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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 FLUOCINOLONE ACETONIDE Cream; Topical 0.025% FLUOCINOLONE ACETONIDE FOUGERA
| 089526 FLUOCINOLONE ACETONIDE Cream; Topical 0.01% FLUOCINOLONE ACETONIDE G AND W | 089525 FLUOCINOLONE ACETONIDE Cream; Topical 0.025% FLUOCINOLONE ACETONIDE G AND W | 012787 FLUOCINOLONE ACETONIDE Cream; Topical 0.01% SYNALAR MEDICIS
| 012787 FLUOCINOLONE ACETONIDE Cream; Topical 0.025% SYNALAR MEDICIS
| 012787 FLUOCINOLONE ACETONIDE Cream; Topical 0.025% SYNALAR MEDICIS
| 087102 FLUOCINOLONE ACETONIDE Cream; Topical 0.01% FLUOCINOLONE ACETONIDE Taro
| 040035 FLUOCINOLONE ACETONIDE Cream; Topical 0.01% FLUOCINOLONE ACETONIDE Taro
| 040042 FLUOCINOLONE ACETONIDE Cream; Topical 0.025% FLUOCINOLONE ACETONIDE Taro
| 087104 FLUOCINOLONE ACETONIDE Cream; Topical 0.025% FLUOCINOLONE ACETONIDE Taro
| 019452 FLUOCINOLONE ACETONIDE Oil; Topical 0.01% DERMA-SMOOTHE/FS HILL DERMAC
| 088168 FLUOCINOLONE ACETONIDE Ointment; Topical 0.025% FLUOCINOLONE ACETONIDE FOUGERA
| 089524 FLUOCINOLONE ACETONIDE Ointment; Topical 0.025% FLUOCINOLONE ACETONIDE G AND W | 013960 FLUOCINOLONE ACETONIDE Ointment; Topical 0.025% SYNALAR MEDICIS
| 040041 FLUOCINOLONE ACETONIDE Ointment; Topical 0.025% FLUOCINOLONE ACETONIDE Taro
| 020001 FLUOCINOLONE ACETONIDE Shampoo; Topical 0.01% FS SHAMPOO GALDERMA LP
| 087159 FLUOCINOLONE ACETONIDE Solution; Topical 0.01% FLUOCINOLONE ACETONIDE ALPHARMA
| 088167 FLUOCINOLONE ACETONIDE Solution; Topical 0.01% FLUOCINOLONE ACETONIDE FOUGERA
| 015296 FLUOCINOLONE ACETONIDE Solution; Topical 0.01% SYNALAR MEDICIS
| 089124 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 | Retisert (fluocinolone acetonide) Intravitreal Implant, Bausch & Lomb, Labeling Revision
| Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil, Hill Dermaceuticals, Patient Population Altered | Retisert (fluocinolone acetonide) Intravitreal Implant, Bausch & Lomb, Inc., Efficacy Supplement with Clinical Data to Support | Retisert (fluocinolone acetonide) Intravitreal Implant, Bausch & Lomb, Inc., Manufacturing Supplement | Retisert (fluocinolone acetonide) Implant, Bausch & Lomb, Inc., Manufacturing Change or Addition | Fluocinolone Acetonide Drops, Identi Pharmaceuticals Inc., Approval | Fluocinolone Acetonide Topical Oil, Identi Pharmaceuticals Inc., Approval | Fluocinolone Acetonide Topical Oil, Identi Pharmaceuticals Inc., Approval
^ FDA's latest approval appears the bottom of this list. ^
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