FDA.reportPublic FDA data

Application 021896

Type
NDA
Sponsor
GILEAD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EMTRIVAEMTRICITABINESOLUTION;ORAL10MG/MLYesYes
002EMTRIVAEMTRICITABINESOLUTION; ORAL10MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61958-0602EmtrivaEMTRICITABINEGilead Sciences, Inc.NDACurrent
61958-0602EmtrivaEMTRICITABINEGilead Sciences, Inc.NDACurrent
61958-0602EmtrivaEMTRICITABINEGilead Sciences, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57149SUPPL2019-01-09
56835SUPPL2018-12-20
47914SUPPL2017-04-10
16535SUPPL2013-04-09
6405SUPPL2013-04-03
28804SUPPL2012-07-25
16534SUPPL2012-07-24
16533SUPPL2011-11-29
28803SUPPL2011-11-22
6404SUPPL2008-05-21
37839SUPPL2008-04-16
28802SUPPL2008-04-09
21862ORIG2007-07-18
6403SUPPL2007-01-08
16532SUPPL2006-12-28
28801ORIG2005-10-20
37838ORIG2005-09-30
51845ORIG1900-01-01
51844ORIG1900-01-01
51843ORIG1900-01-01
51842ORIG1900-01-01