FDA.reportPublic FDA data

Application 208351

Type
NDA
Sponsor
GILEAD SCIENCES INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ODEFSEYEMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR ALAFENAMIDE FUMARATETABLET;ORAL200MG;EQ 25MG BASE;EQ 25MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-2340ODEFSEYemtricitabine, rilpivirine, and tenofovir alafenamideA-S Medication SolutionsNDACurrent
61958-2101ODEFSEYemtricitabine, rilpivirine hydrochloride, and tenofovir alafenamideGilead Sciences, Inc.NDACurrent
61958-2101ODEFSEYemtricitabine, rilpivirine hydrochloride, and tenofovir alafenamideGilead Sciences, Inc.NDACurrent
61958-2101ODEFSEYemtricitabine, rilpivirine hydrochloride, and tenofovir alafenamideGilead Sciences, Inc.NDACurrent
61958-2101ODEFSEYemtricitabine, rilpivirine hydrochloride, and tenofovir alafenamideGilead Sciences, Inc.NDACurrent
61958-2101ODEFSEYemtricitabine, rilpivirine hydrochloride, and tenofovir alafenamideGilead Sciences, Inc.NDACurrent
70518-0695ODEFSEYemtricitabine, rilpivirine hydrochloride, and tenofovir alafenamideREMEDYREPACK INC.NDACurrent
70518-0695ODEFSEYemtricitabine, rilpivirine hydrochloride, and tenofovir alafenamideREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81303SUPPL 2025-02-21
81302SUPPL 2025-02-21
81294SUPPL 2025-02-20
81293SUPPL 2025-02-20
68615SUPPL2021-09-14
68597SUPPL2021-09-13
66544SUPPL2021-03-05
66513SUPPL2021-03-05
61164SUPPL2019-12-05
61145SUPPL2019-12-04
56231SUPPL2018-11-01
56220SUPPL2018-10-31
49510SUPPL2017-08-22
49509SUPPL2017-08-22
49503SUPPL2017-08-22
49502SUPPL2017-08-22
47986SUPPL2017-04-12
47907SUPPL2017-04-10
46008ORIG2016-12-02
32907ORIG2016-03-03
19992ORIG2016-03-03
52461ORIG1900-01-01
52460ORIG1900-01-01
52459ORIG1900-01-01
52458ORIG1900-01-01