NDA 21335, held by Novartis. Imatinib Mesylate.
As of Nov 14, 2026, NDA 21335 (Gleevec), held by Novartis, was first approved by FDA on May 10, 2001, with 5 approved supplements and 0 published complete response letters.
| May 20, 2003 | Supplement 3Efficacy (new indication or use) · Priority review | Approved | |
| Dec 20, 2002 | Supplement 4Efficacy (new indication or use) · Priority review | Approved | |
| Feb 1, 2002 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| May 10, 2001 | Original applicationNew molecular entity · Priority review | Approved |
| GleevecEQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Imatinib Mesylate | DiscontinuedReference drug |
| GleevecEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Imatinib Mesylate | DiscontinuedReference drug |
| Oct 31, 2003 | Supplement 6Labeling · Priority review | Approved | |
| May 20, 2003 | Supplement 3Efficacy (new indication or use) · Priority review | Approved | |
| Dec 20, 2002 | Supplement 4Efficacy (new indication or use) · Priority review | Approved | |
| Feb 1, 2002 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| Jan 22, 2002 | Supplement 2Manufacturing · Priority review | Approved | |
| May 10, 2001 | 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
