Treats newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia…. NDA 21986, held by Bristol Myers Squibb. Dasatinib.
As of Nov 15, 2026, NDA 21986 (Sprycel), held by Bristol Myers Squibb, was first approved by FDA on Jun 28, 2006, with 23 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. 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.
| Dec 21, 2018 | Supplement 21Efficacy (new indication or use) · Priority review | Approved | |
| Nov 9, 2017 | Supplement 20Efficacy (new indication or use) · Priority review | Approved | |
| Aug 12, 2015 | Supplement 16Efficacy (new indication or use) · Standard review | Approved | |
| Jun 17, 2013 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Oct 28, 2010 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| Oct 28, 2010 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| May 21, 2009 | Supplement 4Efficacy (new indication or use) | Approved | |
| Nov 8, 2007 | Supplement 2Efficacy (new indication or use) | Approved | |
| Nov 8, 2007 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| Jun 28, 2006 | Original applicationNew molecular entity · Priority review | Approved |
| Sprycel20MG · tablet;oral | Dasatinib | RxReference drug |
| Sprycel50MG · tablet;oral | Dasatinib | RxReference drug |
| Sprycel70MG · tablet;oral | Dasatinib | RxReference drug |
| Sprycel100MG · tablet;oral | Dasatinib | RxReference drug |
| Sprycel80MG · tablet;oral | Dasatinib | RxReference drug |
| Sprycel140MG · tablet;oral | Dasatinib | RxReference drug |
| Oct 16, 2026 | Supplement 29Labeling · Standard review | Approved | |
| Jul 31, 2024 | Supplement 28Labeling · Standard review | Approved | |
| Feb 8, 2023 | Supplement 27Labeling · Standard review | Approved | |
| Jun 29, 2021 | Supplement 25Labeling · Standard review | Approved | |
| Dec 21, 2018 | Supplement 21Efficacy (new indication or use) · Priority review | Approved | |
| Nov 15, 2018 | Supplement 23Labeling · Standard review | Approved | |
| Nov 9, 2017 | Supplement 20Efficacy (new indication or use) · Priority review | Approved | |
| Aug 10, 2017 | Supplement 19Labeling · Standard review | Approved | |
| Sep 27, 2016 | Supplement 18Labeling · Standard review | Approved | |
| Aug 12, 2015 | Supplement 17Labeling · Standard review | Approved | |
| Aug 12, 2015 | Supplement 16Efficacy (new indication or use) · Standard review | Approved | |
| Jan 26, 2015 | Supplement 15Manufacturing · Priority review | Approved | None posted |
| Apr 10, 2014 | Supplement 14Labeling · Standard review | Approved | |
| Jun 17, 2013 | Supplement 13Efficacy (new indication or use) · Standard review | Approved | |
| Oct 7, 2011 | Supplement 10Labeling | Approved | |
| Oct 7, 2011 | Supplement 9Labeling | Approved | |
| Oct 28, 2010 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| Oct 28, 2010 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Jul 28, 2010 | Supplement 5Labeling · Standard review | Approved | |
| May 21, 2009 | Supplement 4Efficacy (new indication or use) | Approved | |
| May 30, 2008 | Supplement 3Manufacturing | Approved | |
| Nov 8, 2007 | Supplement 2Efficacy (new indication or use) | Approved | |
| Nov 8, 2007 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| Jun 28, 2006 | Original applicationNew molecular entity · Priority review | Approved |
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
