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… Xeloda (Capecitabine) Tablets, Hoffman-LaRoche Inc NDA 20-896/S12 3/15/03 3/26/03 3/26/03 Xeloda (Capecitabine) Tablets, Roche NDA 20-896/S10 & 11 9/7/01 11/6/01 9/12/01 11/7/01 Xeloda Indications: For the treatment of patients with locally advanced or metastatic breast cancer after failure of prior anthacycline containing chemotherapy. SLR-011 added a black box warning for drug-drug interaction with warfarin. Xeloda capecitabine Tablets, 150 mg and 500 mg, Roche NDA 20-896/S6, S9 4/30/01 2/6/02 04/25/03 2/6/02 Xeloda capecitabine Tablets, 150 mg and 500 mg, Hoffman-La Roche NDA 20-896   For the latest approval information, locate this drug using this index.