ANDA 207818, held by Natco Pharma Ltd. Imatinib Mesylate.
As of Nov 15, 2026, ANDA 207818 (Imatinib Mesylate), held by Natco Pharma Ltd, was first approved by FDA on Mar 1, 2019, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 1, 2019 | Original application | Approved | None posted |
| Imatinib MesylateEQ 100MG BASE · tablet;oral | Imatinib Mesylate | Rx |
| Imatinib MesylateEQ 400MG BASE · tablet;oral | Imatinib Mesylate | Rx |
| Feb 8, 2024 | Supplement 1Labeling · Standard review | Approved | None posted |
| Feb 8, 2024 | Supplement 3Labeling · Standard review | Approved | None posted |
| Mar 1, 2019 | Original application | Approved | None posted |
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
