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fluocinolone acetonide

FDA Drug Profile — fluocinolone acetonide, Iluvien, Fluocinolone Acetonide, Flac Otic Oil, Derma-Smoothe/FS

Drug Details

Generic Name
fluocinolone acetonide
Brand Names
fluocinolone acetonide, Iluvien, Fluocinolone Acetonide, Flac Otic Oil, Derma-Smoothe/FS, FLUOCINOLONE ACETONIDE, Synalar, FLUOCINOLONE ACETONIDE Oil, DERMA-SMOOTHE/FS, DERMOTIC
Application Number
ANDA202847
Sponsor
Padagis Israel Pharmaceuticals Ltd
NDC Codes
27
Dosage Forms
OIL, IMPLANT, CREAM, SOLUTION, OINTMENT
Routes
TOPICAL, INTRAVITREAL, AURICULAR (OTIC)
Active Ingredients
FLUOCINOLONE ACETONIDE

Indications and Usage

INDICATION AND USAGE Fluocinolone acetonide oil, 0.01% is a low to medium potency corticosteroid indicated for the treatment of chronic eczematous external otitis in adults and pediatric patients 2 years and older.