ANDA 208429, held by Chartwell Rx. Imatinib Mesylate.
As of Nov 15, 2026, ANDA 208429 (Imatinib Mesylate), held by Chartwell Rx, was first approved by FDA on Jan 17, 2019, with 1 approved supplement 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 |
|---|---|---|---|
| Jan 17, 2019 | Original application | Approved | None posted |
| Imatinib MesylateEQ 100MG BASE · tablet;oral | Imatinib Mesylate | Rx |
| Imatinib MesylateEQ 400MG BASE · tablet;oral | Imatinib Mesylate | Rx |
| Jan 8, 2025 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jan 17, 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
