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Last Updated: July 28, 2021

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Details for New Drug Application (NDA): 202847

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NDA 202847 describes FLUOCINOLONE ACETONIDE, which is a drug marketed by Alpharma Us Pharms, Cosette, Fougera Pharms Inc, Invatech, Perrigo New York, Pharmafair, Taro, Usl Pharma, Akorn, Amneal, Lyne, Perrigo Israel, Solaris Pharma Corp, Tasman Pharma, Pharmaderm, Actavis Labs Ut Inc, Bausch And Lomb, Encube Ethicals, Glasshouse Pharms, Lupin, and Morton Grove, and is included in fifty-three 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 202847
Applicant:Perrigo Israel
Ingredient:fluocinolone acetonide
Formulation / Manufacturing:see details
Pharmacology for NDA: 202847
Medical Subject Heading (MeSH) Categories for 202847
Suppliers and Packaging for NDA: 202847
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUOCINOLONE ACETONIDE fluocinolone acetonide OIL;TOPICAL 202847 ANDA Perrigo New York Inc 45802-887 45802-887-26 1 BOTTLE in 1 CARTON (45802-887-26) > 118.28 mL in 1 BOTTLE
FLUOCINOLONE ACETONIDE fluocinolone acetonide OIL;TOPICAL 202847 ANDA Bryant Ranch Prepack 63629-8655 63629-8655-1 1 BOTTLE in 1 CARTON (63629-8655-1) > 118.28 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OIL;TOPICALStrength0.01%
Approval Date:Aug 9, 2013TE:ATRLD:No

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