ANDA 212193, held by Cspc Ouyi. Imatinib Mesylate.
As of Nov 15, 2026, ANDA 212193 (Imatinib Mesylate), held by Cspc Ouyi, was first approved by FDA on Apr 21, 2025, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 21, 2025 | 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
