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As of Nov 14, 2026, ANDA 203180 (Dasatinib), held by Apotex, was first approved by FDA on Nov 23, 2021, with 3 approved supplements and 0 published complete response letters.
First approved: Nov 23, 2021
Supplements approved: 3
Complete response letters: 0
What It's For
From the FDA-approved label (Indications and Usage)
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. Dasatinib tablets are indicated for the treatment of pediatric patients 1 year of age and older with Ph+ CML in chronic phase. newly diagnosed Ph+ ALL in combination with chemotherapy.
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
