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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 | CAMPTOSAR (irinotecan hydrochloride) injection, Pfizer, Labeling Revision | Camptosar (irinotecan hydrochloride) injection, Pfizer, Inc., Labeling Revisions | Camptosar (Irinotecan Hydrochloride) Injection, Pfizer, Labeling Revision | Camptosar (Irinotecan Hydrochloride) Injection, Pfizer, Inc., Labeling Revision | Irinotecan Hydrochloride Injection, Watson Labs, Tentative Approval | Irinotecan Hydrochloride Injection, Abraxis Pharma, Tentative Approval | Irinotecan Hydrochloride Injection, Dabur Oncology, Tentative Approval | Irinotecan Hydrochloride Injection, Teva Parenteral, Tentative Approval | Irinotecan Hydrochloride Injection, Watson Labs, Approval | Irinotecan Hydrochloride Injection, APP Pharma, Approval | Irinotecan Hydrochloride Injection, Teva Parenteral, Approval | Irinotecan Hydrochloride Injection, Actavis Totowa, Approval | Irinotecan Hydrochloride Injection, Hospira Inc., Approval | Irinotecan Hydrochloride Injection, Dabur Oncology, Approval | Irinotecan Hydrochloride Injection, Sandoz Inc., Approval | Irinotecan Hydrochloride Injection, Sun Pharma, Approval | Irinotecan Hydrochloride Injection, 'Pliva-Lachema, AS, Approval | Irinotecan Hydrochloride Injection, Accord Healthcare Inc., USA, Approval | Irinotecan Hydrochloride Injection, Teva Parenteral Medicines, Inc., Approval | Irinotecan Hydrochloride Injection, Bedford Laboratories, Approval | Irinotecan Hydrochloride Injection, X-GEN Pharmaceuticals, Inc., Approval | Irinotecan Hydrochloride Injection, Akorn, Inc., Approval | Irinotecan hydrochloride Injection, Ebewe Pharmaceutical, Approval | Irinotecan Hydrochloride Injection, Dr. Reddy's Laboratories, Ltd., Approval | Camptosar (irinotecan hydrochloride) Injection, Pfizer, Inc., Labeling Revision | Irinotecan Hydrochloride Injection, Hikma Farmaceutica (Portugal), S.A., Approval | Irinotecan Hydrochloride Injection, Bioniche Pharma USA LLC., Approval
  
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