Last Updated: November 8, 2026

Details for New Drug Application (NDA): 088167

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NDA 088167 describes FLUOCINOLONE ACETONIDE, which is a drug marketed by Allied, Alpharma Us Pharms, Cosette Pharms Nc, Fougera Pharms Inc, Invatech, Perrigo New York, Pharmafair, Sun Pharma Canada, Usl Pharma, Amneal, Padagis Israel, Quagen, Rising, Sciegen Pharms, Tp Anda Holdings, Glenmark Pharms Ltd, Novel Labs Inc, Pharmaderm, Actavis Labs Ut Inc, Bausch And Lomb, Chartwell Rx, Encube Ethicals, Lupin, and Pai Holdings Pharm, and is included in fifty-six NDAs. It is available from thirteen suppliers. Additional details are available on the FLUOCINOLONE ACETONIDE profile page.

The generic ingredient in FLUOCINOLONE ACETONIDE is fluocinolone acetonide. There is one drug master file entry for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.

Summary for 088167

Tradename:	FLUOCINOLONE ACETONIDE
Applicant:	Fougera Pharms Inc
Ingredient:	fluocinolone acetonide
Patents:	0

Pharmacology for NDA: 088167

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 088167

Anti-Inflammatory Agents
Glucocorticoids

Suppliers and Packaging for NDA: 088167

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLUOCINOLONE ACETONIDE	fluocinolone acetonide	SOLUTION;TOPICAL	088167	ANDA	Fougera Pharmaceuticals, LLC	0168-0059	0168-0059-60	60 mL in 1 BOTTLE (0168-0059-60)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;TOPICAL			Strength	0.01%
Approval Date:	Dec 16, 1982	TE:	AT	RLD:	No

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