ANDA 90726, held by Epic Pharma LLC. Irinotecan Hydrochloride.
As of Nov 15, 2026, ANDA 90726 (Irinotecan Hydrochloride), held by Epic Pharma LLC, was first approved by FDA on Sep 16, 2009, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 16, 2009 | 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
