For metastatic carcinoma of the colon or rectum. ANDA 77776, held by Fresenius Kabi USA. Irinotecan Hydrochloride.
As of Nov 15, 2026, ANDA 77776 (Irinotecan Hydrochloride), held by Fresenius Kabi USA, was first approved by FDA on Feb 27, 2008, with 6 approved supplements and 0 published complete response letters.
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: Patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 27, 2008 | 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 |
| Aug 20, 2025 | Supplement 4Labeling · Standard review | Approved | None posted |
| Aug 20, 2025 | Supplement 5Labeling · Standard review | Approved | None posted |
| Aug 20, 2025 | Supplement 6Labeling · Standard review | Approved | None posted |
| Aug 20, 2025 | Supplement 10Labeling · Standard review | Approved | None posted |
| Aug 20, 2025 | Supplement 12Labeling · Standard review | Approved | None posted |
| Aug 12, 2013 | Supplement 3Labeling · Standard review | Approved | None posted |
| Feb 27, 2008 | 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
