← FDA DRUG APPROVALS

FDA NDA · NDA021743

TARCEVA

Sponsor: OSI PHARMS

APPLICATION
NDA021743
TYPE
NDA
ORIGINAL APPROVAL
2004-11-18
LATEST ACTION
2016-10-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

TARCEVA · ReferenceDiscontinued
ERLOTINIB HYDROCHLORIDE EQ 150MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
TARCEVA · ReferenceDiscontinued
ERLOTINIB HYDROCHLORIDE EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
TARCEVA · ReferenceDiscontinued
ERLOTINIB HYDROCHLORIDE EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2016-10-18Efficacy · Supplement 25 · standard — Label ↗AP
2016-09-28Labeling · Supplement 26 · standard — Letter ↗AP
2016-06-01Efficacy · Supplement 27 · standard — Letter ↗AP
2016-05-20Efficacy · Supplement 23 · standard — Label ↗AP
2016-03-15Manufacturing (CMC) · Supplement 24 · priorityAP
2015-07-06Manufacturing (CMC) · Supplement 22 · priorityAP
2015-04-27Efficacy · Supplement 21 · priority — Pediatric Written Request ↗AP
2014-04-14Labeling · Supplement 19 · standard — Label ↗AP
2013-05-14Efficacy · Supplement 18 · priority — Label ↗AP
2012-04-17Labeling · Supplement 17 · unknown — Letter ↗AP
2010-04-16Efficacy · Supplement 16 · standard — Letter ↗AP
2010-04-16Labeling · Supplement 14 · standard — Letter ↗AP
2009-04-27Labeling · Supplement 15 · standard — Label ↗AP
2008-09-19Efficacy · Supplement 11 · unknown — Label ↗AP
2008-09-12Labeling · Supplement 8 · priority — Letter ↗AP
2008-09-12Labeling · Supplement 10 · standard — Letter ↗AP
2007-04-27Labeling · Supplement 7 · standard — Letter ↗AP
2005-11-02Efficacy · Supplement 3 · priority — Label ↗AP
2004-11-18Type 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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