Gemzar

NDA 20509, held by Lilly. Gemcitabine Hydrochloride.

As of Nov 13, 2026, NDA 20509 (Gemzar), held by Lilly, was first approved by FDA on May 15, 1996, with 33 approved supplements and 0 published complete response letters.

First approved: May 15, 1996
Review: Priority
Supplements approved: 33
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 34 submissions below


Jul 14, 2006	Supplement 39Efficacy (new indication or use)	Approved	Letter
Apr 26, 2005	Supplement 33Efficacy (new indication or use) · Priority review	Approved	Review Letter Label Pediatric Written Request
May 19, 2004	Supplement 29Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Aug 25, 1998	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 15, 1996	Original applicationNew molecular entity · Priority review	Approved	Review Pediatric Medical Review

Products

2 strengths and forms


GemzarEQ 200MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Gemcitabine Hydrochloride	DiscontinuedReference drug
GemzarEQ 1GM BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons · injectable;injection	Gemcitabine Hydrochloride	DiscontinuedReference drug

All 34 submissions, including labeling and manufacturing supplements


May 14, 2019	Supplement 82Labeling · Standard review	Approved	Label Letter
Nov 20, 2018	Supplement 81Labeling · Standard review	Approved	Letter Label
Jun 8, 2018	Supplement 80Labeling · Standard review	Approved	Label
Sep 13, 2017	Supplement 79Labeling · Standard review	Approved	Letter Label
Aug 11, 2014	Supplement 76Manufacturing · Priority review	Approved	None posted
Jun 10, 2014	Supplement 75Labeling · Standard review	Approved	Label Letter
May 8, 2014	Supplement 77Labeling	Approved	Letter Label
May 7, 2013	Supplement 72Labeling · Standard review	Approved	Label
Feb 4, 2011	Supplement 69Labeling	Approved	Label
Mar 19, 2010	Supplement 64Labeling · Standard review	Approved	Label Letter
Jul 14, 2006	Supplement 39Efficacy (new indication or use)	Approved	Letter
Apr 5, 2006	Supplement 37Labeling · Standard review	Approved	Letter
Apr 26, 2005	Supplement 33Efficacy (new indication or use) · Priority review	Approved	Review Letter Label Pediatric Written Request
Apr 20, 2005	Supplement 32Labeling · Standard review	Approved	Letter Label
May 19, 2004	Supplement 29Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Jan 6, 2003	Supplement 13Labeling · Standard review	Approved	Letter Label
Nov 13, 2002	Supplement 22Manufacturing · Priority review	Approved	None posted
May 1, 2002	Supplement 21Manufacturing · Priority review	Approved	Letter
May 18, 2001	Supplement 20Manufacturing · Priority review	Approved	None posted
Jan 4, 2001	Supplement 18Manufacturing · Priority review	Approved	None posted
Nov 1, 2000	Supplement 19Manufacturing · Priority review	Approved	None posted
Jun 23, 2000	Supplement 10Labeling · Standard review	Approved	None posted
Jun 22, 2000	Supplement 16Manufacturing · Priority review	Approved	None posted
Jun 9, 2000	Supplement 17Manufacturing · Priority review	Approved	None posted
Mar 3, 2000	Supplement 14Manufacturing · Priority review	Approved	None posted
Nov 23, 1998	Supplement 11Manufacturing · Priority review	Approved	None posted
Oct 16, 1998	Supplement 7Manufacturing · Priority review	Approved	None posted
Aug 25, 1998	Supplement 5Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jan 23, 1998	Supplement 6Manufacturing · Priority review	Approved	None posted
Oct 10, 1997	Supplement 3Manufacturing · Priority review	Approved	None posted
Sep 18, 1997	Supplement 4Labeling · Standard review	Approved	None posted
Apr 11, 1997	Supplement 2Manufacturing · Priority review	Approved	None posted
Feb 5, 1997	Supplement 1Manufacturing · Priority review	Approved	None posted
May 15, 1996	Original applicationNew molecular entity · Priority review	Approved	Review Pediatric Medical Review

Identifiers

Application: NDA 20509
Drugs@FDA: Overview at FDA
Company: Lilly

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters