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Details for New Drug Application (NDA): 089525

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NDA 089525 describes FLUOCINOLONE ACETONIDE, which is a drug marketed by Taro, Versapharm Inc, Pharmafair, Identi Pharms Inc, Perrigo New York, Morton Grove, Gavis Pharms Llc, G And W Labs, G And W Labs Inc, Usl Pharma, Pharmaderm, Perrigo Israel, Alpharma Us Pharms, Bausch And Lomb, Fougera, Lyne, and Actavis Labs Ut Inc, and is included in forty-five 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 NDA: 089525

Pharmacology for NDA: 089525

Suppliers and Packaging for NDA: 089525

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOCINOLONE ACETONIDE
fluocinolone acetonide
CREAM;TOPICAL 089525 ANDA G&W Laboratories, Inc. 0713-0222 0713-0222-15 1 TUBE in 1 CARTON (0713-0222-15) > 15 g in 1 TUBE
FLUOCINOLONE ACETONIDE
fluocinolone acetonide
CREAM;TOPICAL 089525 ANDA G&W Laboratories, Inc. 0713-0222 0713-0222-60 1 TUBE in 1 CARTON (0713-0222-60) > 60 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength0.025%
Approval Date:Jul 26, 1988TE:ATRLD:No


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