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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 207554

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NDA 207554 describes FLUOCINONIDE, which is a drug marketed by Amneal, Cosette, Encube, Fougera Pharms Inc, Glenmark Pharms Ltd, Padagis Israel, Pai Holdings Pharm, Perrigo New York, Taro, Teva, Zydus Lifesciences, Alvogen, Padagis Us, Chartwell Rx, Fougera Pharms, Xiromed, Encube Ethicals, Macleods Pharms Ltd, Novel Labs Inc, Teva Pharms, and Zydus Pharms, and is included in forty-four NDAs. It is available from twenty-eight suppliers. Additional details are available on the FLUOCINONIDE profile page.

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

Summary for 207554

Tradename:	FLUOCINONIDE
Applicant:	Pai Holdings Pharm
Ingredient:	fluocinonide
Patents:	0

Medical Subject Heading (MeSH) Categories for 207554

Anti-Allergic Agents
Anti-Inflammatory Agents
Glucocorticoids

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;TOPICAL			Strength	0.05%
Approval Date:	Mar 18, 2019	TE:		RLD:	No

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