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

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