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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 215343


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NDA 215343 describes FLUTICASONE PROPIONATE, which is a drug marketed by Cosette, Encube, Fougera Pharms, Nesher Pharms, Padagis Israel, Glenmark Pharms Ltd, Bright, Taro Pharm Inds, Apotex, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Rx, Hikma, and Teva Pharms Usa, and is included in twenty-two NDAs. It is available from seventy-one 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 215343
Tradename:FLUTICASONE PROPIONATE
Applicant:Bright
Ingredient:fluticasone propionate
Patents:0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:OINTMENT;TOPICALStrength0.005%
Approval Date:Sep 1, 2023TE:RLD:No

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