Last Updated: November 8, 2026

Details for New Drug Application (NDA): 074905

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NDA 074905 describes FLUOCINONIDE, which is a drug marketed by Amneal, Cosette Pharms Nc, Encube, Fougera Pharms Inc, Glenmark Pharms Ltd, Padagis Israel, Perrigo New York, Sun Pharma Canada, Teva, Zydus Lifesciences, Alvogen, Padagis Us, Chartwell Rx, Fougera Pharms, Pai Holdings Pharm, Xiromed, Encube Ethicals, Macleods Pharms, Novel Labs Inc, Quagen, Sciegen Pharms, Teva Pharms, Zydus Pharms, and Taro, and is included in forty-five NDAs. It is available from twenty-four suppliers. Additional details are available on the FLUOCINONIDE profile page.

The generic ingredient in FLUOCINONIDE is fluocinolone acetonide. There are two drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.

Summary for 074905

Tradename:	FLUOCINONIDE
Applicant:	Fougera Pharms
Ingredient:	fluocinonide
Patents:	0

Medical Subject Heading (MeSH) Categories for 074905

Anti-Allergic Agents
Anti-Inflammatory Agents
Glucocorticoids

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	OINTMENT;TOPICAL			Strength	0.05%
Approval Date:	Aug 26, 1997	TE:	AB	RLD:	No

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