NDA 21029, held by Merck Sharp Dohme. Temozolomide.
As of Nov 14, 2026, NDA 21029 (Temodar), held by Merck Sharp Dohme, was first approved by FDA on Aug 11, 1999, with 30 approved supplements and 0 published complete response letters.
TEMODAR is an alkylating drug indicated for the treatment of adults with: Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. Anaplastic astrocytoma. Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. Treatment of adults with refractory anaplastic astrocytoma. 1.1 Newly Diagnosed Glioblastoma TEMODAR is indicated for the treatment of adults with newly diagnosed glioblastoma, concomitantly with radiotherapy and then as maintenance treatment. 1.
| Sep 14, 2023 | Supplement 38Efficacy (new indication or use) · Standard review | Approved | |
| Sep 14, 2023 | Supplement 37Efficacy (new indication or use) · Standard review | Approved | |
| Sep 14, 2023 | Supplement 36Efficacy (new indication or use) · Standard review | Approved | |
| Mar 15, 2005 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| Mar 11, 2003 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| Aug 11, 1999 | Original applicationNew molecular entity · Priority review | Approved |
| Temodar5MG · capsule;oral | Temozolomide | DiscontinuedReference drug |
| Temodar20MG · capsule;oral | Temozolomide | DiscontinuedReference drug |
| Temodar100MG · capsule;oral | Temozolomide | DiscontinuedReference drug |
| Temodar250MG · capsule;oral | Temozolomide | DiscontinuedReference drug |
| Temodar140MG · capsule;oral | Temozolomide | DiscontinuedReference drug |
| Temodar180MG · capsule;oral | Temozolomide | DiscontinuedReference drug |
| Sep 14, 2023 | Supplement 38Efficacy (new indication or use) · Standard review | Approved | |
| Sep 14, 2023 | Supplement 37Efficacy (new indication or use) · Standard review | Approved | |
| Sep 14, 2023 | Supplement 36Efficacy (new indication or use) · Standard review | Approved | |
| Nov 20, 2020 | Supplement 35Labeling · Standard review | Approved | |
| Nov 22, 2019 | Supplement 33Labeling · Standard review | Approved | |
| Oct 6, 2017 | Supplement 32Labeling · Standard review | Approved | |
| Feb 24, 2017 | Supplement 30Labeling · Standard review | Approved | |
| Feb 12, 2016 | Supplement 31Labeling · Standard review | Approved | |
| Sep 18, 2015 | Supplement 29Labeling · Standard review | Approved | |
| Apr 2, 2015 | Supplement 28Labeling · Standard review | Approved | |
| Sep 19, 2014 | Supplement 27Manufacturing · Priority review | Approved | None posted |
| May 5, 2014 | Supplement 26Labeling · Standard review | Approved | |
| Mar 20, 2014 | Supplement 24Manufacturing · Priority review | Approved | None posted |
| Oct 10, 2013 | Supplement 25Manufacturing · Priority review | Approved | None posted |
| Jan 8, 2013 | Supplement 22Manufacturing · Priority review | Approved | |
| Jun 3, 2011 | Supplement 21Labeling | Approved | |
| Feb 4, 2011 | Supplement 20Labeling | Approved | |
| Apr 26, 2010 | Supplement 18Labeling · Standard review | Approved | |
| Oct 19, 2006 | Supplement 12Manufacturing | Approved | |
| Mar 31, 2006 | Supplement 11Labeling · Standard review | Approved | |
| Apr 22, 2005 | Supplement 10Labeling · Standard review | Approved | |
| Mar 30, 2005 | Supplement 9Labeling · Standard review | Approved | |
| Mar 15, 2005 | Supplement 8Efficacy (new indication or use) · Priority review | Approved | |
| Jul 15, 2004 | Supplement 6Labeling · Standard review | Approved | |
| Jun 29, 2004 | Supplement 7Labeling · Standard review | Approved | |
| Mar 11, 2003 | Supplement 5Efficacy (new indication or use) · Priority review | Approved | |
| Mar 5, 2002 | Supplement 3Manufacturing · Priority review | Approved | None posted |
| Jan 18, 2002 | Supplement 4Labeling · Standard review | Approved | |
| May 18, 2001 | Supplement 2Manufacturing · Priority review | Approved | None posted |
| Jun 9, 2000 | Supplement 1Manufacturing · Priority review | Approved | None posted |
| Aug 11, 1999 | 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
