← FDA DRUG APPROVALS

FDA NDA · NDA020449

DOCETAXEL

Sponsor: SANOFI AVENTIS US

APPLICATION
NDA020449
TYPE
NDA
ORIGINAL APPROVAL
1996-05-14
LATEST ACTION
2023-01-18
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription

Products

TAXOTERE · ReferenceDiscontinued
DOCETAXEL 80MG/4ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
TAXOTERE · ReferencePrescription
DOCETAXEL 160MG/8ML (20MG/ML) · INJECTABLE · INJECTION
TAXOTERE · ReferenceDiscontinued
DOCETAXEL 20MG/ML (20MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
TAXOTERE · ReferenceDiscontinued
DOCETAXEL 40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2023-01-18Labeling · Supplement 86 · standard — Letter ↗AP
2022-04-27Labeling · Supplement 85 · standard — Label ↗AP
2020-05-15Labeling · Supplement 84 · standard — Letter ↗AP
2019-12-17Labeling · Supplement 83 · standard — Label ↗AP
2019-06-06Labeling · Supplement 82 · standard — Label ↗AP
2019-06-06Labeling · Supplement 80 · standard — Label ↗AP
2018-10-05Labeling · Supplement 79 · standard — Label ↗AP
2016-05-17Manufacturing (CMC) · Supplement 74 · priorityAP
2015-12-11Labeling · Supplement 75 · standard — Label ↗AP
2014-11-14Labeling · Supplement 73 · standard — Label ↗AP
2014-05-15Manufacturing (CMC) · Supplement 72 · priorityAP
2013-12-13Labeling · Supplement 71 · standard — Review ↗AP
2013-08-15Manufacturing (CMC) · Supplement 70 · priorityAP
2013-06-26Labeling · Supplement 69 · standard — Label ↗AP
2012-11-21Manufacturing (CMC) · Supplement 68 · priorityAP
2012-04-13Manufacturing (CMC) · Supplement 63 — Label ↗AP
2011-12-15Labeling · Supplement 65 · unknown — Letter ↗AP
2011-09-07Labeling · Supplement 64 · standard — Label ↗AP
2010-08-02Manufacturing (CMC) · Supplement 54 — Review ↗AP
2010-06-03Labeling · Supplement 43 · standard — Review ↗AP
2010-05-13Efficacy · Supplement 59 · priority — Pediatric Written Request ↗AP
2010-04-20Labeling · Supplement 44 · standard — Label ↗AP
2010-04-20Labeling · Supplement 53 · standard — Label ↗AP
2007-09-28Efficacy · Supplement 45 · priority — Label ↗AP
2006-10-17Efficacy · Supplement 39 · priority — Review ↗AP
2006-06-07Labeling · Supplement 36 · standard — Patient Information Sheet ↗AP
2006-03-22Efficacy · Supplement 35 · priority — Label ↗AP
2005-11-05Labeling · Supplement 34 · standard — Letter ↗AP
2005-08-11Labeling · Supplement 33 · standard — Letter ↗AP
2005-01-06Labeling · Supplement 31 · standard — Letter ↗AP
2004-08-18Efficacy · Supplement 29 · priority — Review ↗AP
2004-05-19Efficacy · Supplement 28 · priority — Label ↗AP
2003-04-24Labeling · Supplement 16 · standard — Letter ↗AP
2003-01-30Labeling · Supplement 22 · standard — Letter ↗AP
2002-11-27Efficacy · Supplement 18 · standard — Review ↗AP
2002-07-30Labeling · Supplement 19 · standard — Label ↗AP
2002-07-09Labeling · Supplement 17 · standard — Review ↗AP
2000-11-30Manufacturing (CMC) · Supplement 15 · priorityAP
2000-09-28Manufacturing (CMC) · Supplement 13 · priorityAP
2000-09-28Manufacturing (CMC) · Supplement 14 · priorityAP
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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.

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