FDA.reportPublic FDA data

Application 205858

Type
NDA
Sponsor
GILEAD SCIENCES INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZYDELIGIDELALISIBTABLET;ORAL100MGYesNo
002ZYDELIGIDELALISIBTABLET;ORAL150MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61958-1701ZydeligidelalisibGilead Sciences, Inc.NDACurrent
61958-1701ZydeligidelalisibGilead Sciences, Inc.NDACurrent
61958-1701ZydeligidelalisibGilead Sciences, Inc.NDACurrent
61958-1702ZydeligidelalisibGilead Sciences, Inc.NDACurrent
61958-1702ZydeligidelalisibGilead Sciences, Inc.NDACurrent
61958-1702ZydeligidelalisibGilead Sciences, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71527SUPPL2022-07-07
70483SUPPL2022-03-11
70210SUPPL2022-02-22
70198SUPPL2022-02-22
70197SUPPL2022-02-22
64963SUPPL2020-10-21
64955SUPPL2020-10-21
64954SUPPL2020-10-21
57113SUPPL2019-01-30
55897SUPPL2018-10-11
53502SUPPL2018-03-28
52518SUPPL2018-02-08
52509SUPPL2018-02-08
52400SUPPL2018-02-05
52399SUPPL2018-02-05
52127SUPPL2018-01-30
52083SUPPL2018-01-30
50567SUPPL2017-12-01
50529SUPPL2017-11-30
46678SUPPL2017-01-05
45411SUPPL2016-09-29
45362SUPPL2016-09-22
44935ORIG2015-02-06
23007ORIG2015-02-06
44599ORIG2014-08-01
10520ORIG2014-07-24
40518ORIG2014-07-23