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Last Updated: December 11, 2019

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Details for New Drug Application (NDA): 088361

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NDA 088361 describes FLUOCINOLONE ACETONIDE, which is a drug marketed by Acp Nimble, Alpharma Us Pharms, Fougera Pharms Inc, Perrigo New York, Pharmaderm, Pharmafair, Taro, Usl Pharma, Akorn, Identi Pharms Inc, Lyne, Perrigo Israel, Actavis Labs Ut Inc, Bausch And Lomb, Encube Ethicals, Glasshouse Pharms, Lupin, and Morton Grove, and is included in forty-nine NDAs. It is available from sixteen 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-seven suppliers are listed for this compound. Additional details are available on the fluocinolone acetonide profile page.
Summary for 088361
Applicant:Alpharma Us Pharms
Ingredient:fluocinolone acetonide
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 088361

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CREAM;TOPICALStrength0.01%
Approval Date:Jan 16, 1984TE:RLD:No

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