ANDA Approvals

Summer 2013

GENERICally Speaking
Approval Date Reference Listed Drug Generic Drug Name NDA Holder ANDA Applicant
4/2/2013 Zithromax Azithromycin Pfizer Sun Pharm Indus
4/3/2013 Ampicillin Sodium Ampicillin Sodium Sandoz ACS Dobfar Spa
4/3/2013 Ampicillin Sodium Ampicillin Sodium Sandoz ACS Dobfar Spa
4/3/2013 Lunesta Eszopiclone Sunovion Pharms Inc Sun Pharma Global
4/3/2013 Zovirax Acyclovir Valeant Int'l Mylan Pharms
4/4/2013 Soriatane Acitretin Stiefel Labs Barr Labs
4/4/2013 Gastrocrom Cromolyn Sodium Meda Pharms Micro Labs
4/4/2013 Soriatane Acitretin Stiefel Labs Barr Labs
4/4/2013 Cleocin Phosphate in 5% Dextrose in Plastic Container Clindamycin Phosphate in 5% Dextrose in Plastic Container Pharmacia and Upjohn Akorn
4/5/2013 Lipitor Atorvastatin Calcium Pfizer Kudco Ireland
4/5/2013 Reclast Zoledronic Acid Novartis Hospira
4/8/2013 Risperdal Risperidone Janssen Pharms Sun Pharm Indus
4/10/2013 Seasonique Daysee Teva Branded Pharm Lupin
4/10/2013 Orapred ODT Prednisolone Sodium Phosphate Shionogi Mylan Pharms
4/12/2013 Percocet Oxycodone / Acetaminophen Vintage Pharms Actavis Elizabeth
4/15/2013 Acetaminophen and Codeine Phosphate; Tylenol w/Codeine No. 3; Acetaminophen and Codeine Phosphate Acetaminophen / Codeine Phosphate Mallinckrodt; Janssen Pharms; Teva Aurolife Pharma
4/16/2013 Actoplus Met Pioglitazone Hydrochloride / Metformin Hydrochloride Takeda Pharms USA Sandoz
4/19/2013 Zegerid Omeprazole / Sodium Bicarbonate Santarus Par Pharm
4/19/2013 Reglan Metoclopramide Hydrochloride Baxter Healthcare BD RX
4/19/2013 Diovan HCT Valsartan / Hydrochlorothiazide Novartis MacLeods Pharms
4/23/2013 Luvox CR Fluvoxamine Maleate Jazz Pharms Actavis Elizabeth
4/23/2013 Imitrex Sumatriptan Succinate GlaxoSmithKline Aurobindo Pharma
4/24/2013 Promethazine Hydrochloride and Codeine Phosphate Promethazine Hydrochloride / Codeine Phosphate Actavis Mid Atlantic Amneal Pharms
4/24/2013 Ortho-Novum 7/7/7-28 Primella 7/7/7 Janssen Pharms Lupin
4/24/2013 Ortho-Novum 1/35-28 Primella 1/35 Janssen Pharms Lupin
4/25/2013 Duricef Cefadroxil Warner Chilcott Aurobindo Pharma
4/25/2013 Opana Oxymorphone Hydrochloride Endo Pharms Mallinckrodt Inc
4/25/2013 Procardia Nifedipine Pfizer Emcure Pharms USA
4/26/2013 Xopenex Levalbuterol Hydrochloride Sunovion Teva Pharms USA
4/29/2013 Adderall XR 30 Amphetamine / Dextroamphetamine Shire Teva Pharms USA
4/29/2013 Lopressor Metoprolol Tartrate Novartis Claris LifeSciences
4/29/2013 Norvasc Amlodipine Besylate Pfizer Accord Healthcare
4/29/2013 Ocuflox Ofloxacin Allergan Altaire Pharms
4/29/2013 Accupril Quinapril Hydrochloride Pfizer Pharms Aurobindo Pharma
4/30/2013 Doryx Doxycycline Hyclate Mayne Pharma Heritage Pharms
4/30/2013 Cleocin Clindamycin Palmitate Hydrochloride Pharmacia and Upjohn Aurobindo Pharma
4/30/2013 Flomax Tamsulosin Hydrochloride Boehringer Ingelheim Aurobindo Pharma
5/3/2013 Atacand Candesartan Cilexetil AstraZeneca Sandoz
5/3/2013 Hydralazine Hydrochloride Hydralazine Hydrochloride Pliva Strides Arcolab
5/6/2013 Zyloprim Allopurinol Prometheus Labs Accord Healthcare
5/7/2013 Gemzar Gemcitabine Hydrochloride Eli Lilly Sagent Pharms
5/7/2013 Gemzar Gemcitabine Hydrochloride Eli Lilly Pharmaforce
5/7/2013 Gemzar Gemcitabine Hydrochloride Eli Lilly Jiangsu Hansoh Pharm
5/7/2013 Zometa Zoledronic Acid Novartis Pharms
5/7/2013 Gemcitabine Hydrochloride Gemcitabine Hydrochloride Hospira Dr Reddy's Labs
5/8/2013 Triaminolone Acetonide Triamcinolone Acetonide Morton Grove / Wockhardt Versapharm
5/9/2013 Arthrotec Diclofenac Sodium / Misoprostol GD Searle Sandoz
5/10/2013 Hydrocodone Bitartrate and Acetaminophen Hydrocodone Bitartrate / Acetaminophen Mikart PAI
5/13/2013 Minocycline Hydrochloride Minocycline Hydrochloride Teva Caraco
5/13/2013 Comtan Entacapone Orion Pharma Mylan Pharms
5/14/2013 Zomig Zolmitriptan IPR Glenmark Generics
5/14/2013 Zomig Zolmitriptan IPR Apotex
5/14/2013 Zomig-ZMT Zolmitriptan AstraZeneca Apotex
5/14/2013 Zomig Zolmitriptan AstraZeneca Glenmark Generics
5/14/2013 Zomig Zolmitriptan IPR Mylan Pharms
5/15/2013 Zomig-ZMT Zolmitriptan AstraZeneca Zydus Pharms USA
5/16/2013 Exelon Rivastigmine Tartrate Novartis Apotex
5/16/2013 Ultram Tramadol Hydrochloride Janssen Pharms Accord Healthcare
5/16/2013 Femara Letrozole Novartis Jiangsu Hengrui Med
5/21/2013 Imitrex Sumatriptan Succinate GlaxoSmithKline Hikma Pharms
5/24/2013 Rocaltrol Calcitriol Validus Pharms Banner Pharmacaps
5/24/2013 Sanctura XR Trospium Chloride Allergan Paddock
5/28/2013 Plavix Clopidogrel Bisulfate Sanofi Aventis US Actavis Totowa
5/28/2013 Vicoprofen Hydrocodone Bitartrate / Ibuprofen Abbvie Sun Pharm Indus
5/28/2013 Vfend Voriconazole Pfizer Mylan Pharms
5/28/2013 Metoprolol Tartrate Metoprolol Tartrate Mylan Alembic Pharms
5/29/2013 Dextroamphetamine Sulfate Dextroamphetamine Sulfate Outlook Pharms Tris Pharma
5/30/2013 Avodart Dutasteride GlaxoSmithKline Banner Pharmacaps
6/3/2013 Vistaril Hydroxyzine Pamoate Pfizer Emcure Pharms USA
6/3/2013 Depo-Testosterone Testosterone Cypionate Pharmacia and Upjohn Sun Pharm Indus
6/3/2013 Kadian Morphine Sulfate Watson Labs Upsher Smith
6/3/2013 Zometa Zoledronic Acid Novartis Hikma Farmaceutica
6/3/2013 Atacand HCT Candesartan Cilexetil / Hydrochlorothiazide AstraZeneca Apotex
6/3/2013 Atacand HCT Candesartan Cilexetil / Hydrochlorothiazide AstraZeneca Dr Reddy's Labs
6/5/2013 Levaquin Levofloxacin Janssen Pharms Claris LifeSciences
6/10/2013 Biaxin Clarithromycin Abbvie Allied Pharma
6/12/2013 Lexapro Escitalopram Oxalate Forest Labs Silarx Pharms
6/12/2013 Micronor Norethindrone Janssen Pharms Famy Care
6/13/2013 Cellcept Mycophenolate Mofetil Roche Palo Alkem Labs
6/13/2013 Catapres Clonidine Hydrochloride Boehringer Ingelheim Carlsbad
6/14/2013 Lamictal Lamotrigine GlaxoSmithKline Alkem Labs
6/14/2013 Cyklokapron Tranexamic Acid Pharmacia and Upjohn Custopharm
6/17/2013 Lamictal XR Lamotrigine GlaxoSmithKline Handa Pharms
6/18/2013 Rilutek Riluzole Covis Pharma Apotex
6/18/2013 Rilutek Riluzole Covis Pharma Glenmark Generics
6/18/2013 Rilutek Riluzole Covis Pharma Sun Pharm Indus
6/19/2013 Levaquin in Dextrose 5% in Plastic Container Levofloxacin in Dextrose 5% in Plastic Container Janssen Pharms Fresenius Kabi USA
6/19/2013 Lamictal XR Lamotrigine GlaxoSmithKline Dr Reddy's Labs
6/21/2013 Carbatrol Carbamazepine Shire Taro
6/21/2013 Skelaxin Metaxalone King Pharms Amneal Pharms
6/26/2013 Keppra Levetiracetam UCB Sagent Pharms
6/26/2013 Hycamtin Topotecan Hydrochloride GlaxoSmithKline Accord Healthcare
6/27/2013 Coumadin Warfarin Sodium Bristol-Myers Squibb IPCA Labs
6/27/2013 Fludeoxyglucose F18 Fludeoxyglucose F18 Weill Medical College UCLA Biomedical
6/27/2013 Ammonia N 13 Ammonia N 13 Feinstein UCLA Biomedical
6/28/2013 Tofranil-PM Imipramine Pamoate Mallinckrodt Mylan Pharms
6/28/2013 FLUORINE F-18 Sodium Fluoride F-18 GE Healthcare MCPRF

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