ANDA 210658, held by Zydus Pharms. Imatinib Mesylate.
As of Nov 15, 2026, ANDA 210658 (Imatinib Mesylate), held by Zydus Pharms, was first approved by FDA on Apr 8, 2020, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 8, 2020 | Original application | Approved | None posted |
| Imatinib MesylateEQ 100MG BASE · tablet;oral | Imatinib Mesylate | Rx |
| Imatinib MesylateEQ 400MG BASE · tablet;oral | Imatinib Mesylate | 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
