Last Updated: September 24, 2026

Details for New Drug Application (NDA): 207345

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NDA 207345 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. Nineteen suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.

Summary for 207345

Tradename:	FLUOCINOLONE ACETONIDE
Applicant:	Novel Labs Inc
Ingredient:	fluocinolone acetonide
Patents:	0

Medical Subject Heading (MeSH) Categories for 207345

Anti-Inflammatory Agents
Glucocorticoids

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	OIL;TOPICAL			Strength	0.01%
Approval Date:	Jul 31, 2023	TE:	AT	RLD:	No

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