ANDA 78753, held by Hikma. Irinotecan Hydrochloride.
As of Nov 15, 2026, ANDA 78753 (Irinotecan Hydrochloride), held by Hikma, was first approved by FDA on Dec 24, 2008, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 24, 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 |
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
