FDA Approval Activities for this Drug…

Fluorouracil Cream USP, 0.5%, Dermik , NDA 20-985 10/27/00 10/31/00 10/31/00 4/25/03 Fluorouracil Indication: for the topical treatment of multiple actinic or solar keratosis of the face and anterior scalp. Fluorouracil Injection, 500 mg/10 mL vial ICN NDA 12-209/S038 1/20/99 6/15/01 Fluorouracil Injection USP, 10 mL and 20 mL vials American Pharmaceutical Partners ANDA 40-279 9/30/98 10/5/98 8/4/03 Fluorouracil Injection USP, 50 mL and 100 mL vials, Pharmacy Bulk Package American Pharmaceutical Partners ANDA 40-278 9/30/98 10/5/98 8/4/03 Fluorouracil Injection USP, 50 mg/mL, 100 mL, Bigmar, ANDA 40-379 11/15/00 11/17/00 1/17/02 Fluorouracil Injection USP,50 mg/mL, 100 mL, Gensia Sicor ANDA 40-334 2/25/00 8/4/03 Fluorouracil Injection USP,50 mg/mL, 10 mL, Gensia Sicor ANDA 40-333 1/27/00 2/4/00 Fluorouracil Injection USP, 50 mg/mL, in 250 mg/5 mL and 500 mg/10 mL vials Bigmar, ANDA 40-291 Fluorouracil Topical Solution, Taro FLUOROURACIL Cream; Topical 1% FLUOROPLEX ALLERGAN HERBERT 020985 FLUOROURACIL Cream; Topical 0.5% CARAC DERMIK 016831 FLUOROURACIL Cream; Topical 5% EFUDEX ICN 040278 FLUOROURACIL Injection 50MG/ML FLUOROURACIL AM PARTNERS 040279 FLUOROURACIL Injection 50MG/ML FLUOROURACIL AM PARTNERS 089508 FLUOROURACIL Injection 50MG/ML FLUOROURACIL Bedford 040379 FLUOROURACIL Injection 50MG/ML FLUOROURACIL BIGMAR 040291 FLUOROURACIL Injection 50MG/ML FLUOROURACIL BIGMAR 040023 FLUOROURACIL Injection 50MG/ML ADRUCIL Gensia Sicor 081225 FLUOROURACIL Injection 50MG/ML ADRUCIL Gensia Sicor 012209 FLUOROURACIL Injection 50MG/ML FLUOROURACIL ICN PUERTO RICO 040333 FLUOROURACIL Injection 50MG/ML FLUOROURACIL Sicor 040334 FLUOROURACIL Injection 50MG/ML FLUOROURACIL Sicor 087792 FLUOROURACIL Injection 50MG/ML FLUOROURACIL STERIS 016831 FLUOROURACIL Solution; Topical 2% EFUDEX ICN 016831 FLUOROURACIL Solution; Topical 5% EFUDEX ICN Carac (Fluorouracil) Cream, Dermik Laboratories Efudex (fluorouracil) Topical Solution, ICN Pharmaceuticals Efudex (fluorouracil) Topical Cream, Valeant Pharmaceuticals

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