Treats Newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia…. ANDA 218719, held by Zydus Pharms. Dasatinib.
As of Nov 14, 2026, ANDA 218719 (Dasatinib), held by Zydus Pharms, was first approved by FDA on Mar 3, 2025, with 0 approved supplements and 0 published complete response letters.
Dasatinib tablets are 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. Pediatric use information is approved for Bristol-Myers Squibb Company's Sprycel (dasatinib) tablets. However, due to Bristol-Myers Squibb Company's marketing exclusivity rights, this drug product is not labeled with that pediatric information.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 3, 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
