2018 Clobex Clobetasol Propionate Galderma Labs Apotex
4/17/2018 Xeloda Capecitabine Hoffmann La Roche Eugia Pharma
4/18/2018 Xylocaine / Xylocaine Preservative Free Lidocaine HCl Fresenius Kabi USA Spectra Medical Devices
4/18/2018 Spectazole Econazole Nitrate Alvogen Malta Mylan
4/19/2018 Epivir Lamivudine ViiV Healthcare Strides
4/20/2018 Xenazine Tetrabenazine Valeant Lupin
4/23/2018 Medrol Methylprednisolone Pharmacia and Upjohn Zydus
4/23/2018 Sensipar Cinacalcet HCl Amgen Zydus
4/23/2018 Lidex Fluocinonide County Line Pharms Glasshouse Pharms
4/23/2018 Lidex Fluocinonide County Line Pharms MacLeods Pharms
4/23/2018 Sabril Vigabatrin Lundbeck Pharms Teva
4/24/2018 Aciphex Rabeprazole Sodium Eisai Alkem Labs
4/26/2018 Treanda Bendamustine HCl Cephalon Mylan
4/27/2018 Sustiva Efavirenz Bristol-Myers Squibb Hetero Labs
4/27/2018 Dilaudid Hydromorphone HCl Fresenius Kabi USA Eurohealth Int'l
4/27/2018 Aromasin Exemestane Pharmacia and Upjohn Cipla
4/27/2018 Vazculep Phenylephrine HCl Avadel Legacy Cipla
4/27/2018 Phenylephrine HCl Phenylephrine HCl West-Ward Pharm Cipla
4/30/2018 Bumex Bumetanide Validus Pharms Zydus Pharms
4/30/2018 Celebrex Celecoxib GD Searle Micro Labs
4/30/2018 Docetaxel Docetaxel Hospira Mylan
4/30/2018 Sensipar Cinacalcet HCl Amgen Strides Pharma
4/30/2018 Nexium Esomeprazole Magnesium AstraZeneca Sun Pharm
4/30/2018 Kapvay Clonidine HCl Concordia Pharms Mayne Pharma
4/30/2018 Oxycodone HCl Oxycodone HCl Genus LifeSciences / Vistapharm Specgx
5/1/2018 Plaquenil Hydroxychloroquine Sulfate Concordia Pharms Appco Pharma
5/3/2018 Ciloxan Ciprofloxacin HCl Novartis Altaire Pharms
5/4/2018 Norvasc Amlodipine Besylate Pfizer Sunshine Lake
5/4/2018 Bentyl / Bentyl Preservative Free Dicyclomine HCl Allergan Akorn
5/4/2018 Protonix IV Pantoprazole Sodium Wyeth Mylan
5/4/2018 Bloxiverz Neostigmine Methylsulfate Avadel Legacy Luitpold Pharms
5/4/2018 Diovan Valsartan Novartis Unichem Labs
5/4/2018 Anectine / Quelicin & Quelicin Preservative Free Succinylcholine Chloride Sandoz / Hospira  Zydus Pharms
5/4/2018 Vidaza Azacitidine Celgene Cipla
5/4/2018 Keppra Levetiracetam UCB Akorn
5/4/2018 Revatio Sildenafil Citrate Pfizer Ajanta Pharma
5/7/2018 Coreg CR Carvedilol Phosphate SmithKline Beecham Impax Labs
5/7/2018 Plavix Clopidogrel Bisulfate Sanofi Aventis Prinston
5/7/2018 Nitrostat Nitroglycerin Pfizer SigmaPharm Labs
5/7/2018 Robaxin / Robaxin-750 Methocarbamol Auxilium Pharms Granules India
5/7/2018 Namenda Memantine HCl Allergan CSPC Ouyi Pharm
5/7/2018 Cyclophosphamide Cyclophosphamide West-Ward Pharms STI Pharma
5/7/2018 Lodosyn Carbidopa Aton Zydus Pharms
5/8/2018 Plaquenil Hydroxychloroquine Sulfate Concordia Pharms Alkaloida ZRT
5/8/2018 Edecrin Ethacrynic Acid Aton Amneal
5/8/2018 Targretin Bexarotene Valeant Amerigen Pharms
5/9/2018 Calcium Chloride 10% in Plastic Container Calcium Chloride 10% in Plastic Container Hospira Int'l Medication Sys
5/11/2018 Zosyn Piperacillin / Tazobactam Wyeth Fresenius Kabi
5/11/2018 Zosyn Piperacillin / Tazobactam Wyeth Apollo Pharms
5/11/2018 Mephyton Phytonadione Valeant Amneal
5/14/2018 Medrol Methylprednisolone Pharmacia and Upjohn Tianjin Tianyao
5/14/2018 Neurontin Gabapentin Pfizer ACI Healthcare
5/14/2018 Niaspan Niacin AbbVie Jubilant Generics
5/15/2018 Arixtra Fondaparinux Sodium Mylan Jiangsu Hengrui Med
5/15/2018 Nexium 24HR Esomeprazole Magnesium (OTC) AstraZeneca Dr Reddys Labs
5/15/2018 Plaquenil Hydroxychloroquine Sulfate Concordia Pharms Amneal
5/16/2018 Welchol Colesevelam HCl Daiichi Sankyo Impax Labs
5/17/2018 Quillivant XR Methylphenidate HCl Nextwave Pharms Actavis
5/17/2018 Actigall Ursodiol Allergan Abhai
5/18/2018 Marinol Dronabinol AbbVie Lannett
5/18/2018 Welchol Colesevelam HCl Daiichi Sankyo Glenmark
5/18/2018 Zosyn Piperacillin / Tazobactam Wyeth Fresenius Kabi
5/18/2018 Nexium Esomeprazole Magnesium AstraZeneca HEC Pharm
5/18/2018 Triamcinolone Acetonide Triamcinolone Acetonide Mylan MacLeods Pharms
5/22/2018 Cialis Tadalafil Eli Lilly Teva
5/23/2018 Epiduo Adapalene / Benzoyl Peroxide Galderma Labs Tolmar
5/24/2018 Jalyn Dutasteride / Tamsulosin HCl GlaxoSmithKline Zydus Pharms
5/24/2018 Macrobid Nitrofurantoin (Monohydrate/ Macrocrystals) Alvogen Malta Sunny Pharmatech
5/25/2018 Zegerid Omeprazole / Sodium Bicarbonate Santarus Zydus Pharms
5/25/2018 Relpax Eletriptan Hydrobromide Pfizer Ameal
5/25/2018 Benzaclin Clindamycin Phosphate / Benzoyl Peroxide Valeant Taro
5/30/2018 Cardizem CD Diltiazem HCl Valeant Par
5/31/2018 Tylenol Acetaminophen (OTC) Johnson and Johnson Consumer Heritage Pharma
5/31/2018 Gelnique Oxybutynin Chloride Allergan Par
5/31/2018 Vibramycin Doxycycline Hyclate Pfizer Zydus Pharms
5/31/2018 Celebrex Celecoxib GD Searle Amneal
6/1/2018 Angiomax Bivalirudin The Medicines Co Mylan
6/1/2018 Corgard Nadolol US WorldMeds RiconPharma
6/4/2018 Anectine / Quelicin & Quelicin Preservative Free Succinylcholine Chloride Sandoz / Hospira  Renaissance SSA
6/4/2018 Vanos Fluocinonide Medicis Amneal
6/5/2018 Cubicin Daptomycin Cubist Pharms Mylan
6/5/2018 Onexton Clindamycin Phosphate / Benzoyl Peroxide Dow Pharm Taro
6/5/2018 Loestrin FE 1.5/30 Ethinyl Estradiol / Norethindrone Acetate / Ferrous Fumarate Apil Glenmark
6/5/2018 Loestrin FE 1.5/30 Ethinyl Estradiol / Norethindrone Acetate / Ferrous Fumarate Apil Glenmark
6/6/2018 Prilosec Omeprazole Magnesium (OTC) AstraZeneca Aurobindo
6/8/2018 Zymaxid Gatifloxacin Allergan Micro Labs
6/8/2018 Brevibloc Esmolol HCl Baxter Healthcare Mylan
6/8/2018 Brevibloc Esmolol HCl Baxter Healthcare Sagent Pharms
6/8/2018 Tamiflu Oseltamivir Phosphate Roche Strides Pharma
6/11/2018 Viagra Sildenafil Citrate Pfizer Torrent
6/11/2018 Viagra Sildenafil Citrate Pfizer Hetero Labs
6/11/2018 Viagra Sildenafil Citrate Pfizer Aurobindo
6/11/2018 Viagra Sildenafil Citrate Pfizer Rubicon Research
6/11/2018 Naropin Ropivacaine HCl Fresenius Kabi USA Inforlife
6/12/2018 Paxil CR Paroxetine HCl Apotex Sciecure Pharma
6/12/2018 Isuprel Isoproterenol HCl Hospira Cipla
6/13/2018 Vibramycin Doxycycline Hyclate Pfizer Alembic Pharms
6/14/2018 Suboxone Buprenorphine HCl / Naloxone HCl Indivior Dr Reddy's Labs
6/14/2018 Suboxone Buprenorphine HCl / Naloxone HCl Indivior Dr Reddy's Labs
6/14/2018 Suboxone Buprenorphine HCl / Naloxone HCl Indivior Mylan
6/14/2018 Wellbutrin XL Bupropion HCl Valeant  Yichang Humanwell
6/15/2018 Sustiva Efavirenz Bristol-Myers Squibb Cipla
6/15/2018 Naropin Ropivacaine HCl Fresenius Kabi USA Somerset Therapeutics
6/15/2018 Bloxiverz Neostigmine Methylsulfate Avadel Legacy Amneal
6/18/2018 Starlix Nateglinide Novartis Indicus Pharma
6/18/2018 Ancobon Flucytosine Valeant Recipharm
6/18/2018 Lipitor Atorvastatin Calcium Pfizer Graviti Pharms
6/18/2018 Isuprel Isoproterenol HCl Hospira Amphastar Pharms
6/19/2018 Effient Prasugrel Eli Lilly Amneal
6/19/2018 Fluocinonide Fluocinonide County Line Pharms Teligent Pharma
6/20/2018 Exelon Rivastigmine Novartis Mylan
6/21/2018 Sabril Vigadrone Lundbeck Pharms Aucta Pharms
6/21/2018 Makena Preservative Free Hydroxyprogesterone Caproate Amag Pharma Luitpold Pharms
6/22/2018 Estrostep FE Norethindrone Acetate / Ethinyl Estradiol Apil Mylan
6/22/2018 Avodart Dutasteride GlaxoSmithKline Pharmaceutics
6/22/2018 Cipro Ciprofloxacin HCl Bayer Yiling Pharm
6/22/2018 Klor-Con Potassium Chloride Upsher-Smith Yichang Humanwell
6/25/2018 Reyataz Atazanavir Sulfate Bristol-Myers Squibb Aurobindo
6/25/2018 Invanz Ertapenem Sodium Merck Sharp & Dohme Aurobindo
6/26/2018 Nicorette Nicotine Polacrilex (OTC) GlaxoSmithKline Watson
6/27/2018 Depo-Medrol Methylprednisolone Acetate Pharmacia and Upjohn Sagent Pharms
6/27/2018 Viagra Sildenafil Citrate Pfizer Amneal
6/28/2018 Cancidas Caspofungin Acetate Merck Sandoz
6/29/2018 Atelvia Risedronate Sodium Apil Impax Labs
6/29/2018 Zometa Zoledronic Novartis Gland Pharma
6/29/2018 Zometa Zoledronic Acid Novartis Gland Pharma
6/29/2018 EMLA Lidocaine / Prilocaine Actavis Teligent Pharma
6/29/2018 Seasonale Icelevia Teva Aurobindo
6/29/2018 Motrin IB Ibuprofen (OTC) Johnson and Johnson Consumer Strides Pharma
6/29/2018 Advil Liqui-Gels / Advil Migraine Liqui-Gels Ibuprofen Pfizer Aurobindo
6/29/2018 Benicar Olmesartan Medoxomil Daiichi Sankyo Sciegen Pharms
6/29/2018 Maxzide-25 / Maxzide Triamterene / Hydrochlorothiazide Mylan Zydus Pharms
6/29/2018 Claritin Loratadine (OTC) Bayer Aurobindo
6/29/2018 Adalat CC Nifedipine Alvogen Zydus Pharms
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