NDA 21968, held by Cppi Cv. Sunitinib Malate.
As of Nov 13, 2026, NDA 21968 (Sutent), held by Cppi Cv, was first approved by FDA on Jan 26, 2006, with 6 approved supplements and 0 published complete response letters.
| Feb 2, 2007 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Feb 2, 2007 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Feb 2, 2007 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| Feb 2, 2007 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | |
| Jan 26, 2006 | Original applicationTYPE 6 · Priority review | Approved |
| SutentEQ 12.5MG BASE · capsule; oral | Sunitinib Malate | Rx |
| SutentEQ 25MG BASE · capsule; oral | Sunitinib Malate | Rx |
| SutentEQ 50MG BASE · capsule; oral | Sunitinib Malate | Rx |
| Feb 2, 2007 | Supplement 2Labeling · Standard review | Approved | |
| Feb 2, 2007 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Feb 2, 2007 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Feb 2, 2007 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| Feb 2, 2007 | Supplement 6Efficacy (new indication or use) · Priority review | Approved | |
| May 10, 2006 | Supplement 1Manufacturing | Approved | None posted |
| Jan 26, 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
