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ANDA Approvals
Summer 2013
Approval Date | Reference Listed Drug | Generic Drug Name | NDA Holder | ANDA Applicant |
---|---|---|---|---|
4/2/2013 | Zithromax | Azithromycin | Pfizer | Sun Pharm Indus |
4/3/2013 | Ampicillin Sodium | Ampicillin Sodium | Sandoz | ACS Dobfar Spa |
4/3/2013 | Ampicillin Sodium | Ampicillin Sodium | Sandoz | ACS Dobfar Spa |
4/3/2013 | Lunesta | Eszopiclone | Sunovion Pharms Inc | Sun Pharma Global |
4/3/2013 | Zovirax | Acyclovir | Valeant Int'l | Mylan Pharms |
4/4/2013 | Soriatane | Acitretin | Stiefel Labs | Barr Labs |
4/4/2013 | Gastrocrom | Cromolyn Sodium | Meda Pharms | Micro Labs |
4/4/2013 | Soriatane | Acitretin | Stiefel Labs | Barr Labs |
4/4/2013 | Cleocin Phosphate in 5% Dextrose in Plastic Container | Clindamycin Phosphate in 5% Dextrose in Plastic Container | Pharmacia and Upjohn | Akorn |
4/5/2013 | Lipitor | Atorvastatin Calcium | Pfizer | Kudco Ireland |
4/5/2013 | Reclast | Zoledronic Acid | Novartis | Hospira |
4/8/2013 | Risperdal | Risperidone | Janssen Pharms | Sun Pharm Indus |
4/10/2013 | Seasonique | Daysee | Teva Branded Pharm | Lupin |
4/10/2013 | Orapred ODT | Prednisolone Sodium Phosphate | Shionogi | Mylan Pharms |
4/12/2013 | Percocet | Oxycodone / Acetaminophen | Vintage Pharms | Actavis Elizabeth |
4/15/2013 | Acetaminophen and Codeine Phosphate; Tylenol w/Codeine No. 3; Acetaminophen and Codeine Phosphate | Acetaminophen / Codeine Phosphate | Mallinckrodt; Janssen Pharms; Teva | Aurolife Pharma |
4/16/2013 | Actoplus Met | Pioglitazone Hydrochloride / Metformin Hydrochloride | Takeda Pharms USA | Sandoz |
4/19/2013 | Zegerid | Omeprazole / Sodium Bicarbonate | Santarus | Par Pharm |
4/19/2013 | Reglan | Metoclopramide Hydrochloride | Baxter Healthcare | BD RX |
4/19/2013 | Diovan HCT | Valsartan / Hydrochlorothiazide | Novartis | MacLeods Pharms |
4/23/2013 | Luvox CR | Fluvoxamine Maleate | Jazz Pharms | Actavis Elizabeth |
4/23/2013 | Imitrex | Sumatriptan Succinate | GlaxoSmithKline | Aurobindo Pharma |
4/24/2013 | Promethazine Hydrochloride and Codeine Phosphate | Promethazine Hydrochloride / Codeine Phosphate | Actavis Mid Atlantic | Amneal Pharms |
4/24/2013 | Ortho-Novum 7/7/7-28 | Primella 7/7/7 | Janssen Pharms | Lupin |
4/24/2013 | Ortho-Novum 1/35-28 | Primella 1/35 | Janssen Pharms | Lupin |
4/25/2013 | Duricef | Cefadroxil | Warner Chilcott | Aurobindo Pharma |
4/25/2013 | Opana | Oxymorphone Hydrochloride | Endo Pharms | Mallinckrodt Inc |
4/25/2013 | Procardia | Nifedipine | Pfizer | Emcure Pharms USA |
4/26/2013 | Xopenex | Levalbuterol Hydrochloride | Sunovion | Teva Pharms USA |
4/29/2013 | Adderall XR 30 | Amphetamine / Dextroamphetamine | Shire | Teva Pharms USA |
4/29/2013 | Lopressor | Metoprolol Tartrate | Novartis | Claris LifeSciences |
4/29/2013 | Norvasc | Amlodipine Besylate | Pfizer | Accord Healthcare |
4/29/2013 | Ocuflox | Ofloxacin | Allergan | Altaire Pharms |
4/29/2013 | Accupril | Quinapril Hydrochloride | Pfizer Pharms | Aurobindo Pharma |
4/30/2013 | Doryx | Doxycycline Hyclate | Mayne Pharma | Heritage Pharms |
4/30/2013 | Cleocin | Clindamycin Palmitate Hydrochloride | Pharmacia and Upjohn | Aurobindo Pharma |
4/30/2013 | Flomax | Tamsulosin Hydrochloride | Boehringer Ingelheim | Aurobindo Pharma |
5/3/2013 | Atacand | Candesartan Cilexetil | AstraZeneca | Sandoz |
5/3/2013 | Hydralazine Hydrochloride | Hydralazine Hydrochloride | Pliva | Strides Arcolab |
5/6/2013 | Zyloprim | Allopurinol | Prometheus Labs | Accord Healthcare |
5/7/2013 | Gemzar | Gemcitabine Hydrochloride | Eli Lilly | Sagent Pharms |
5/7/2013 | Gemzar | Gemcitabine Hydrochloride | Eli Lilly | Pharmaforce |
5/7/2013 | Gemzar | Gemcitabine Hydrochloride | Eli Lilly | Jiangsu Hansoh Pharm |
5/7/2013 | Zometa | Zoledronic Acid | Novartis | Pharms |
5/7/2013 | Gemcitabine Hydrochloride | Gemcitabine Hydrochloride | Hospira | Dr Reddy's Labs |
5/8/2013 | Triaminolone Acetonide | Triamcinolone Acetonide | Morton Grove / Wockhardt | Versapharm |
5/9/2013 | Arthrotec | Diclofenac Sodium / Misoprostol | GD Searle | Sandoz |
5/10/2013 | Hydrocodone Bitartrate and Acetaminophen | Hydrocodone Bitartrate / Acetaminophen | Mikart | PAI |
5/13/2013 | Minocycline Hydrochloride | Minocycline Hydrochloride | Teva | Caraco |
5/13/2013 | Comtan | Entacapone | Orion Pharma | Mylan Pharms |
5/14/2013 | Zomig | Zolmitriptan | IPR | Glenmark Generics |
5/14/2013 | Zomig | Zolmitriptan | IPR | Apotex |
5/14/2013 | Zomig-ZMT | Zolmitriptan | AstraZeneca | Apotex |
5/14/2013 | Zomig | Zolmitriptan | AstraZeneca | Glenmark Generics |
5/14/2013 | Zomig | Zolmitriptan | IPR | Mylan Pharms |
5/15/2013 | Zomig-ZMT | Zolmitriptan | AstraZeneca | Zydus Pharms USA |
5/16/2013 | Exelon | Rivastigmine Tartrate | Novartis | Apotex |
5/16/2013 | Ultram | Tramadol Hydrochloride | Janssen Pharms | Accord Healthcare |
5/16/2013 | Femara | Letrozole | Novartis | Jiangsu Hengrui Med |
5/21/2013 | Imitrex | Sumatriptan Succinate | GlaxoSmithKline | Hikma Pharms |
5/24/2013 | Rocaltrol | Calcitriol | Validus Pharms | Banner Pharmacaps |
5/24/2013 | Sanctura XR | Trospium Chloride | Allergan | Paddock |
5/28/2013 | Plavix | Clopidogrel Bisulfate | Sanofi Aventis US | Actavis Totowa |
5/28/2013 | Vicoprofen | Hydrocodone Bitartrate / Ibuprofen | Abbvie | Sun Pharm Indus |
5/28/2013 | Vfend | Voriconazole | Pfizer | Mylan Pharms |
5/28/2013 | Metoprolol Tartrate | Metoprolol Tartrate | Mylan | Alembic Pharms |
5/29/2013 | Dextroamphetamine Sulfate | Dextroamphetamine Sulfate | Outlook Pharms | Tris Pharma |
5/30/2013 | Avodart | Dutasteride | GlaxoSmithKline | Banner Pharmacaps |
6/3/2013 | Vistaril | Hydroxyzine Pamoate | Pfizer | Emcure Pharms USA |
6/3/2013 | Depo-Testosterone | Testosterone Cypionate | Pharmacia and Upjohn | Sun Pharm Indus |
6/3/2013 | Kadian | Morphine Sulfate | Watson Labs | Upsher Smith |
6/3/2013 | Zometa | Zoledronic Acid | Novartis | Hikma Farmaceutica |
6/3/2013 | Atacand HCT | Candesartan Cilexetil / Hydrochlorothiazide | AstraZeneca | Apotex |
6/3/2013 | Atacand HCT | Candesartan Cilexetil / Hydrochlorothiazide | AstraZeneca | Dr Reddy's Labs |
6/5/2013 | Levaquin | Levofloxacin | Janssen Pharms | Claris LifeSciences |
6/10/2013 | Biaxin | Clarithromycin | Abbvie | Allied Pharma |
6/12/2013 | Lexapro | Escitalopram Oxalate | Forest Labs | Silarx Pharms |
6/12/2013 | Micronor | Norethindrone | Janssen Pharms | Famy Care |
6/13/2013 | Cellcept | Mycophenolate Mofetil | Roche Palo | Alkem Labs |
6/13/2013 | Catapres | Clonidine Hydrochloride | Boehringer Ingelheim | Carlsbad |
6/14/2013 | Lamictal | Lamotrigine | GlaxoSmithKline | Alkem Labs |
6/14/2013 | Cyklokapron | Tranexamic Acid | Pharmacia and Upjohn | Custopharm |
6/17/2013 | Lamictal XR | Lamotrigine | GlaxoSmithKline | Handa Pharms |
6/18/2013 | Rilutek | Riluzole | Covis Pharma | Apotex |
6/18/2013 | Rilutek | Riluzole | Covis Pharma | Glenmark Generics |
6/18/2013 | Rilutek | Riluzole | Covis Pharma | Sun Pharm Indus |
6/19/2013 | Levaquin in Dextrose 5% in Plastic Container | Levofloxacin in Dextrose 5% in Plastic Container | Janssen Pharms | Fresenius Kabi USA |
6/19/2013 | Lamictal XR | Lamotrigine | GlaxoSmithKline | Dr Reddy's Labs |
6/21/2013 | Carbatrol | Carbamazepine | Shire | Taro |
6/21/2013 | Skelaxin | Metaxalone | King Pharms | Amneal Pharms |
6/26/2013 | Keppra | Levetiracetam | UCB | Sagent Pharms |
6/26/2013 | Hycamtin | Topotecan Hydrochloride | GlaxoSmithKline | Accord Healthcare |
6/27/2013 | Coumadin | Warfarin Sodium | Bristol-Myers Squibb | IPCA Labs |
6/27/2013 | Fludeoxyglucose F18 | Fludeoxyglucose F18 | Weill Medical College | UCLA Biomedical |
6/27/2013 | Ammonia N 13 | Ammonia N 13 | Feinstein | UCLA Biomedical |
6/28/2013 | Tofranil-PM | Imipramine Pamoate | Mallinckrodt | Mylan Pharms |
6/28/2013 | FLUORINE F-18 | Sodium Fluoride F-18 | GE Healthcare | MCPRF |
GENERICally Speaking Summer 2013
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