For metastatic carcinoma of the colon or rectum. ANDA 212993, held by Gland. Irinotecan Hydrochloride.
As of Nov 15, 2026, ANDA 212993 (Irinotecan Hydrochloride), held by Gland, was first approved by FDA on Nov 18, 2019, with 3 approved supplements and 0 published complete response letters.
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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 18, 2019 | Original application | Approved | None posted |
| Irinotecan Hydrochloride40MG/2ML (20MG/ML) · injectable;injection | Irinotecan Hydrochloride | Rx |
| Irinotecan Hydrochloride100MG/5ML (20MG/ML) · injectable;injection | Irinotecan Hydrochloride | Rx |
| Oct 14, 2022 | Supplement 3Labeling · Standard review | Approved | None posted |
| Oct 14, 2022 | Supplement 6Labeling · Standard review | Approved | None posted |
| May 14, 2020 | Supplement 1Labeling · Standard review | Approved | None posted |
| Nov 18, 2019 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
