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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 076633


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NDA 076633 describes FLUTICASONE PROPIONATE, which is a drug marketed by Cosette, Encube, Fougera Pharms, Nesher Pharms, Padagis Israel, Glenmark Generics, Bright, Taro Pharm Inds, Apotex, Apotex Inc, Chartwell Rx, Hikma, and Teva Pharms Usa, and is included in twenty-one NDAs. It is available from seventy-three suppliers. Additional details are available on the FLUTICASONE PROPIONATE profile page.

The generic ingredient in FLUTICASONE PROPIONATE is fluticasone propionate; salmeterol xinafoate. There are twenty-nine drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the fluticasone propionate; salmeterol xinafoate profile page.
Summary for 076633
Tradename:FLUTICASONE PROPIONATE
Applicant:Encube
Ingredient:fluticasone propionate
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CREAM;TOPICALStrength0.05%
Approval Date:May 14, 2004TE:RLD:No

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