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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 209336

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NDA 209336 describes FLUOCINOLONE ACETONIDE, which is a drug marketed by Allied, Alpharma Us Pharms, Cosette, 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 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 209336

Tradename:	FLUOCINOLONE ACETONIDE
Applicant:	Sun Pharma Canada
Ingredient:	fluocinolone acetonide
Patents:	0

Pharmacology for NDA: 209336

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 209336

Anti-Inflammatory Agents
Glucocorticoids

Suppliers and Packaging for NDA: 209336

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLUOCINOLONE ACETONIDE	fluocinolone acetonide	OIL;TOPICAL	209336	ANDA	Sun Pharmaceutical Industries, Inc.	51672-1357	51672-1357-8	1 BOTTLE in 1 CARTON (51672-1357-8) / 118.28 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	OIL;TOPICAL			Strength	0.01%
Approval Date:	May 19, 2016	TE:	AT	RLD:	No

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