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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 216389

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NDA 216389 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, Sun Pharma Canada, Teva, Zydus Lifesciences, Alvogen, Padagis Us, Chartwell Rx, Fougera Pharms, Xiromed, Encube Ethicals, Macleods Pharms Ltd, Novel Labs Inc, Quagen, Sciegen Pharms Inc, Teva Pharms, Zydus Pharms, and Taro, and is included in forty-five NDAs. It is available from twenty-six 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-one suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.

Summary for 216389

Tradename:	FLUOCINONIDE
Applicant:	Quagen
Ingredient:	fluocinonide
Patents:	0

Pharmacology for NDA: 216389

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 216389

Anti-Allergic Agents
Anti-Inflammatory Agents
Glucocorticoids

Suppliers and Packaging for NDA: 216389

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLUOCINONIDE	fluocinonide	SOLUTION;TOPICAL	216389	ANDA	QUAGEN PHARMACEUTICALS LLC	70752-154	70752-154-05	1 BOTTLE in 1 CARTON (70752-154-05) / 60 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;TOPICAL			Strength	0.05%
Approval Date:	Feb 26, 2025	TE:	AT	RLD:	No

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