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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 212976

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NDA 212976 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, 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 twelve 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 212976

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

Pharmacology for NDA: 212976

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 212976

Anti-Allergic Agents
Anti-Inflammatory Agents
Glucocorticoids

Suppliers and Packaging for NDA: 212976

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLUOCINONIDE	fluocinonide	OINTMENT;TOPICAL	212976	ANDA	Bryant Ranch Prepack	63629-2337	63629-2337-1	1 TUBE in 1 CARTON (63629-2337-1) / 60 g in 1 TUBE
FLUOCINONIDE	fluocinonide	OINTMENT;TOPICAL	212976	ANDA	Bryant Ranch Prepack	63629-2338	63629-2338-1	1 TUBE in 1 CARTON (63629-2338-1) / 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	OINTMENT;TOPICAL			Strength	0.05%
Approval Date:	Nov 26, 2019	TE:	AB	RLD:	No

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