For Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase…. ANDA 208302, held by Shilpa. Imatinib Mesylate.
As of Nov 15, 2026, ANDA 208302 (Imatinib Mesylate), held by Shilpa, was first approved by FDA on Jan 17, 2019, with 3 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) Adult patients with myelodysplastic/ myeloproliferative diseases (MDS/MPD) associated with PDGFR (platelet-derived growth factor receptor) gene re-arrangements as determined with an F…
| 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 |
| Jun 9, 2023 | Supplement 7Labeling · Standard review | Approved | None posted |
| Jun 9, 2023 | Supplement 6Labeling · Standard review | Approved | None posted |
| Jun 9, 2023 | 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
