FDA.reportPublic FDA data

Application 021500

Type
NDA
Sponsor
GILEAD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EMTRIVAEMTRICITABINECAPSULE;ORAL200MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
46014-0601EmtrivaemtricitabineExcella GmbHNDACurrent
53808-0801EmtrivaemtricitabineState of Florida DOH Central PharmacyNDACurrent
61958-0601EmtrivaEMTRICITABINEGilead Sciences, Inc.NDACurrent
61958-0601EmtrivaEMTRICITABINEGilead Sciences, Inc.NDACurrent
61958-0601EmtrivaEMTRICITABINEGilead Sciences, Inc.NDACurrent
70518-1847EmtrivaEMTRICITABINEREMEDYREPACK INC.NDACurrent
70518-1847EmtrivaEMTRICITABINEREMEDYREPACK INC.NDACurrent
70518-1847EmtrivaEMTRICITABINEREMEDYREPACK INC.NDACurrent
70518-1847EmtrivaEMTRICITABINEREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57148SUPPL2019-01-09
56836SUPPL2018-12-20
47915SUPPL2017-04-10
15607SUPPL2013-04-09
5554SUPPL2013-04-03
27935SUPPL2012-07-25
15606SUPPL2012-07-23
37078SUPPL2011-11-29
5553SUPPL2011-11-22
5552SUPPL2008-05-21
15605SUPPL2008-04-16
5551SUPPL2008-04-09
5550SUPPL2007-01-08
15604SUPPL2006-12-28
15603SUPPL2005-12-13
5549SUPPL2005-12-13
5548SUPPL2005-06-14
42194ORIG2003-09-09
37077ORIG2003-07-08
27934ORIG2003-07-08