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ANDA Approvals
Winter 2014
| 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 |
GENERICally Speaking Winter 2014
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