FDA.reportPublic FDA data

Application 207561

Type
NDA
Sponsor
GILEAD SCIENCES INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GENVOYACOBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATETABLET;ORAL150MG;150MG;200MG;EQ 10MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-2279Genvoyaelvitegravir, cobicistat, emtricitabine, and tenofovir alafenamideA-S Medication SolutionsNDACurrent
61958-1901Genvoyaelvitegravir, cobicistat, emtricitabine, and tenofovir alafenamideGilead Sciences, Inc.NDACurrent
61958-1901Genvoyaelvitegravir, cobicistat, emtricitabine, and tenofovir alafenamideGilead Sciences, Inc.NDACurrent
61958-1901Genvoyaelvitegravir, cobicistat, emtricitabine, and tenofovir alafenamideGilead Sciences, Inc.NDACurrent
61958-1901Genvoyaelvitegravir, cobicistat, emtricitabine, and tenofovir alafenamideGilead Sciences, Inc.NDACurrent
61958-1901Genvoyaelvitegravir, cobicistat, emtricitabine, and tenofovir alafenamideGilead Sciences, Inc.NDACurrent
61958-1901Genvoyaelvitegravir, cobicistat, emtricitabine, and tenofovir alafenamideGilead Sciences, Inc.NDACurrent
70518-0568Genvoyaelvitegravir, cobicistat, emtricitabine, and tenofovir alafenamideREMEDYREPACK INC.NDACurrent
70518-0568Genvoyaelvitegravir, cobicistat, emtricitabine, and tenofovir alafenamideREMEDYREPACK INC.NDACurrent
70518-0568Genvoyaelvitegravir, cobicistat, emtricitabine, and tenofovir alafenamideREMEDYREPACK INC.NDACurrent
70518-0568Genvoyaelvitegravir, cobicistat, emtricitabine, and tenofovir alafenamideREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69831SUPPL2022-01-11
69826SUPPL2022-01-11
68623SUPPL2021-09-15
68596SUPPL2021-09-13
66608SUPPL2021-03-08
66546SUPPL2021-03-05
65589SUPPL2020-12-15
65490SUPPL2020-12-03
58041SUPPL2019-03-19
58039SUPPL2019-03-19
56837SUPPL2018-12-20
56717SUPPL2018-12-12
56472SUPPL2018-11-15
56282SUPPL2018-11-06
55094SUPPL2018-08-03
55072SUPPL2018-08-02
50508SUPPL2017-11-27
50477SUPPL2017-11-24
49877SUPPL2017-09-28
49860SUPPL2017-09-26
49488SUPPL2017-08-21
49455SUPPL2017-08-17
47984SUPPL2017-04-12
47909SUPPL2017-04-10
47255SUPPL2017-02-16
47254SUPPL2017-02-16
46100SUPPL2016-12-08
46093SUPPL2016-12-08
45280SUPPL2016-09-19
45312SUPPL2016-09-15
45248SUPPL2016-09-09
45242SUPPL2016-09-08
40589SUPPL2016-03-14
32856SUPPL2016-03-10
44960ORIG2015-12-08
23037ORIG2015-12-08
19964ORIG2015-11-12
32855ORIG2015-11-09
54153SUPPL1900-01-01
52454SUPPL1900-01-01
52453ORIG1900-01-01
52452ORIG1900-01-01
52451ORIG1900-01-01