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Last Updated: December 14, 2025

Details for New Drug Application (NDA): 077287

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NDA 077287 describes PREDNICARBATE, which is a drug marketed by Fougera Pharms and is included in two NDAs. Additional details are available on the PREDNICARBATE profile page.

The generic ingredient in PREDNICARBATE is prednicarbate. There are four drug master file entries for this compound. Additional details are available on the prednicarbate profile page.

Summary for 077287

Tradename:	PREDNICARBATE
Applicant:	Fougera Pharms
Ingredient:	prednicarbate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CREAM;TOPICAL			Strength	0.1%
Approval Date:	Sep 19, 2006	TE:		RLD:	No

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