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

ANDA Tables Fall 2014

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GENERICally Speaking Winter 2011/2012

Oren D. Langer

Partner

Managing Partner, New York Office

Ryan M. Schultz