ANDA 78122, held by Pliva Lachema. Irinotecan Hydrochloride.
As of Nov 15, 2026, ANDA 78122 (Irinotecan Hydrochloride), held by Pliva Lachema, was first approved by FDA on Oct 31, 2008, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 31, 2008 | Original application | Approved | None posted |
| Irinotecan Hydrochloride40MG/2ML (20MG/ML) · injectable;injection | Irinotecan Hydrochloride | Discontinued |
| Irinotecan Hydrochloride100MG/5ML (20MG/ML) · injectable;injection | Irinotecan Hydrochloride | Discontinued |
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
