Key Data Files for this Active Pharmaceutical Ingredient:

Drug Master Files, 21 CFR, and other industry portals Patent/Exclusivity data file Drug Approval Drug Safety Freedom of Information Federal Register pages Pharma Companies Pharmacopeial Information Preferred API Supplier (Clients Only)

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   For the latest approval information, locate this drug using this index.