Irinotecan hydrochloide
Irinotecan hydrochloide is listed in the FDA National Drug Code directory with 3 NDC codes, marketed under brand name including Irinotecan hydrochloide. Available dosage form: injection.
Drug Details
- Generic Name
- Irinotecan hydrochloide
- Brand Names
- Irinotecan hydrochloide
- Application Number
- ANDA212993
- Sponsor
- Gland Pharma Limited
- NDC Codes
- 3
- Dosage Forms
- INJECTION
- Routes
- INTRAVENOUS
- Active Ingredients
- IRINOTECAN HYDROCHLORIDE
Indications and Usage
1 INDICATIONS AND USAGE Irinotecan hydrochloride injection is indicated as a component of first-line therapy in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for patients with metastatic carcinoma of the colon or rectum. Irinotecan hydrochloride injection is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. Irinotecan hydrochloride injection is a topoisomerase inhibitor indicated for: • First-line therapy in combination with 5-fluorouracil and leucovorin for patients with metastatic carcinoma of the colon or rectum. ( 1 ) • Patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. ( 1 )