ANDA Approvals

Spring 2012

GENERICally Speaking
Approval Date Reference Listed Drug Generic Drug Name NDA Holder ANDA Applicant
1/9/2012 Flonase Fluticasone Propionate GlaxoSmithKline Wockhardt
1/12/2012 Famvir Famciclovir Novartis MacLeods Pharms
1/17/2012 Uroxatral Alfuzosin Hydrochloride Sanofi Aventis US Invagen Pharms
1/18/2012 Fortamet Metformin Hydrochloride Andrx Labs Inventia Hlthcare
1/19/2012 Amnesteem Myorisan Mylan Douglas Pharms
1/19/2012 Lopressor HCT Metoprolol Tartrate and Hydrochlorothiazide Novartis Sun Pharm Inds
1/19/2012 Ortho-Novum 1/35-28 Alyacen 1/35 Janssen Glenmark Generics
1/19/2012 Ortho-Novum 7/7/7-28 Alyacen 7/7/7 Janssen Glenmark Generics
1/19/2012 Alyacen 777 Glenmark Generics
1/20/2012 Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium Teva Aurobindo Pharma
1/20/2012 Amoxicillin and Clavulanate Potassium Amoxicillin and Clavulanate Potassium Teva Aurobindo Pharma
1/20/2012 Bascteriostatic Sodium Chloride 0.9% in Plastic Container Sodium Chloride 0.9% Hospira Hikma (Maple)
1/25/2012 MoviPrep Ascorbic Acid; Polyethylene Glycol 3350; Potassium Chloride; Sodium Ascorbate; Sodium Chloride; Sodium Sulfate Salix Pharmaceuticals Novel Labs
1/25/2012 Enulose Lactulose Actavis Mid Atlantic Fresenius Kabi
1/25/2012 Constulose Lactulose Actavis Mid Atlantic Fresenius Kabi
1/25/2012 Midazolam Hydrochloride Midazolam Hydrochloride Hospira Gland Pharma
1/25/2012 Hydrocodone Bitartrate and Acetaminphen Hydrocodone Bitartrate and Acetaminphen Mikart VistaPharm
1/27/2012 Microzide Hydrochlorothiazide Watson Labs Lannett
1/27/2012 Didrex Benzphetamine Hydrochloride Pharmacia and Upjohn Emcure Pharms
1/30/2012 Zyprexa Zydis Olanzapine Lilly Barr Labs
1/30/2012 Cytarabine Cytarabine App Pharms Onco Therapies
1/31/2012 Keppra Levetiracetam UCB Inc Pharmaforce
2/3/2012 Zanaflex Tizanidine Hydrochloride Acorda Apotex
2/3/2012 Nimbex Preservative Free Cisatracurium Besylate Preservative Free Abbott Labs Sandoz
2/3/2012 Nimbex Cisatracurium Besylate Abbott Labs Sandoz
2/6/2012 Paraplatin Carboplatin Bristol-Myers Squibb Actavis Totowa
2/7/2012 Requip Ropinirole Hydrochloride GlaxoSmithKline Apotex
2/7/2012 Precose Acarbose Bayer Hlthcare Emcure Pharms
2/8/2012 Doryx Doxycycline Hyclate Mayne Pharma Mylan
2/10/2012 Clarinex Desloratadine Schering Plough Mylan
2/14/2012 Camptosar Irinotecan Hydrocloride Pfizer Emcure Pharms
2/14/2012 Doxorubicin Hydrochloride Doxorubicin Hydrochloride Bedford Onco Therapies
2/15/2012 Doxorubicin Hydrochloride Doxorubicin Hydrochloride Bedford Sun Pharm Inds
2/16/2012 Protonix Pantoprazole Sodium Wyeth MacLeods Pharms
2/17/2012 Cefaclor Cefaclor Ranbaxy Yung Shin Pharm
2/17/2012 Atracurium Besylate Preservative Free Atracurium Besylate Preservative Free Bedford Sagent Pharms
2/17/2012 Atracurium Besylate Atracurium Besylate Bedford Sagent Pharms
2/17/2012 Hyzaar Losartan Potassium and Hydrochlorothiazide Merck Alembic
2/24/2012 Reva Naltrexone Hydrochloride Duramed Sun Pharma Global
2/27/2012 Methotrexate Sodium Methotrexate Preservative Free Bedford Pharmachemie BV
2/28/2012 Keppra Levetiracetam UCB Inc Hi-Tech Pharmacal
2/28/2012 Zyprexa Zydis Olanzapine Lilly Sun Pharm Inds
2/29/2012 Cefropozil Cefropozil Lupin Apotex
2/29/2012 Midazolam Hydrochloride Midazolam Hydrochloride Hospira Gland Pharma
2/29/2012 Nordette-28 Marlissa Duramed Glenmark Generics
2/29/2012 Loprox Ciclopirox Medicis Glenmark Generics
2/29/2012 Prometrium Progesterone Abbott Labs Teva
3/1/2012 Antara (Micronized) Fenofibrate (Micronized) Lupin Atlantis Dr. Reddys Labs
3/2/2012 Geodon Ziprasidone Hydrochloride Pfizer Lupin Pharms
3/2/2012 Geodon Ziprasidone Hydrochloride Pfizer Apotex
3/2/2012 Geodon Ziprasidone Hydrochloride Pfizer Dr. Reddys Labs
3/2/2012 Cyklokapron Tranexamic Acid Pharmacia and Upjohn Nexus Pharms
3/6/2012 Aldara Imiquimod Medicis Glenmark Generics
3/7/2012 Methimazole Methimazole Mylan Boca Pharma
3/8/2012 Mesnex Mesna Baxter Healthcare Mylan Institutional
3/8/2012 Activella Estradiol; Norethindrone Acetate Novo Nordisk Teva
3/8/2012 Diflunisal Diflunisal Teva Emcure Pharms
3/12/2012 Risperdal Risperidone Janssen Teva
3/12/2012 Depakote ER Divalproex Sodium Abbott Labs Dr. Reddys Labs
3/12/2012 Glucophage Metformin Hydrochloride Bristol Myers Squibb Marksans Pharma
3/12/2012 Robinul Glycopyrrolate Mikart Nexgen Pharma
3/14/2012 Lexapro Escitalopram Oxalate Forest Labs Ivax Sub Teva Pharms
3/14/2012 Lexapro Escitalopram Oxalate Forest Labs Amneal Pharms
3/15/2012 Depakote ER Divalproex Sodium Abbott Labs Dr. Reddys Labs
3/15/2012 Ritalin Methylphenidate Hydrochloride Novartis Sun Pharms IDNS Inc
3/16/2012 Effexor Venlafaxine Hydrochloride Pfizer Anchen Pharms
3/19/2012 Boniva Ibandronate Sodium Hoffman LA Roche Apotex
3/19/2012 Boniva Ibandronate Sodium Hoffman LA Roche Mylan
3/19/2012 Boniva Ibandronate Sodium Hoffman LA Roche Orchid Healthcare
3/20/2012 Boniva Ibandronate Sodium Hoffman LA Roche Watson Labs Inc
3/20/2012 Zyprexa Olanzpine Lilly Pharmaforce
3/22/2012 Levaquin Levofloxacin Janssen MacLeods Pharms
3/23/2012 Neurontin Gabapentin Parke Davis Amneal Pharms
3/26/2012 Seroquel Quetiapine Fumarate Astrazeneca Sun Pharma Global
3/27/2012 Levophed Norepinephrine Bitartrate Hospira Sintetica
3/27/2012 Seroquel Quetiapine Fumarate Astrazeneca Dr. Reddys Labs
3/27/2012 Seroquel Quetiapine Fumarate Astrazeneca Teva
3/27/2012 Seroquel Quetiapine Fumarate Astrazeneca Roxane
3/27/2012 Seroquel Quetiapine Fumarate Astrazeneca Mylan
3/27/2012 Seroquel Quetiapine Fumarate Astrazeneca Roxane
3/27/2012 Seroquel Quetiapine Fumarate Astrazeneca Apotex
3/27/2012 Modicon 28 Wera Janssen Novast Labs Ltd
3/27/2012 Seroquel Quetiapine Fumarate Astrazeneca Aurobindo Pharma
3/27/2012 Seroquel Quetiapine Fumarate Astrazeneca Torrent Pharms
3/27/2012 Seroquel Quetiapine Fumarate Astrazeneca Lupin
3/27/2012 Seroquel Quetiapine Fumarate Astrazeneca Accord Healthcare Inc
3/28/2012 Levonorgestrel and Ethinyl Estradiol Falmina Watson Labs Novast Labs Ltd
3/28/2012 Lo/Ovral-28 Elinest Wyeth Pharms Inc Novast Labs Ltd
3/29/2012 Methotrexate Sodium Preservative Free Methotrexate Sodium Preservative Free Bedford Onco Therapies Ltd.
3/29/2012 Methotrexate Sodium Preservative Free Methotrexate Sodium Preservative Free Bioniche Pharma USA Onco Therapies Ltd.
3/30/2012 Levaquin Levofloxacin Janssen Pharms Cipla Ltd.
3/30/2012 Avapro Irbesartan Sanofi Aventis US Teva
3/30/2012 Avalide Hydrochlorothiazide; Irbestartan Sanofi Aventis Teva
3/30/2012 Oxacillin Sodium Oxacillin Sodium Sandoz Sagent Pharms
3/30/2012 Oxacillin Sodium Oxacillin Sodium Sandoz Sagent Pharms
3/30/2012 Ultracet Acetaminophen; Tramadol Hydrochloride Janssen Pharms Alvogen Inc

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