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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 077145

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NDA 077145 describes FLUTICASONE PROPIONATE, which is a drug marketed by Cosette, Encube, Fougera Pharms, Nesher Pharms, Padagis Israel, Glenmark Pharms Ltd, Bright, Chartwell Rx, Taro Pharm Inds, Apotex, Aurobindo Pharma Ltd, Hikma, Rubicon, Rubicon Research, Respirent Pharms, and Teva Pharms Usa, and is included in twenty-five NDAs. It is available from sixty-nine 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 077145

Tradename:	FLUTICASONE PROPIONATE
Applicant:	Taro Pharm Inds
Ingredient:	fluticasone propionate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	OINTMENT;TOPICAL			Strength	0.005%
Approval Date:	Jun 14, 2005	TE:		RLD:	No

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