Last Updated: September 24, 2026

Details for New Drug Application (NDA): 209118

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NDA 209118 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-five 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. Nineteen suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.

Summary for 209118

Tradename:	FLUOCINONIDE
Applicant:	Chartwell Rx
Ingredient:	fluocinonide
Patents:	0

Medical Subject Heading (MeSH) Categories for 209118

Anti-Allergic Agents
Anti-Inflammatory Agents
Glucocorticoids

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;TOPICAL			Strength	0.05%
Approval Date:	Apr 23, 2018	TE:	AT	RLD:	No

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