← FDA DRUG APPROVALS

FDA NDA · NDA021029

TEMODAR

temozolomide

Sponsor: MERCK SHARP DOHME

APPLICATION
NDA021029
TYPE
NDA
ORIGINAL APPROVAL
1999-08-11
LATEST ACTION
2023-09-14
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

TEMODAR · ReferenceDiscontinued
TEMOZOLOMIDE 140MG · CAPSULE · ORAL
TEMODAR · ReferenceDiscontinued
TEMOZOLOMIDE 100MG · CAPSULE · ORAL
TEMODAR · ReferenceDiscontinued
TEMOZOLOMIDE 5MG · CAPSULE · ORAL
TEMODAR · ReferenceDiscontinued
TEMOZOLOMIDE 180MG · CAPSULE · ORAL
TEMODAR · ReferenceDiscontinued
TEMOZOLOMIDE 250MG · CAPSULE · ORAL
TEMODAR · ReferenceDiscontinued
TEMOZOLOMIDE 20MG · CAPSULE · ORAL

Approval history

2023-09-14Efficacy · Supplement 37 · standard — Label ↗AP
2023-09-14Efficacy · Supplement 38 · standard — Label ↗AP
2023-09-14Efficacy · Supplement 36 · standard — Label ↗AP
2020-11-20Labeling · Supplement 35 · standard — Letter ↗AP
2019-11-22Labeling · Supplement 33 · standard — Label ↗AP
2017-10-06Labeling · Supplement 32 · standard — Label ↗AP
2017-02-24Labeling · Supplement 30 · standard — Label ↗AP
2016-02-12Labeling · Supplement 31 · standard — Label ↗AP
2015-09-18Labeling · Supplement 29 · standard — Letter ↗AP
2015-04-02Labeling · Supplement 28 · standard — Letter ↗AP
2014-09-19Manufacturing (CMC) · Supplement 27 · priorityAP
2014-05-05Labeling · Supplement 26 · standard — Letter ↗AP
2014-03-20Manufacturing (CMC) · Supplement 24 · priorityAP
2013-10-10Manufacturing (CMC) · Supplement 25 · priorityAP
2013-01-08Manufacturing (CMC) · Supplement 22 · priority — Label ↗AP
2011-06-03Labeling · Supplement 21 · unknown — Letter ↗AP
2011-02-04Labeling · Supplement 20 · unknown — Label ↗AP
2010-04-26Labeling · Supplement 18 · standard — Label ↗AP
2006-10-19Manufacturing (CMC) · Supplement 12 — Letter ↗AP
2006-03-31Labeling · Supplement 11 · standard — Letter ↗AP
2005-04-22Labeling · Supplement 10 · standard — Letter ↗AP
2005-03-30Labeling · Supplement 9 · standard — Letter ↗AP
2005-03-15Efficacy · Supplement 8 · priority — Letter ↗AP
2004-07-15Labeling · Supplement 6 · standard — Letter ↗AP
2004-06-29Labeling · Supplement 7 · standard — Letter ↗AP
2003-03-11Efficacy · Supplement 5 · priority — Pediatric Medical Review ↗AP
2002-03-05Manufacturing (CMC) · Supplement 3 · priorityAP
2002-01-18Labeling · Supplement 4 · standard — Review ↗AP
2001-05-18Manufacturing (CMC) · Supplement 2 · priorityAP
2000-06-09Manufacturing (CMC) · Supplement 1 · priorityAP
1999-08-11Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →