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20121S009_Flonase.htm Food and Drug Administration • Center for Drug Evaluation and Research Approval Package Search Flonase (Fluticasone Propionate) Nasal Spray Company:--GlaxoWellcome, Inc
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Microsoft Word - N20121S28AP.doc 6 7 DESCRIPTION 8 Fluticasone propionate, the active component of FLONASE Nasal Spray, is a synthetic 9 corticosteroid having the chemical name S-( fluoromethyl) 6 , 9- difluoro- 11 - 17- dihydroxy- 16 - 10 methyl- 3- oxoandrosta- 1,4- diene- 17 - carbothioate, 17- propionate and the following chemical 11 structure: 12 13 14 15 Fluticasone propionate is a white to...
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http://www.fda.gov/cder/ogd/rld/RLD_LABELING_APPROVED_OCT_1998.HTML Firm Date FLONASE Fluticasone propionate nasal spray 20-121 S-010 Glaxo Wellcome 1-Oct-1998 EMCYT Estramustine phosphate sodium capsules 18-045 S-010 Pharmacia and Upjohn 9-Oct-1998 COZAAR Losartan potassium tablets 20-386 S-008 Merck 13-Oct-1998 VASERETIC Enalapril maleate and HCTZ tablets 19-221 S-024 Merck 13-Oct-1998 TIMOLIDE Timolol maleate and HCTZ tablets 18-061 S...
Microsoft Word - 02-12-13 N20-548 SE8-018 Flovent BPCA.doc BPCA CLINICAL SUMMARY OF NDA 20- 548, SE8- 018 APPLICATIONS: NDA 20- 548, SE8- 018 TRADE NAME: Flovent® Inhalation Aerosol APPLICANT: GlaxoSmithKline Research Triangle Park, North Carolina 27709 USAN NAME: Fluticasone propionate inhalation aerosol (CFC MDI) MEDICAL OFFICER: Peter Starke, MD CATEGORY: Corticosteroid TEAM LEADER: Eugene Sullivan, MD ROUTE: Oral inhalation...
