FDA.reportPublic FDA data

Application 204671

Type
NDA
Sponsor
GILEAD SCIENCES INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SOVALDISOFOSBUVIRTABLET;ORAL400MGYesYes
002SOVALDISOFOSBUVIRTABLET;ORAL200MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61958-1501SovaldiSOFOSBUVIRGilead Sciences, Inc.NDACurrent
61958-1501SovaldiSOFOSBUVIRGilead Sciences, Inc.NDACurrent
61958-1501SovaldiSOFOSBUVIRGilead Sciences, Inc.NDACurrent
61958-1501SovaldiSOFOSBUVIRGilead Sciences, Inc.NDACurrent
61958-1501SovaldiSOFOSBUVIRGilead Sciences, Inc.NDACurrent
61958-1503SovaldiSOFOSBUVIRGilead Sciences, Inc.NDACurrent
61958-1503SovaldiSOFOSBUVIRGilead Sciences, Inc.NDACurrent
61958-1503SovaldiSOFOSBUVIRGilead Sciences, Inc.NDACurrent
61958-1503SovaldiSOFOSBUVIRGilead Sciences, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80750SUPPL 2024-12-27
80744SUPPL 2024-12-27
64444SUPPL2020-08-28
62076SUPPL2020-03-06
62060SUPPL2020-03-06
60066SUPPL2019-09-20
60062SUPPL2019-09-20
59887SUPPL2019-08-30
59875SUPPL2019-08-29
56179SUPPL2018-10-30
56122SUPPL2018-10-26
50392SUPPL2017-11-13
50374SUPPL2017-11-13
47977SUPPL2017-04-12
47919SUPPL2017-04-10
47215SUPPL2017-02-15
10378SUPPL2015-08-21
19585SUPPL2015-08-20
40410SUPPL2015-03-24
10379SUPPL2015-03-24
40409SUPPL2014-11-20
32578SUPPL2014-11-18
24478ORIG2014-01-27
22961ORIG2014-01-27
19584ORIG2013-12-12
10377ORIG2013-12-09
64085ORIG1900-01-01
64084ORIG1900-01-01
64083ORIG1900-01-01
64082ORIG1900-01-01
51492SUPPL1900-01-01
51491SUPPL1900-01-01