← FDA DRUG APPROVALS

FDA NDA · NDA022059

TYKERB

lapatinib

Sponsor: NOVARTIS

APPLICATION
NDA022059
TYPE
NDA
ORIGINAL APPROVAL
2007-03-13
LATEST ACTION
2022-03-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

TYKERB · ReferencePrescription
LAPATINIB DITOSYLATE EQ 250MG BASE · TABLET · ORAL

Approval history

2022-03-27Labeling · Supplement 31 · standard — Label ↗AP
2018-12-06Efficacy · Supplement 23 · standard — Label ↗AP
2018-12-06Labeling · Supplement 24 · standard — Label ↗AP
2017-04-06Labeling · Supplement 22 · standard — Label ↗AP
2015-03-31Labeling · Supplement 20 · standard — Label ↗AP
2014-12-22Labeling · Supplement 21 · 901 required — Label ↗AP
2013-10-18Efficacy · Supplement 17 · standard — Label ↗AP
2013-10-18Efficacy · Supplement 16 · standard — Label ↗AP
2013-06-21Labeling · Supplement 15 · standard — Label ↗AP
2013-06-21Labeling · Supplement 18 · standard — Label ↗AP
2012-03-02Labeling · Supplement 13 · unknown — Label ↗AP
2011-08-12Labeling · Supplement 11 · unknown — Label ↗AP
2011-08-12Labeling · Supplement 12 · unknown — Label ↗AP
2010-01-29Efficacy · Supplement 7 · standard — Review ↗AP
2010-01-29Labeling · Supplement 3 · standard — Letter ↗AP
2010-01-29Labeling · Supplement 6 · standard — Label ↗AP
2008-07-07Labeling · Supplement 4 · standard — Label ↗AP
2007-08-20Labeling · Supplement 2 · standard — Label ↗AP
2007-04-27Labeling · Supplement 1 · standard — Letter ↗AP
2007-03-13Type 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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