← FDA DRUG APPROVALS

FDA BLA · BLA103792

HERCEPTIN

trastuzumab

Sponsor: GENENTECH

APPLICATION
BLA103792
TYPE
BLA
ORIGINAL APPROVAL
1998-09-25
LATEST ACTION
2026-05-18
ROUTE
INTRAVENOUS
DOSAGE FORM
VIAL
MARKETING STATUS
Prescription

Products

HERCEPTINPrescription
TRASTUZUMAB 21MG/ML · VIAL · INTRAVENOUS

Approval history

2026-05-18Labeling · Supplement 5359 · standard — Label ↗AP
2024-06-18Efficacy · Supplement 5354 · standard — Letter ↗AP
2020-08-05Labeling · Supplement 5349 · standard — Letter ↗AP
2018-11-29Labeling · Supplement 5345 · standard — Label ↗AP
2018-10-17Labeling · Supplement 5347 · standard — Label ↗AP
2018-09-20Labeling · Supplement 5344 · standard — Letter ↗AP
2017-04-27Labeling · Supplement 5337 · standard — Label ↗AP
2017-03-27Labeling · Supplement 5339AP
2016-03-17Labeling · Supplement 5330 · standard — Letter ↗AP
2015-04-23Labeling · Supplement 5327 · standard — Label ↗AP
2014-06-30Labeling · Supplement 5318 · standard — Letter ↗AP
2014-06-30Labeling · Supplement 5313 · standard — Letter ↗AP
2014-03-07Efficacy · Supplement 5311 · priority — Label ↗AP
2013-11-20Labeling · Supplement 5305 · standard — Label ↗AP
2012-02-23Manufacturing (CMC) · Supplement 5275 — Review ↗AP
2010-10-29Labeling · Supplement 5256 · standard — Label ↗AP
2010-10-20Efficacy · Supplement 5250 · priority — Label ↗AP
2009-04-08Labeling · Supplement 5213 · standardAP
2008-05-22Efficacy · Supplement 5189 · standard — Review ↗AP
2008-05-22Efficacy · Supplement 5187 · standard — Review ↗AP
2008-01-18Efficacy · Supplement 5175 · standard — Label ↗AP
2006-11-16Efficacy · Supplement 5150 · priority — Label ↗AP
2003-10-16Supplement · Supplement 5046 — Letter ↗AP
2002-08-28Efficacy · Supplement 5008 · standard — Label ↗AP
2001-12-11Efficacy · Supplement 5004 · standard — Label ↗AP
2000-02-09Supplement · Supplement 1005 — Label ↗AP
1998-09-25Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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