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Search results for: bendroflumethiazide
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CDER News Archive April 2007
... , 2007 New and Generic Drug Approvals Avandaryl (rosiglitazone maleate and glimepiride) Tablets, SB Pharmco, Manufacturing Change or Addition Benzonatate Capsules, The Pharma Network, Approval Benzphetamine Hydrochloride Tablets, Tedor Pharma, Approval Carboplatin Injection, Sicor Pharma, Approval Cordarone (amiodarone HCl) Tablets, Wyeth Pharma, Labeling Revision Galantamine Hydrobromide Tablets, Watson Labs, Tentative Approval Hydrocortisone Tablets, Stiefel Labs, Approval Isosorbide Dinitrate Tablets, West-Ward Pharma, Control Supplement Janumet (sitagliptin / metformin hydrochloride) Tablets, Merck & Co, Approval Nadolol / Bendroflumethiazide Tablets, Impax Labs, Approval April 2, 2007 FDA approves first-time generic nadolol / endroflumethiazide tablets to treat hypertension. The reference listed drug is Corzide. New and Generic Drug Approvals Albuterol Sulfate and Ipratropium Bromide Inhalation Solution, Apotex, Tentative Approval Ambien (zolpidem tartrate) Tablets, Sanofi-Aventis, Patient Population Altered Carnitor (levocarnitine) Tablets, Sigma-Tau Pharma, Labeling Revision Carnitor (levocarnitine) Oral Solution, Sigma-Tau Pharma, Formulation Revision Clindamycin Injection, Abraxis Pharma, Approval Meloxicam Tablets, Aurobindo Pharma, Labeling Naproxen Tablets, Glenmark Pharma ...
URL: http://www.betterchem.com/portlets/cder_news_archive/187.htm
CDER News Archive February 2008
... , 2008 CDER Key Officials Drug Shortages Drugs @FDA Downloadable Data Files (updated) Drug Shortages PDF] Annex I: Residue on Ignition / Sulphated Ash General Chapter [PDF] Pediatric Exclusivity Statistics: Pediatric Exclusivity Labeling Changes (updated) February 19, 2008 CDER Key Officials February 18, 2008 New and Generic Drug Approvals Cefuroxime Axetil Tablets, Orchid Healthcare, Approval Cetirizine Hydrochloride Chewable Tablets, Sandoz Inc, Approval Lamotrigine Tablets, Sandoz Inc, Tentative Approval Metoprolol Succinate Extended Release Tablets, AstraZeneca, Control Supp. Nadolol and Bendroflumethiazide Tablets, Mylan Pharma, Approval SIMCOR (niacin extended-release / simvastatin) Tablets, Abbott Labs, Approval Tekturna (aliskiren) Tablets, Novartis Pharma, Labeling Revision February 15, 2008 Acronyms and Abbreviations Database Download File Approved Drug Products with Therapeutic Equivalence Evaluations: Orange Book New and Generic Drug Approvals Benztropine Mesylate Tablets, Actavis, Approval Emsam Patches (selegiline) Transdermal System, Somerset Pharma, Labeling Revision Granisetron Hydrochloride Tablets, Orchid Healthcare, Approval Halcion (triazolam) Tablets, Pharmacia & Upjohn, Labeling Revision Letairis (ambrisentan) Tablets ...
URL: http://www.betterchem.com/portlets/cder_news_archive/197.htm
First-Time Generics - March 2007
... 12.5 MG, 15 MG / 12.5 MG, AND 15 MG / 25 MG TEVA PHARMACEUTICALS, USA UNIRETIC TABLETS 3 / 7 / 2007 2 DIDANOSINE FOR ORAL SOLUTION (PEDIATRIC POWDER ), 10 MG / ML; 2 GRAM AND 4 GRAM CONTAINERS AUROBINDO PHARMA LIMITED VIDEX FOR ORAL SOLUTION 3 / 8 / 2007 3 PREDNICARBATE OINTMENT, 0.1 %ALTANA INC. DERMATOP OINTMENT 3 / 9 / 2007 4 CIPROFLOXACIN EXTENDED-RELEASE TABLETS, 500 MG AND 1000 MG MYLAN PHARMACEUTICALS INC. CIPRO XL TABLETS 3 / 22 / 2007 5 NADOLOL AND BENDROFLUMETHIAZIDE TABLETS USP, 40 MG / 5 MG AND 80 MG / 5 MG IMPAX LABORATORIES, INC. CORZIDE TABLETS 3 / 30 / 2007-- Links on this page: Page Last Updated: 04 / 30 / 2009 Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Home About FDA Contact Us A to Z Subject Index Site Map Web Site Policies Transparency FOIA Accessibility No FEAR Act Combination Products Advisory Committees Science & Research Regulatory Information Safety Emergency Preparedness International Programs News & ...
URL: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/DrugandBiologicApprovalReports/ANDAGenericDrugApprovals/UCM062081
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