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ANDA Approvals
2011/2012
| 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 |
GENERICally Speaking Winter 2011/2012
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