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FDA NDA · NDA020509

GEMZAR

Sponsor: LILLY

APPLICATION
NDA020509
TYPE
NDA
ORIGINAL APPROVAL
1996-05-15
LATEST ACTION
2019-05-14
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

GEMZAR · ReferenceDiscontinued
GEMCITABINE HYDROCHLORIDE EQ 200MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
GEMZAR · ReferenceDiscontinued
GEMCITABINE HYDROCHLORIDE EQ 1GM BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2019-05-14Labeling · Supplement 82 · standard — Letter ↗AP
2018-11-20Labeling · Supplement 81 · standard — Label ↗AP
2018-06-08Labeling · Supplement 80 · standard — Label ↗AP
2017-09-13Labeling · Supplement 79 · standard — Label ↗AP
2014-08-11Manufacturing (CMC) · Supplement 76 · priorityAP
2014-06-10Labeling · Supplement 75 · standard — Label ↗AP
2014-05-08Labeling · Supplement 77 · 901 required — Letter ↗AP
2013-05-07Labeling · Supplement 72 · standard — Label ↗AP
2011-02-04Labeling · Supplement 69 · unknown — Label ↗AP
2010-03-19Labeling · Supplement 64 · standard — Label ↗AP
2006-07-14Efficacy · Supplement 39 · unknown — Letter ↗AP
2006-04-05Labeling · Supplement 37 · standard — Letter ↗AP
2005-04-26Efficacy · Supplement 33 · priority — Pediatric Written Request ↗AP
2005-04-20Labeling · Supplement 32 · standard — Letter ↗AP
2004-05-19Efficacy · Supplement 29 · priority — Review ↗AP
2003-01-06Labeling · Supplement 13 · standard — Label ↗AP
2002-11-13Manufacturing (CMC) · Supplement 22 · priorityAP
2002-05-01Manufacturing (CMC) · Supplement 21 · priority — Letter ↗AP
2001-05-18Manufacturing (CMC) · Supplement 20 · priorityAP
2001-01-04Manufacturing (CMC) · Supplement 18 · priorityAP
2000-11-01Manufacturing (CMC) · Supplement 19 · priorityAP
2000-06-23Labeling · Supplement 10 · standardAP
2000-06-22Manufacturing (CMC) · Supplement 16 · priorityAP
2000-06-09Manufacturing (CMC) · Supplement 17 · priorityAP
2000-03-03Manufacturing (CMC) · Supplement 14 · priorityAP
1998-11-23Manufacturing (CMC) · Supplement 11 · priorityAP
1998-10-16Manufacturing (CMC) · Supplement 7 · priorityAP
1998-08-25Efficacy · Supplement 5 · standard — Letter ↗AP
1998-01-23Manufacturing (CMC) · Supplement 6 · priorityAP
1997-10-10Manufacturing (CMC) · Supplement 3 · priorityAP
1997-09-18Labeling · Supplement 4 · standardAP
1997-04-11Manufacturing (CMC) · Supplement 2 · priorityAP
1997-02-05Manufacturing (CMC) · Supplement 1 · priorityAP
1996-05-15Type 1 - New Molecular Entity · Original · priority — Review ↗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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