FDA.reportPublic FDA data

Application 208215

Type
NDA
Sponsor
GILEAD SCIENCES INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DESCOVYEMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATETABLET;ORAL200MG;EQ 25MG BASEYesYes
002DESCOVYEMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATETABLET;ORAL120MG;EQ 15MG BASEYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61958-2002DESCOVYemtricitabine and tenofovir alafenamideGilead Sciences, Inc.NDACurrent
61958-2002DESCOVYemtricitabine and tenofovir alafenamideGilead Sciences, Inc.NDACurrent
61958-2002DESCOVYemtricitabine and tenofovir alafenamideGilead Sciences, Inc.NDACurrent
61958-2002DESCOVYemtricitabine and tenofovir alafenamideGilead Sciences, Inc.NDACurrent
61958-2002DESCOVYemtricitabine and tenofovir alafenamideGilead Sciences, Inc.NDACurrent
61958-2002DESCOVYemtricitabine and tenofovir alafenamideGilead Sciences, Inc.NDACurrent
61958-2002DESCOVYemtricitabine and tenofovir alafenamideGilead Sciences, Inc.NDACurrent
61958-2002DESCOVYemtricitabine and tenofovir alafenamideGilead Sciences, Inc.NDACurrent
61958-2005DESCOVYemtricitabine and tenofovir alafenamideGilead Sciences, Inc.NDACurrent
70518-0230DESCOVYemtricitabine and tenofovir alafenamide fumarateREMEDYREPACK INC.NDACurrent
70518-0230DESCOVYemtricitabine and tenofovir alafenamide fumarateREMEDYREPACK INC.NDACurrent
70518-0230DESCOVYemtricitabine and tenofovir alafenamide fumarateREMEDYREPACK INC.NDACurrent
70518-0230DESCOVYemtricitabine and tenofovir alafenamide fumarateREMEDYREPACK INC.NDACurrent
70518-0230DESCOVYemtricitabine and tenofovir alafenamide fumarateREMEDYREPACK INC.NDACurrent
70518-0230DESCOVYemtricitabine and tenofovir alafenamide fumarateREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82666SUPPL 2025-06-25
82665SUPPL 2025-06-25
82634SUPPL 2025-06-23
82633SUPPL 2025-06-23
82632SUPPL 2025-06-23
69840SUPPL2022-01-12
69825SUPPL2022-01-11
68642SUPPL2021-09-20
68641SUPPL2021-09-20
68634SUPPL2021-09-17
67177SUPPL2021-04-26
67174SUPPL2021-04-26
66751SUPPL2021-03-11
66501SUPPL2021-03-05
61232SUPPL2019-12-11
61167SUPPL2019-12-05
61166SUPPL2019-12-05
61144SUPPL2019-12-04
60229SUPPL2019-10-04
60217SUPPL2019-10-04
49907SUPPL2017-10-02
49884SUPPL2017-09-29
47910SUPPL2017-04-10
46606ORIG2016-12-30
46605ORIG2016-12-30
32898ORIG2016-04-13
40625ORIG2016-04-12
62980SUPPL1900-01-01
53533ORIG1900-01-01
52468SUPPL1900-01-01
52466ORIG1900-01-01
52465ORIG1900-01-01
52464ORIG1900-01-01
52463ORIG1900-01-01
52462ORIG1900-01-01