FDA.reportPublic FDA data

Application 208464

Type
NDA
Sponsor
GILEAD SCIENCES INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VEMLIDYTENOFOVIR ALAFENAMIDE FUMARATETABLET;ORALEQ 25MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61958-2301VEMLIDYtenofovir alafenamideGilead Sciences, Inc.NDACurrent
61958-2301VEMLIDYtenofovir alafenamideGilead Sciences, Inc.NDACurrent
61958-2301VEMLIDYtenofovir alafenamideGilead Sciences, Inc.NDACurrent
61958-2301VEMLIDYtenofovir alafenamideGilead Sciences, Inc.NDACurrent
61958-2301VEMLIDYtenofovir alafenamideGilead Sciences, Inc.NDACurrent
61958-2301VEMLIDYtenofovir alafenamideGilead Sciences, Inc.NDACurrent
61958-2301VEMLIDYtenofovir alafenamideGilead Sciences, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78009SUPPL 2024-04-01
78008SUPPL 2024-04-01
78002SUPPL 2024-03-28
78001SUPPL 2024-03-28
73570SUPPL 2023-02-21
72423SUPPL2022-10-19
72405SUPPL2022-10-18
68633SUPPL2021-09-17
68629SUPPL2021-09-17
66679SUPPL2021-03-09
66512SUPPL2021-03-05
64314SUPPL2020-08-19
64312SUPPL2020-08-19
64309SUPPL2020-08-19
64308SUPPL2020-08-19
61849SUPPL2020-02-10
61779SUPPL2020-02-05
57589SUPPL2019-02-13
57436SUPPL2019-02-05
54780SUPPL2018-07-06
50486ORIG2017-11-27
47983SUPPL2017-04-12
47911SUPPL2017-04-10
45896ORIG2016-11-15
45888ORIG2016-11-14