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 |