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Last Updated: December 28, 2025

Details for New Drug Application (NDA): 213264

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NDA 213264 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 Inc, 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. Twenty-one suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.

Summary for 213264

Tradename:	FLUOCINOLONE ACETONIDE
Applicant:	Tp Anda Holdings
Ingredient:	fluocinolone acetonide
Patents:	0

Medical Subject Heading (MeSH) Categories for 213264

Anti-Inflammatory Agents
Glucocorticoids

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	OIL/DROPS;OTIC			Strength	0.01%
Approval Date:	Feb 5, 2021	TE:	AT	RLD:	No

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