FDA.reportPublic FDA data

Application 020509

Type
NDA
Sponsor
LILLY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GEMZARGEMCITABINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 200MG BASE/VIALYesYes
002GEMZARGEMCITABINE HYDROCHLORIDEINJECTABLE;INJECTIONEQ 1GM BASE/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0002-7501GemzarGemcitabine hydrochlorideEli Lilly and CompanyNDACurrent
0002-7501GemzarGemcitabine hydrochlorideEli Lilly and CompanyNDACurrent
0002-7501GemzarGemcitabine hydrochlorideEli Lilly and CompanyNDACurrent
0002-7502GemzarGemcitabine hydrochlorideEli Lilly and CompanyNDACurrent
0002-7502GemzarGemcitabine hydrochlorideEli Lilly and CompanyNDACurrent
0002-7502GemzarGemcitabine hydrochlorideEli Lilly and CompanyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
58766SUPPL2019-05-17
58722SUPPL2019-05-15
57656ORIG2019-02-15
56696SUPPL2018-12-10
56555SUPPL2018-11-23
54666SUPPL2018-06-21
49803SUPPL2017-09-19
49735SUPPL2017-09-14
12661SUPPL2015-10-13
2632SUPPL2014-06-12
34741SUPPL2014-05-12
25080SUPPL2014-05-12
34740SUPPL2013-05-08
12660SUPPL2011-02-09
12659SUPPL2010-03-26
25079SUPPL2010-03-24
20689SUPPL2008-02-19
41404SUPPL2007-11-19
25078SUPPL2006-07-21
2631SUPPL2006-04-07
34739SUPPL2005-04-28
25077SUPPL2005-04-28
12658SUPPL2005-04-28
2630SUPPL2005-04-28
25076SUPPL2005-04-07
2629SUPPL2004-05-26
12657SUPPL2004-05-19
12656SUPPL2003-03-07
2628SUPPL2002-05-01
34738SUPPL1998-08-25
2627SUPPL1998-08-25
66910ORIG1900-01-01
51964SUPPL1900-01-01