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Last Updated: December 28, 2025

Details for New Drug Application (NDA): 203378

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NDA 203378 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 203378

Tradename:	FLUOCINOLONE ACETONIDE
Applicant:	Rising
Ingredient:	fluocinolone acetonide
Patents:	0

Pharmacology for NDA: 203378

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 203378

Anti-Inflammatory Agents
Glucocorticoids

Suppliers and Packaging for NDA: 203378

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLUOCINOLONE ACETONIDE	fluocinolone acetonide	OIL/DROPS;OTIC	203378	ANDA	Rising Pharma Holdings, Inc.	64980-329	64980-329-20	20 mL in 1 BOTTLE (64980-329-20)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	OIL/DROPS;OTIC			Strength	0.01%
Approval Date:	Apr 25, 2016	TE:	AT	RLD:	No

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