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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 202849

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NDA 202849 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 202849

Tradename:	FLUOCINOLONE ACETONIDE
Applicant:	Padagis Israel
Ingredient:	fluocinolone acetonide
Patents:	0

Pharmacology for NDA: 202849

Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 202849

Anti-Inflammatory Agents
Glucocorticoids

Suppliers and Packaging for NDA: 202849

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
FLUOCINOLONE ACETONIDE	fluocinolone acetonide	OIL/DROPS;OTIC	202849	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-009	45802-009-10	1 BOTTLE in 1 CARTON (45802-009-10) / 20 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	OIL/DROPS;OTIC			Strength	0.01%
Approval Date:	Jul 17, 2017	TE:	AT	RLD:	No

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