FDA Approval Activities for this Drug…

Camptosar (irinotecan HCl injection), Pharmacia & Upjohn Co. NDA 20-571/S-016 5/16/02 5/21/02 5/16/02 Camptosar (irinotecan hydrochlorise injection)20 mg/mL Intravenous, Pharmacia & Upjohn NDA 20-571/S-008 10/22/98 10/26/98 10/26/98 7/21/99 Camptosar: Treatment of patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following 5-FU-based therapy. Camptosar Injection (irinotecan hydrochloride injection), . Pharmacia & Upjohn NDA 20-571/S-009 4/20/00 4/24/00 4/24/00 6/4/01 Camptosar Indication: A component of first-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum. CAMPTOSAR Injection (irinotecan hydrochloride), Pfizer | CAMPTOSAR (irinotecan hydrochloride) Injection, Pfizer, Labeling Revision

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