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ANDA Approvals

Approval Date Reference Listed Drug Generic Drug Name NDA Holder ANDA Applicant
4/1/2015 Femcon FE Norethindrone / Ethinyl Estradiol / Ferrous Fumarate Warner Chilcott Famy Care
4/1/2015 Revatio Sildenafil Citrate Pfizer Aurobindo Pharma
4/3/2015 Exforge Amlodipine Besylate / Valsartan Novartis Alembic Pharms
4/6/2015 Exalgo Hydromorphone Hydrochloride Mallinckrodt Paddock
4/6/2015 MS Contin Morphine Sulfate Purdue Pharma Actavis Elizabeth
4/7/2015 Fludeoxyglucose F18 Fludeoxyglucose F18 Feinstein Precision Nuclear
4/7/2015 Tri-Estarylla Norgestimate / Ethinyl Estradiol Sandoz OC Pharma
4/7/2015 Ortho Cyclen-28 Norgestimate / Ethinyl Estradiol Janssen Pharms OC Pharma
4/8/2015 Atracurium Besylate Atracurium Besylate Eurohealth International Aurobindo Pharma
4/8/2015 Atracurium Besylate Preservative Free Atracurium Besylate Preservative Free Eurohealth International Aurobindo Pharma
4/8/2015 Valtrex Valacyclovir Hydrochloride GlaxoSmithKline Hetero Labs
4/9/2015 Levonorgestrel / Ethinyl Estradiol Levonorgestrel / Ethinyl Estradiol Watson Labs Glenmark Generics
4/10/2015 Namenda Memantine Hydrochloride Forest Labs Amneal Pharms
4/10/2015 Namenda Memantine Hydrochloride Forest Labs Lupin Ltd
4/10/2015 Norethindrone Acetate / Ethinyl Estradiol Norethindrone Acetate / Ethinyl Estradiol Barr Labs Glenmark Generics
4/13/2015 Nulytely PEG-3350 / Potassium Chloride / Sodium Bicarbonate / Sodium Chloride Braintree Labs Strides Arcolab
4/13/2015 Kenalog Triamcinolone Acetonide Ranbaxy Perrigo UK Finco
4/14/2015 Benztropine Mesylate Benztropine Mesylate USL Pharma Nuvo Pharm
4/14/2015 Suprax Cefixime Lupin Pharms Aurobindo Pharma
4/15/2015 Xanax Alprazolam Pharmacia and Upjohn Natco Pharma
4/16/2015 Copaxone Glatiramer Acetate Teva Pharms USA Sandoz
4/17/2015 Istalol Timolol Maleate Bausch and Lomb Apotex
4/20/2015 Topicort Desoximetasone Taro Perrigo New York
4/20/2015 Carac Fluorouracil Valeant Pharms North Spear Pharms
4/20/2015 Sodium Fluoride F-18 Sodium Fluoride F-18 Houston Cyclotron Univ Utah Cylcotron
4/21/2015 Seasonale Levonorgestrel / Ethinyl Estradiol Teva Branded Pharm Famy Care
4/22/2015 Ammonia N 13 Ammonia N 13 Feinstein IBA Molecular North America
4/22/2015 Fludeoxyglucose F18 Fludeoxyglucose F18 Feinstein Spectron MRC
4/22/2015 Sodium Fluoride F-18 Sodium Fluoride F-18 Houston Cyclotron Spectron MRC
4/22/2015 Staxyn Vardenafil Hydrochloride Bayer Healthcare Watson Labs
4/23/2015 Ammonia N 13 Ammonia N 13 Feinstein Spectron MRC
4/23/2015 Xeloda Capecitabine Hoffmann La Roche Accord Healthcare
4/23/2015 Fludeoxyglucose F18 Fludeoxyglucose F18 Feinstein Methodist Hospital Research
4/23/2015 Zometa Zoledronic Acid Novartis Fresenius Kabi USA
4/24/2015 Opana ER Oxymorphone Hydrochloride Endo Pharms Sun Pharm Inds
4/24/2015 Qualaquin Quinine Sulfate Mutual Pharm Lupin
4/24/2015 Prandin Repaglinide Novo Nordisk Standard Chem Pharm
4/28/2015 Abilify Aripiprazole Otsuka Teva Pharms USA
4/28/2015 Abilify Aripiprazole Otsuka Teva Pharms USA
4/28/2015 Abilify Aripiprazole Otsuka Teva Pharms USA
4/28/2015 Abilify Aripiprazole Otsuka Torrent Pharms
4/28/2015 Abilify Aripiprazole Otsuka Alembic Pharms
4/28/2015 Abilify Aripiprazole Otsuka Alembic Pharms
4/28/2015 Abilify Aripiprazole Otsuka Hetero Labs
4/29/2015 Zyprexa Olanzapine Lilly Ivax Pharms Inc
4/29/2015 Oxycodone Hydrochloride Oxycodone Hydrochloride Lehigh Valley Novel Labs Inc
4/29/2015 Sanctura XR Trospium Chloride Allergan Sandoz Inc
4/30/2015 Kariva Kimidess Barr Vintage Pharms
5/1/2015 Ammonia N 13 Ammonia N 13 Feinstein Biomedical Research Foundation
5/1/2015 Fludeoxyglucose F 18 Fludeoxyglucose F 18 Downstate Clinical Biomedical Research Foundation
5/1/2015 Fludeoxyglucose F 18 Fludeoxyglucose F 18 Downstate Clinical Biomedical Research Foundation
5/4/2015 Lotronex Alosetron Hydrochloride Prometheus Labs Roxane
5/4/2015 Yasmin Drospirenone / Ethinyl Estradiol Bayer Healthcare Famy Care
5/5/2015 Bimatoprost Bimatoprost Lupin Alcon Research
5/7/2015 Hectorol Doxercalciferol Genzyme Corp Akorn
5/8/2015 Temodar Temozolomide Merck Sharp Dohme Amneal Pharms
5/11/2015 Ovcon-35 Norethindrone / Ethinyl Estradiol Warner Chilcott Famy Care
5/12/2015 Morphine Sulfate Morphine Sulfate Roxane Tris Pharma
5/13/2015 Combivir Lamivudine and Zidovudine VIIV Healthcare Strides Arcolab
5/14/2015 Lexapro Escitalopram Oxalate Forest Labs Mylan Pharms
5/15/2015 Zithromax Azithromycin Pfizer Lupin
5/15/2015 Kapvay Clonidine Hydrochloride  Concordia Pharms Actavis Elizabeth
5/18/2015 Zyvox Linezolid Pharmacia and Upjohn Teva Pharms USA
5/18/2015 Atelvia Risedronate Sodium Warner Chilcott Teva Pharms USA
5/19/2015 Glucotrol XL Glipizide Pfizer Mylan Pharms
5/20/2015 Ortho-Cept Desogestrel / Ethinyl Estradiol Janssen Pharms Famy Care
5/21/2015 Casodex Bicalutamide AstraZeneca Apotex
5/21/2015 Felodipine Felodipine Mylan Orchid Healthcare
5/21/2015 Keppra XR Levetiracetam UCB Prinston Inc
5/21/2015 Methotrexate Sodium Methotrexate Sodium Dava Pharms Orion Corp Orion
5/21/2015 Morphine Sulfate Morphine Sulfate Hospira Eurohealth International
5/21/2015 Vienva Levonorgestrel / Ethinyl Estradiol Watson Labs Sandoz
5/22/2015 Soriatane Acitretin Stiefel Labs Sigmapharm Labs
5/22/2015 Magnesium Sulfate Magnesium Sulfate Fresenius Kabi USA Hospira
5/22/2015 Singulair Montelukast Sodium Merck Hetero Labs
5/26/2015 Wellbutrin SR Bupropion Hydrochloride GlaxoSmithKline Prinston
5/26/2015 Lexapro Escitalopram Oxalate Forest Labs Antrim Pharms
5/27/2015 Mucinex D Guaifenesin / Pseudoephedrine Hydrochloride (OTC) Reckitt Benckiser Actavis Labs FL
5/27/2015 Seasonique Levonorgestrel / Ethinyl Estradiol Teva Branded Pharm Famy Care
5/27/2015 Tygacil Tigecycline PF Prism CV Sandoz
5/28/2015 DDAVP Desmopressin Acetate Ferring Pharms Glenmark Pharms
5/28/2015 Monodox Doxycycline Aqua Pharms Novel Labs Inc
5/28/2015 Moxeza Moxifloxacin Hydrochloride Alcon Pharms Lupin
5/28/2015 Venlafaxine Hydrochloride Venlafaxine Hydrochloride Teva Yaopharma
5/29/2015 Diuril Chlorothiazide Sodium Oak Pharms Akorn Sagent Pharms
5/29/2015 Cleocin T Clindamycin Phosphate Pharmacia and Upjohn Vintage Pharms
5/29/2015 Coly-Mycin M Colistimethate Sodium Par Sterile Products Xellia Pharms APS
5/29/2015 Depakote ER Divalproex Sodium AbbVie Amneal Pharms
5/29/2015 Plan B One-Step Levonorgestrel (OTC) Teva Branded Pharm OC Pharma
5/29/2015 Flagyl Metronidazole GE Searle Aurobindo Pharma
6/1/2015 Exforge HCT Amlodipine Besylate / Valsartan / Hydrochlorothiazide Novartis Par Pharm
6/1/2015 Oxycodone Hydrochloride Oxycodone Hydrochloride Vistapharm Ani Pharms
6/2/2015 Celebrex Celecoxib GD Searle Apotex
6/2/2015 Intuniv Guanfacine Hydrochloride Shire Teva Pharms USA
6/2/2015 Intuniv Guanfacine Hydrochloride Shire TWI Pharms
6/2/2015 Intuniv Guanfacine Hydrochloride Shire Mylan Pharms
6/3/2015 Exforge HCT Amlodipine Besylate / Valsartan / Hydrochlorothiazide Novartis Lupin
6/3/2015 Intuniv Guanfacine Hydrochloride Shire Sandoz
6/3/2015 Zyvox Linezolid Pharmacia and Upjohn Roxane
6/3/2015 Intermezzo Zolpidem Tartrate Purdue Pharma Novel Labs
6/4/2015 Exforge HCT Amlodipine Besylate / Valsartan / Hydrochlorothiazide Novartis Torrent Pharms
6/4/2015 Keppra Levetiracetam UCB Pharm Assoc
6/4/2015 Lincocin Lincomycin Pharmacia and Upjohn X-Gen Pharms Inc
6/4/2015 Restoril Temazepam Mallinckrodt Vintage Pharms
6/5/2015 Aricept Donepezil Hydrochloride Eisai Sun Pharm Inds
6/5/2015 Integrilin Eptifibatide Schering Teva Pharms USA
6/5/2015 Plan B One-Step Levonorgestrel (OTC) Teva Branded Pharm Lotus Pharm
6/9/2015 Dovonex Calcipotriene Leo Pharma Glenmark Pharms
6/9/2015 Celebrex Celecoxib GD Searle Lupin
6/9/2015 Oxsoralen-Ultra Methoxsalen Dow Pharm Actavis
6/9/2015 Metadate ER Methylphenidate Hydrochloride UCB Abhai
6/9/2015 Diovan Valsartan Novartis Prinston
6/10/2015 Casodex Bicalutamide AstraZeneca Stason Pharms
6/10/2015 Buprenorphine Hydrochloride Buprenorphine Hydrochloride Roxane Sandoz
6/10/2015 Lithobid Lithium Carbonate Ani Pharms Alembic Pharms
6/10/2015 Dilantin Phenytoin Sodium Parke Davis Aurobindo Pharma
6/10/2015 Exelon Rivastigmine Tartrate Novartis Orchid Healthcare
6/12/2015 Ziana Clindamycin Phosphate / Tretinoin Medicis Actavis Mid Atlantic
6/12/2015 Topicort Desoximetasone Taro Versapharm
6/12/2015 Integrilin Eptifibatide Schering Teva Pharms USA
6/12/2015 Seasonale Levonorgestrel / Ethinyl Estradiol Teva Branded Pharm Glenmark Pharms
6/15/2015 Factive Gemifloxacin Mesylate LG Life Sciences Orchid Healthcare
6/16/2015 Oxycodone Hydrochloride Oxycodone Hydrochloride Vistapharm Wockhardt Bio
6/17/2015 Loseasonique Levonorgestrel / Ethinyl Estradiol  Teva Branded Pharm Famy Care
6/18/2015 Macrodantin Nitrofurantoin Alvogen Actavis Labs FL
6/19/2015 Acetadote Acetylcysteine Cumberland Pharms Mylan Institutional
6/19/2015 Zithromax Azithromycin Pfizer Aurobindo Pharma
6/19/2015 Acanya Clindamycin Phosphate / Benzoyl Peroxide Dow Pharm Actavis Labs UT
6/19/2015 Cyclobenzaprine Hydrochloride Cyclobenzaprine Hydrochloride Mylan Pharms Orit Labs
6/19/2015 Comtan Entacapone Orion Pharma Aurobindo Pharma
6/19/2015 Levaquin Levofloxacin Janssen Pharms Jubilant Generics
6/22/2015 Mestinon Pyridostigmine Bromide Valeant Pharms Zydus Pharms USA
6/23/2015 Ammonia N 13 Ammonia N 13 Feinstein Central Radiopharm
6/23/2015 Fludeoxyglucose F 18 Fludeoxyglucose F 18 Downstate Clinical Triad Isotopes
6/23/2015 Fludeoxyglucose F 18 Fludeoxyglucose F 18 Downstate Clinical Univ Utah Cyclotron
6/25/2015 Derma-Smoothe/FS Fluocinolone Acetonide Hill Dermac Versapharm
6/26/2015 Zetia Ezetimibe MSD International Glenmark Pharms
6/26/2015 Xyzal Levocetirizine Dihydrochloride UCB Sun Pharm Inds
6/26/2015 Mestinon Pyridostigmine Bromide Valeant Pharms Alvogen
6/29/2015 Phoslo Gelcaps Calcium Acetate Fresenius Medical Zydus Pharms USA
6/29/2015 Pristiq Desvenlafaxine Succinate Wyeth Pharms Alembic Pharms
6/29/2015 Pristiq Desvenlafaxine Succinate Wyeth Pharms Sandoz
6/29/2015 Pristiq Desvenlafaxine Succinate Wyeth Pharms Mylan Pharms
6/29/2015 Pristiq Desvenlafaxine Succinate Wyeth Pharms Lupin
6/29/2015 Hydralazine Hydrochloride Hydralazine Hydrochloride Akorn X-Gen Pharms
6/29/2015 Ortho Tricylen Lo Norgestimate / Ethinyl Estradiol Janssen Pharms Sandoz

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