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ANDA Approvals

ANDA Tables Fall 2014

Approval Date Reference Listed Drug Generic Drug Name NDA Holder ANDA Applicant
10/3/2011 Propecia Finasteride Merck Sun Pharma Global
10/3/2011 Unipen Nafcillin Sodium Wyeth Acic Fine Chems
10/4/2011   Keppra XR Levetiracetam Ucb Inc Anchen Pharms
10/06/2011   Lamictal Lamotrigine Glaxosmithkline Unichem Labs Ltd
10/06/2011   Leustatin Cladribine Janssen Pharms Onco Therapies Ltd
10/06/2011   Neurontin Gabapentin Pfizer Pharms Aurobindo Pharma Ltd
10/07/2011   Retrovir Zidovudine Viiv Hlthcare Hec Pharm Inc
10/13/2011   Keppra XR Levetiracetam Ucb Inc Hikma Farmaceutica
10/17/2011   Keppra XR Levetiracetam Ucb Inc Lupin Ltd
10/17/2011   Derma-Smoothe/FS Fluocinolone Acetonide Hill Dermac Identi Pharms Inc
10/17/2011   Derma-Smoothe/FS Fluocinolone Acetonide Hill Dermac Identi Pharms Inc
10/17/2011   Derma-Smoothe/FS Fluocinolone Acetonide Hill Dermac Identi Pharms Inc
10/18/2011   Marcaine Hydrochloride Bupivacaine Hydrochloride Hospira Sagent Strides
10/18/2011   Marcaine Hydrochloride Bupivacaine Hydrochloride Hospira Sagent Strides
10/18/2011   Marcaine Hydrochloride Bupivacaine Hydrochloride Hospira Sagent Strides
10/18/2011   MS Contin Morphine Sulfate Purdue Pharma LP Mylan Pharms Inc
10/19/2011 Robinul Glycopyrrolate Shionogi Inc Boca Pharma
10/19/2011   Zinecard Dexrazoxane Hydrochloride Pharmacia And Upjohn Mylan Institutional
10/21/2011   Robaxin Methocarbamol Schwarz Pharma Austarpharma Llc
10/24/2011   Zyprexa Olanzapine Lilly Teva Pharms
10/24/2011   Zyprexa Olanzapine Lilly Dr Reddys Labs Ltd
10/24/2011   Zyprexa Olanzapine Lilly Par Pharm
10/24/2011   Zyprexa Olanzapine Lilly Apotex Inc
10/24/2011   Zyprexa Olanzapine Lilly Innopharma Llc
10/24/2011   Tenuate Dospan Diethylpropion Hydrochloride Watson Pharms Lannett Holdings Inc
10/25/2011   Adderall Dextroamphetamine Sulfate Teva And Barr Pharmaceuticals Mikart
10/25/2011   Zyprexa Olanzapine Lilly Torrent Pharms Llc
10/25/2011   Loseasonique (Generic Drug) Ethinyl Estradiol; Levonorgestrel Teva Womens Watson Labs
10/26/2011   Cefotetan Cefotetan Disodium App Pharms West-Ward Pharm Corp
10/26/2011   Cefotetan Cefotetan Disodium App Pharms West-Ward Pharm Corp
10/26/2011   Merrem Meropenem Astrazeneca Acs Dobfar
10/26/2011   Loseasonique (Generic Drug) Ethinyl Estradiol; Levonorgestrel Teva Womens Lupin Ltd
10/27/2011   Cellcept Mycophenolate Mofetil Allergan Dr Reddys Labs Ltd
10/27/2011   Gastrocrom Cromolyn Sodium Azur Pharma Pack Pharms Llc
10/28/2011   Cardizem CD Diltiazem Hydrochloride Valeant Intl Sun Pharma Global
10/28/2011   Doxil Doxorubicin Hydrochloride Janssen Pharms Onco Therapies Ltd
10/31/2011   Elestat Epinastine Hydrochloride Allergan Apotex
10/31/2011   Elestat Epinastine Hydrochloride Allergan Pharmaforce
10/31/2011   Elestat Epinastine Hydrochloride Allergan Sun Pharm Inds
10/31/2011   Anaprox Aurobindo Pharma Ltd Allergan Aurobindo Pharma Ltd
11/03/2011   Cyklokapron Tranexamic Acid Pharmacia And Upjohn Bioniche Pharma
11/04/2011   Plendil Felodipine Astrazeneca Endo Pharms
11/04/2011   Gabitril Tiagabine Hydrochloride Tiagabine Hydrochloride Sun Pharm Inds
11/04/2011   Risperdal Risperidone Janssen Pharms Jubilant Organosys
11/04/2011   Cellcept Mycophenolate Mofetil Roche Palo Alkem Labs Ltd
11/07/2011   XyzalL Levocetirizine Dihydrochloride Levocetirizine Dihydrochloride Synthon Pharms
11/08/2011   Naprosyn Naproxen Roche Palo Aurobindo Pharma Usa
11/09/2011   Carboplatin Carboplatin Teva Parenteral / Pharmachemie Onco Therapies Ltd
11/10/2011   Tylenol With Codein Acetaminophen; Codeine Phosphate Ortho-McNeil Pharma Vintage Pharms
11/10/2011   Kadian Morphine Sulfate Actavis Elizabeth Watson Labs
11/16/2011   Primaxin Cilastatin Sodium; Imipenem Merck Hospira Inc
11/16/2011   Primaxin Cilastatin Sodium; Imipenem Merck Hospira Inc
11/16/2011   Teveten Eprosartan Mesylate Abbott Mylan Pharms Inc
11/17/2011   Epivir Lamivudine Viiv Hlthcare Aurobindo Pharma Ltd
11/17/2011   Cyklokapron Tranexamic Acid Pharmacia And Upjohn Versapharm Inc
11/18/2011   Buphenyl Sodium Phenylbutyrate Medicis Ampolgen
11/21/2011   Arava Leflunomide Sanofi Aventis US Alembic Pharms Ltd
11/23/2011   Loseasonique (Generic Drug) Ethinyl Estradiol; Levonorgestrel Teva Womens Vintage Pharms
11/23/2011   Carboplatin Carboplatin Teva Parenteral / Pharmachemie Onco Therapies Ltd
11/25/2011   Carbatrol Carbamazepine Shire Apotex Inc
11/28/2011   Lovenox Enoxaparin Sodium Sanofi Aventis US Sandoz Inc
11/28/2011   Yaz Drospirenone; Ethinyl Estradiol Bayer Hlthcare Watson Labs
11/28/2011   Ultram Tramadol Hydrochloride Janssen Pharms Alvogen
11/28/2011   Plendil Felodipine Astrazeneca Torrent Pharms Ltd
11/29/2011   Risperdal Risperidone Janssen Pharms Prinston Inc
11/30/2011   Lipitor Atorvastatin Calcium Pfizer Ranbaxy Labs Ltd
11/30/2011   Solodyn Minocycline Hydrochloride Medicis Lupin Ltd
12/01/2011   Ritalin LA Methylphenidate Hydrochloride Novartis Actavis
12/02/2011   Epivir Lamivudine Viiv Hlthcare Apotex
12/06/2011   Pamine Methscopolamine Bromide Nycomed US Breckenridge Pharm
12/06/2011   Catapres Clonidine Hydrochloride Boehringer Ingelheim Alembic Pharms Ltd
12/06/2011   Sanctura Trospium Chloride Allergan Apotex
12/07/2011   Glucophage Metformin Hydrochloride Bristol Myers Squibb Apotex
12/07/2011   Ultram Tramadol Hydrochloride Valeant Intl Sun Pharma Global
12/09/2011 Dyazide Hydrochlorothiazide; Triameterene Glaxosmithkline Lannett Holdings Inc
12/12/2011 Vfend Voriconazole Pfizer Sandoz Inc
12/13/2011 Ritalin LA Methylphenidate Hydrochloride Novartis Actavis
12/13/2011 Cytarabine Cytarabine Hospira Onco Therapies Ltd
12/13/2011 Cytarabine Cytarabine Hospira Onco Therapies Ltd
12/13/2011 Cytarabine Cytarabine Hospira Onco Therapies Ltd
12/14/2011 Doryx Doxycycline Hyclate Mayne Pharma Actavis Elizabeth
12/15/2011 Toprol XL (Lopressor) Metoprolol Succinate Novartis Mylan Pharms Inc
12/16/2011 Camptosar Irinotecan Hydrochloride Pfizer Jiangsu Hengrui Med
12/16/2011 Felbamate Felbamate Meda Pharms Amneal Pharms
12/19/2011 Keppra XR Levetiracetam UCB Inc Mylan Pharms Inc
12/20/2011 Vibramycin Doxycyline Pfizer Heritage Pharms Inc
12/20/2011 Augmentin / Clavamox Amoxicillin; Clavulante Potassium Glaxosmithkline / Pfizer Aurobindo Pharma Ltd
12/20/2011 Augmentin / Clavamox Amoxicillin; Clavulante Potassium Glaxosmithkline / Pfizer Aurobindo Pharma Ltd
12/21/2011 Kayexalate Sodium Polystyrene Sulfonate Sanofi Aventis US Cedar Pharms
12/21/2011 Unasyn Ampicillin Sodium; Sulbactam Sodiu Pfizer Hospira Inc
12/21/2011 Primaxin Cilastatin Sodium; Imipenem Merck Acs Dobfar
12/21/2011 Unasyn Ampicillin Sodium; Sulbactam Sodiu Pfizer Hospira Inc
12/21/2011 Unasyn Ampicillin Sodium; Sulbactam Sodiu Pfizer Hospira Inc
12/21/2011 Fludara Fludarabine Phosphate Teva Parenteral / Sandoz Onco Therapies Ltd
12/22/2011 Clarinex Desloratadine Schering Plough Perrigo R and D
12/22/2011 Generess Fe Norethindrone; Ethinyl Estradiol Watson Pharms Novast Labs Ltd
12/22/2011 Ortho-Novum 7/7/7-28 Ethinyl Estradiol; Norethindrone Janssen Pharms Novast Labs Ltd
12/22/2011 Ovcon-35 Ethinyl Estradiol; Norethindrone Warner Chilcott Novast Labs Ltd
12/22/2011 Ortho-Novum Ethinyl Estradiol; Norethindrone Janssen Pharms Novast Labs Ltd
12/23/2011 Tricor Fenofibrate Abbott Labs Pharm Lupin Ltd
12/23/2011 Urso Forte Ursodiol Aptalis Pharma US Watson Labs Inc
12/30/2011 Osmoprep Sodium Phosphate, Diabasic anhydrous; Sodium Phosphate, Monobasic, Monohydrate Salix Novel Labs Inc
12/30/2011 Relafen Nabumetone Smithkline Beecham Apotex Inc
12/30/2011 Isoptin SR Verapamil Hydrochloride Pfizer Sun Pharm Inds

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