ANDA Approvals

Winter 2014

GENERICally Speaking
Approval Date Reference Listed Drug Generic Drug Name NDA Holder ANDA Applicant
10/2/2014 Adenoscan Adenosine Astellas Akorn
10/6/2014 PhosLo Gelcaps Calcium Acetate Fresenius Medical Amneal Pharms
10/8/2014 Patanase Olopatadine Hydrochloride Alcon Pharms Apotex
10/15/2014 Ritalin LA Methylphenidate Hydrochloride Novartis Barr Labs
10/21/2014 Fludeoxyglucose F18 Fludeoxyglucose F18 Feinstein Global Isotopes
10/21/2014 Sodium Fluoride F-18 Sodium Fluoride F-18 Houston Cyclotron Global Isotopes
10/23/2014 Ammonia N 13 Ammonia N 13 Feinstein Global Isotopes
10/24/2014 Astelin Azelastine Hydrochloride Meda Pharms Roxane
10/24/2014 Opana ER Oxymorphone Hydrochloride Extended-Release Endo Pharms Par Pharm
10/24/2014 Stromectol Ivermectin Merck Sharp Dohme Edenbridge Pharms
10/27/2014 Differin Adapalene Galderma Labs Actavis Mid Atlantic
10/27/2014 Rapamune Sirolimus PF Prism CV Dr Reddy's Labs
10/27/2014 Soma Carisoprodol Meda Pharms Orient Pharma
10/27/2014 Viramune XR Nevirapine Boehringer Ingelheim Mylan
10/28/2014 Soma Carisoprodol Meda Pharms Natco Pharma
10/28/2014 Metoprolol Tartrate Metoprolol Tartrate Mylan Rubicon Res PVT
10/28/2014 Seroquel Quetiapine Fumarate AstraZeneca Alembic Pharms
10/28/2014 Rezira Hydrocodone Bitartrate / Pseudoephedrine Hydrochloride Cypress Pharm Tris Pharma
10/28/2014 Mirapex Pramipexole Dihydrochloride Boehringer Ingelheim Sciegen Pharms
10/29/2014 Oxytocin / Oxytocin /Pitocin Oxytocin Fresenius Kabi USA / Hikma Maple / Par Sterile Products Sagent Pharms
10/29/2014 Femara Letrozole Novartis Pharms Lannett Holdings
10/29/2014 Celebrex Celecoxib GD Searle Lupin
10/29/2014 Isoniazid Isoniazid Sandoz ThePharmaNetwork
10/29/2014 Aricept Donepezil Hydrochloride Eisai TWI Pharms
10/29/2014 Aricept Donepezil Hydrochloride Eisai Sciegen Pharms
10/29/2014 Zosyn Piperacillin / Tazobactam Wyeth Sandoz
10/29/2014 Fludeoxyglucose F18 Fludeoxyglucose F18 Feinstein Trustees Univ PA
10/29/2014 Fludeoxyglucose F18 Fludeoxyglucose F18 Feinstein Children's Hospital MI
10/29/2014 Fludeoxyglucose F18 Fludeoxyglucose F18 Feinstein SPDC
10/29/2014 Sodium Fluoride F-18 Sodium Fluoride F18 Houston Cyclotron Essential Isotopes
10/30/2014 Myfortic Mycophenolic Acid Novartis Teva Pharms USA
10/30/2014 Loestrin 24 FE Norethindrone Acetate / Ethinyl Estradiol / Ferrous Fumarate Warner Chilcott Famy Care
10/30/2014 Singulair Montelukast Sodium Merck Unimark Remedies
10/30/2014 Singulair Montelukast Sodium Merck Unimark Remedies
10/30/2014 Ammonia N 13 Ammonia N 13 Feinstein Brigham Women's Hosp
10/30/2014 Fludeoxyglucose F18 Fludeoxyglucose F18 Feinstein Brigham Women's Hosp
10/30/2014 Fludeoxyglucose F18 Fludeoxyglucose F18 Feinstein Hot Shots NM
10/31/2014 Prilosec Omeprazole AstraZeneca Glenmark Generics
10/31/2014 Antara (Micronized) Fenofibrate Lupin Atlantis Ranbaxy Labs
10/31/2014 Desowen Desonide Galderma Labs Taro
10/31/2014 Luvox CR Fluvoxamine Maleate Jazz Pharms Torrent Pharms
10/31/2014 Epivir Lamivudine ViiV Healthcare Silarx Pharms
10/31/2014 Paxil Paroxetine Apotex Technologies Prinston
10/31/2014 Wellbutrin SR Bupropion Hydrochloride GlaxoSmithKline Torrent Pharms
10/31/2014 Cyclophosphamide / Cytoxan Cyclophosphamide Baxter Healthcare Jiangsu Hengrui Med
11/3/2014 Micardis Telmisartan Boehringer Ingelheim Sandoz
11/4/2014 Valcyte Valganciclovir Hydrochloride Hoffmann LA Roche Endo Pharms
11/4/2014 Valcyte Valganciclovir Hydrochloride Hoffmann LA Roche Dr Reddy's Labs
11/5/2014 Taxotere Docetaxel Sanofi Aventis US Dr Reddy's Labs
11/7/2014 Zoloft Sertraline Hydrochloride Pfizer Accord Healthcare
11/13/2014 Zomig Zolmitriptan IPR Sun Pharma Global
11/14/2014 Cellcept Mycophenolate Mofetil Roche Palo Alkem Labs
11/18/2014 Allegra-D 12 Fexofenadine Hydrochloride / Pseudoephedrine Hydrochloride Sanofi Aventis US Dr Reddy's Labs
11/18/2014 Brimonidine Tartrate Brimonidine Tartrate Bausch and Lomb Indoco Remedies
11/19/2014 Yasmin Drospirenone / Ethinyl Estradiol Bayer Healthcare Novast Labs
11/19/2014 Sodium Fluoride F-18 Sodium Fluoride F-18 Houston Cyclotron The Feinstein Inst
11/20/2014 Propecia Finasteride Merck Cipla
11/20/2014 Zomig Zolmitriptan IPR Jubilant Generics
11/20/2014 Ammonia N 13 Ammonia N 13 Feinstein MIPS CRF
11/24/2014 Zometa Zoledronic Acid Novartis Sagent Pharms
11/24/2014 Pennsaid Diclofenac Sodium Mallinckrodt Paddock
11/25/2014 Zocor Simvastatin Merck Hetero Labs
11/25/2014 Precedex Dexmedetomidine Hydrochloride Hospira Akorn
11/25/2014 Pennsaid Diclofenac Sodium Mallinckrodt Watson Labs
11/26/2014 Revatio Sildenafil Citrate Pfizer Hetero Labs
11/26/2014 Pennsaid Diclofenac Sodium Mallinckrodt Taro
11/26/2014 Zutripro Hydrocodone Bitartrate / Chlorpheniramine Maleate / Pseudoephedrine Hydrochloride Cypress Pharm Tris Pharma
11/26/2014 Synalgos-DC-A Acetaminophen / Caffeine / Dihydrocodeine Bitartrate Leitner Pharms Wraser Pharms
11/28/2014 Dilantin Phenytoin Pfizer Corepharma
11/28/2014 Kayexalate Sodium Polystyrene Sulfonate Covis Pharma Nuvo Pharm
11/28/2014 Sodium Fluoride F-18 Sodium Fluoride F-18 Houston Cyclotron NCM USA Bronx
12/1/2014 Latisse Bimatoprost Allergan Apotex
12/2/2014 Protonix Pantoprazole Sodium Wyeth Pharms Orchid Healthcare
12/4/2014 Mirapex Pramipexole Dihydrochloride Boehringer Ingelheim Sandoz
12/5/2014 Phentermine Hydrochloride Phentermine Hydrochloride Sandoz Ken Lifescience
12/8/2014 Nordette-28 Levonorgestrel / Ethinyl Estradiol Teva Branded Pharm Haupt Pharma
12/8/2014 Levonorgestrel / Ethinyl Estradiol Levonorgestrel / Ethinyl Estradiol Watson Labs Famy Care
12/12/2014 Rocaltrol Calcitriol Validus Pharms Strides Arcolab
12/12/2014 Taclonex Calcipotriene / Betamethasone Dipropionate Leo Pharma Perrigo Israel
12/15/2014 Cellcept Mycophenolate Mofetil Roche Palo Cadista Pharms
12/15/2014 Cellcept Mycophenolate Mofetil Roche Palo Cadista Pharms
12/15/2014 Opana Oxymorphone Hydrochloride Endo Pharms Corepharma
12/18/2014 Wellbutrin XL Bupropion Hydrochloride Valeant Sun Pharma Global
12/18/2014 Cosopt Dorzolamide Hydrochloride / Timolol Maleate Oak Pharms Lannett Holdings
12/18/2014 Roxicet Oxycodone Hydrochloride / Acetaminophen Roxane Vintage Pharms
12/18/2014 Fludeoxyglucose F18 Fludeoxyglucose F18 Feinstein Shertech Labs
12/18/2014 Ammonia N 13 Ammonia N 13 Feinstein WI Medical Cyclotron
12/18/2014 Epivir Lamivudine ViiV Healthcare Lupin
12/19/2014 Vivelle-Dot Estradiol Novartis Mylan Technologies
12/19/2014 Acetazolamide Sodium Acetazolamide Sodium X Gen Pharms Emcure Pharms
12/23/2014 Prometh VC w/Codeine Promethazine Hydrochloride / Phenylephrine Hydrochloride w/Codeine Phosphate Actavis Mid Atlantic Hi-Tech Pharma
12/23/2014 Pometh VC Plain Phenylephrine Hydrochloride / Promethazine Hydrochloride Actavis Mid Atlantic Hi-Tech Pharmacal
12/29/2014 Kadian Morphine Sulfate Watson Labs Teva Pharms USA

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