Treats newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia…. ANDA 216261, held by Alembic. Dasatinib.
As of Nov 14, 2026, ANDA 216261 (Dasatinib), held by Alembic, was first approved by FDA on Nov 6, 2025, with 0 approved supplements and 0 published complete response letters.
Dasatinib tablet is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib. Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy. Dasatinib tablet is indicated for the treatment of pediatric patients 1 year of age and older with
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 6, 2025 | 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
