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  FDA Approval Activities for this Drug…

Derma-Smoothe/FS (Fluocinolone Acetonide Topical Oil), Hill Dermaceuticals, NDA 19-452/S-018 4/13/03 Derma-Smoothe/FS (Fluocinolone Acetonide Topical Oil), Hill Dermaceuticals, NDA 19-452/S-17 10/10/01 11/5/01 11/5/01 11/14/01 Derma-Smoothe/FS (Fluocinolone Acetonide Topical Oil), Hill Dermaceuticals, NDA 19-452/S-015 8/19/99 9/24/99 8/24/99 7/3/00 Derma-Smoothe/FS Indication:This supplement approved the treatment of atopic dermatitis in pediatric patients 6 years and older. FLUOCINOLONE ACETONIDE Cream; Topical 0.01% FLUOCINOLONE ACETONIDE FOUGERA 088169 AT FLUOCINOLONE ACETONIDE Cream; Topical 0.025% FLUOCINOLONE ACETONIDE FOUGERA 089526 AT FLUOCINOLONE ACETONIDE Cream; Topical 0.01% FLUOCINOLONE ACETONIDE G AND W 089525 AT FLUOCINOLONE ACETONIDE Cream; Topical 0.025% FLUOCINOLONE ACETONIDE G AND W 012787 AT FLUOCINOLONE ACETONIDE Cream; Topical 0.01% SYNALAR MEDICIS 012787 AT FLUOCINOLONE ACETONIDE Cream; Topical 0.025% SYNALAR MEDICIS 012787 AT FLUOCINOLONE ACETONIDE Cream; Topical 0.025% SYNALAR MEDICIS 087102 AT FLUOCINOLONE ACETONIDE Cream; Topical 0.01% FLUOCINOLONE ACETONIDE Taro 040035 AT FLUOCINOLONE ACETONIDE Cream; Topical 0.01% FLUOCINOLONE ACETONIDE Taro 040042 AT FLUOCINOLONE ACETONIDE Cream; Topical 0.025% FLUOCINOLONE ACETONIDE Taro 087104 AT FLUOCINOLONE ACETONIDE Cream; Topical 0.025% FLUOCINOLONE ACETONIDE Taro 019452 FLUOCINOLONE ACETONIDE Oil; Topical 0.01% DERMA-SMOOTHE/FS HILL DERMAC 088168 AT FLUOCINOLONE ACETONIDE Ointment; Topical 0.025% FLUOCINOLONE ACETONIDE FOUGERA 089524 AT FLUOCINOLONE ACETONIDE Ointment; Topical 0.025% FLUOCINOLONE ACETONIDE G AND W 013960 AT FLUOCINOLONE ACETONIDE Ointment; Topical 0.025% SYNALAR MEDICIS 040041 AT FLUOCINOLONE ACETONIDE Ointment; Topical 0.025% FLUOCINOLONE ACETONIDE Taro 020001 FLUOCINOLONE ACETONIDE Shampoo; Topical 0.01% FS SHAMPOO GALDERMA LP 087159 AT FLUOCINOLONE ACETONIDE Solution; Topical 0.01% FLUOCINOLONE ACETONIDE ALPHARMA 088167 AT FLUOCINOLONE ACETONIDE Solution; Topical 0.01% FLUOCINOLONE ACETONIDE FOUGERA 015296 AT FLUOCINOLONE ACETONIDE Solution; Topical 0.01% SYNALAR MEDICIS 089124 AT FLUOCINOLONE ACETONIDE Solution; Topical 0.01% FLUOCINOLONE ACETONIDE Taro 021112 FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN Cream; Topical 0.01%;4%;0.05% TRI-LUMA HILL DERMAC | Retisert (Fluocinolone Acetonide) Intravitreal Implant, Bausch & Lomb, Approval | Fluocinolone Acetonide Oil Ear Drops, Hill Derma. Approval

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