For metastatic carcinoma of the colon or rectum. ANDA 213278, held by Eugia Pharma. Irinotecan Hydrochloride.
As of Nov 15, 2026, ANDA 213278 (Irinotecan Hydrochloride), held by Eugia Pharma, was first approved by FDA on Nov 2, 2020, with 1 approved supplement 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. 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 2, 2020 | 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 |
| Irinotecan Hydrochloride300MG/15ML (20MG/ML) · injectable;injection | Irinotecan Hydrochloride | Rx |
| Irinotecan Hydrochloride500MG/25ML (20MG/ML) · injectable;injection | Irinotecan Hydrochloride | Rx |
| Apr 11, 2022 | Supplement 1Manufacturing | Approved | None posted |
| Nov 2, 2020 | 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
