FDA.reportPublic FDA data

Application 210251

Type
NDA
Sponsor
GILEAD SCIENCES INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BIKTARVYBICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATETABLET;ORALEQ 50MG BASE;200MG;EQ 25MG BASEYesYes
002BIKTARVYBICTEGRAVIR SODIUM; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATETABLET;ORALEQ 30MG BASE;120MG;EQ 15MG BASEYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-6247Biktarvybictegravir sodium, emtricitabine, and tenofovir alafenamide fumarateA-S Medication SolutionsNDACurrent
61958-2501Biktarvybictegravir sodium, emtricitabine, and tenofovir alafenamide fumarateGilead Sciences, Inc.NDACurrent
61958-2501Biktarvybictegravir sodium, emtricitabine, and tenofovir alafenamide fumarateGilead Sciences, Inc.NDACurrent
61958-2501Biktarvybictegravir sodium, emtricitabine, and tenofovir alafenamide fumarateGilead Sciences, Inc.NDACurrent
61958-2501Biktarvybictegravir sodium, emtricitabine, and tenofovir alafenamide fumarateGilead Sciences, Inc.NDACurrent
61958-2501Biktarvybictegravir sodium, emtricitabine, and tenofovir alafenamide fumarateGilead Sciences, Inc.NDACurrent
61958-2501Biktarvybictegravir sodium, emtricitabine, and tenofovir alafenamide fumarateGilead Sciences, Inc.NDACurrent
61958-2501Biktarvybictegravir sodium, emtricitabine, and tenofovir alafenamide fumarateGilead Sciences, Inc.NDACurrent
61958-2501Biktarvybictegravir sodium, emtricitabine, and tenofovir alafenamide fumarateGilead Sciences, Inc.NDACurrent
61958-2501Biktarvybictegravir sodium, emtricitabine, and tenofovir alafenamide fumarateGilead Sciences, Inc.NDACurrent
61958-2501Biktarvybictegravir sodium, emtricitabine, and tenofovir alafenamide fumarateGilead Sciences, Inc.NDACurrent
61958-2501Biktarvybictegravir sodium, emtricitabine, and tenofovir alafenamide fumarateGilead Sciences, Inc.NDACurrent
61958-2501Biktarvybictegravir sodium, emtricitabine, and tenofovir alafenamide fumarateGilead Sciences, Inc.NDACurrent
61958-2505Biktarvybictegravir sodium, emtricitabine, and tenofovir alafenamide fumarateGilead Sciences, Inc.NDACurrent
61958-2505Biktarvybictegravir sodium, emtricitabine, and tenofovir alafenamide fumarateGilead Sciences, Inc.NDACurrent
70518-3080Biktarvybictegravir sodium, emtricitabine, and tenofovir alafenamide fumarateREMEDYREPACK INC.NDACurrent
70518-3080Biktarvybictegravir sodium, emtricitabine, and tenofovir alafenamide fumarateREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85994SUPPL 2026-05-21
85989SUPPL 2026-05-21
83009SUPPL 2025-08-01
83003SUPPL 2025-07-31
79960SUPPL 2024-10-22
79957SUPPL 2024-10-22
78262SUPPL 2024-04-25
78243SUPPL 2024-04-25
77624SUPPL 2024-02-26
77615SUPPL 2024-02-26
74229SUPPL 2023-05-12
74228SUPPL 2023-05-12
72393SUPPL2022-10-17
72353SUPPL2022-10-17
68979SUPPL2021-10-13
68954SUPPL2021-10-12
68617SUPPL2021-09-14
68593SUPPL2021-09-13
66748SUPPL2021-03-11
66542SUPPL2021-03-05
66459SUPPL2021-03-03
66361SUPPL2021-02-25
66344SUPPL2021-02-24
66209SUPPL2021-02-16
66140SUPPL2021-02-09
66117SUPPL2021-02-08
59591SUPPL2019-08-06
59578SUPPL2019-08-05
59138SUPPL2019-06-20
59122SUPPL2019-06-19
53053ORIG2018-03-19
52499ORIG2018-02-07
52498ORIG2018-02-07
62872ORIG1900-01-01
62871ORIG1900-01-01
62870ORIG1900-01-01