ANDA 212773, held by Eugia Pharma. Imatinib Mesylate.
As of Nov 15, 2026, ANDA 212773 (Imatinib Mesylate), held by Eugia Pharma, was first approved by FDA on Jul 23, 2020, with 6 approved supplements and 0 published complete response letters.
Imatinib mesylate is a kinase inhibitor indicated for the treatment of: Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy. Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 23, 2020 | Original application | Approved | None posted |
| Imatinib MesylateEQ 100MG BASE · tablet;oral | Imatinib Mesylate | Rx |
| Imatinib MesylateEQ 400MG BASE · tablet;oral | Imatinib Mesylate | Rx |
| Apr 6, 2026 | Supplement 15Labeling · Standard review | Approved | None posted |
| Apr 6, 2026 | Supplement 17Labeling · Standard review | Approved | None posted |
| Jan 31, 2023 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jan 31, 2023 | Supplement 8Labeling · Standard review | Approved | None posted |
| Jan 31, 2023 | Supplement 9Labeling · Standard review | Approved | None posted |
| Jan 31, 2023 | Supplement 10Labeling · Standard review | Approved | None posted |
| Jul 23, 2020 | 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
