NDA 22072, held by Bristol Myers Squibb. Dasatinib.
As of Nov 14, 2026, NDA 22072 (Sprycel), held by Bristol Myers Squibb, was first approved by FDA on Jun 28, 2006, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 28, 2006 | Original applicationTYPE 6 · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Sprycel70MG · tablet; oral | Dasatinib | Rx |
| Jul 28, 2010 | Supplement 2Labeling · Standard review | Approved | |
| May 30, 2008 | Supplement 1Manufacturing | Approved | |
| Jun 28, 2006 | Original applicationTYPE 6 · 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
