Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Safety Information For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

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 ^ FDA's latest approval appears at the bottom of this list. ^                                                                       A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | For Industry | DMF Index | Pharma Job Search | Pharma Company News | Best Phone © 2012 Betterchem.com