FDA.reportPublic FDA data

Application 021752

Type
NDA
Sponsor
GILEAD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRUVADAEMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATETABLET;ORAL200MG;300MGYesYes
002TRUVADAEMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATETABLET;ORAL100MG;150MGYesNo
003TRUVADAEMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATETABLET;ORAL133MG;200MGYesNo
004TRUVADAEMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATETABLET;ORAL167MG;250MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
35356-070Truvadaemtricitabine and tenofovir disoproxil fumarateLake Erie Medical DBA Quality Care Products LLCNDACurrent
50090-0870Truvadaemtricitabine and tenofovir disoproxil fumarateA-S Medication SolutionsNDACurrent
50090-0870Truvadaemtricitabine and tenofovir disoproxil fumarateA-S Medication SolutionsNDACurrent
50090-0870Truvadaemtricitabine and tenofovir disoproxil fumarateA-S Medication SolutionsNDACurrent
50090-0870Truvadaemtricitabine and tenofovir disoproxil fumarateA-S Medication SolutionsNDACurrent
52959-969Truvadaemtricitabine and tenofovir disoproxil fumarateH.J. Harkins Company, Inc.NDACurrent
53808-0805Truvadaemtricitabine and tenofovir disoproxil fumarateState of Florida DOH Central PharmacyNDACurrent
61919-669TRUVADAemtricitabine and tenofovir disoproxil fumarateDIRECT RXNDACurrent
61919-669TRUVADAemtricitabine and tenofovir disoproxil fumarateDIRECT RXNDACurrent
61958-0701Truvadaemtricitabine and tenofovir disoproxil fumarateGilead Sciences, IncNDACurrent
61958-0701Truvadaemtricitabine and tenofovir disoproxil fumarateGilead Sciences, IncNDACurrent
61958-0701Truvadaemtricitabine and tenofovir disoproxil fumarateGilead Sciences, IncNDACurrent
61958-0701Truvadaemtricitabine and tenofovir disoproxil fumarateGilead Sciences, IncNDACurrent
61958-0701Truvadaemtricitabine and tenofovir disoproxil fumarateGilead Sciences, IncNDACurrent
61958-0703Truvadaemtricitabine and tenofovir disoproxil fumarateGilead Sciences, IncNDACurrent
61958-0703Truvadaemtricitabine and tenofovir disoproxil fumarateGilead Sciences, IncNDACurrent
61958-0703Truvadaemtricitabine and tenofovir disoproxil fumarateGilead Sciences, IncNDACurrent
61958-0703Truvadaemtricitabine and tenofovir disoproxil fumarateGilead Sciences, IncNDACurrent
61958-0703Truvadaemtricitabine and tenofovir disoproxil fumarateGilead Sciences, IncNDACurrent
61958-0704Truvadaemtricitabine and tenofovir disoproxil fumarateGilead Sciences, IncNDACurrent
61958-0704Truvadaemtricitabine and tenofovir disoproxil fumarateGilead Sciences, IncNDACurrent
61958-0704Truvadaemtricitabine and tenofovir disoproxil fumarateGilead Sciences, IncNDACurrent
61958-0704Truvadaemtricitabine and tenofovir disoproxil fumarateGilead Sciences, IncNDACurrent
61958-0704Truvadaemtricitabine and tenofovir disoproxil fumarateGilead Sciences, IncNDACurrent
61958-0705Truvadaemtricitabine and tenofovir disoproxil fumarateGilead Sciences, IncNDACurrent
61958-0705Truvadaemtricitabine and tenofovir disoproxil fumarateGilead Sciences, IncNDACurrent
61958-0705Truvadaemtricitabine and tenofovir disoproxil fumarateGilead Sciences, IncNDACurrent
61958-0705Truvadaemtricitabine and tenofovir disoproxil fumarateGilead Sciences, IncNDACurrent
61958-0705Truvadaemtricitabine and tenofovir disoproxil fumarateGilead Sciences, IncNDACurrent
63629-7581Truvadaemtricitabine and tenofovir disoproxil fumarateBryant Ranch PrepackNDACurrent
63629-7581Truvadaemtricitabine and tenofovir disoproxil fumarateBryant Ranch PrepackNDACurrent
63629-7581Truvadaemtricitabine and tenofovir disoproxil fumarateBryant Ranch PrepackNDACurrent
67296-1237TruvadaTruvadaRedPharm Drug, Inc.NDACurrent
67296-1237TruvadaTruvadaRedPharm Drug, Inc.NDACurrent
67296-1237TruvadaTruvadaRedPharm Drug, Inc.NDACurrent
68071-2112Truvadaemtricitabine and tenofovir disoproxil fumarateNuCare Pharmaceuticals,Inc.NDACurrent
68071-2112Truvadaemtricitabine and tenofovir disoproxil fumarateNuCare Pharmaceuticals,Inc.NDACurrent
69189-0701Truvadaemtricitabine and tenofovir disoproxil fumarateAvera McKennan HospitalNDACurrent
70518-0097Truvadaemtricitabine and tenofovir disoproxil fumarateREMEDYREPACK INC.NDACurrent
70518-0097Truvadaemtricitabine and tenofovir disoproxil fumarateREMEDYREPACK INC.NDACurrent
70518-0097Truvadaemtricitabine and tenofovir disoproxil fumarateREMEDYREPACK INC.NDACurrent
70518-0097Truvadaemtricitabine and tenofovir disoproxil fumarateREMEDYREPACK INC.NDACurrent
70518-0097Truvadaemtricitabine and tenofovir disoproxil fumarateREMEDYREPACK INC.NDACurrent
70518-0097Truvadaemtricitabine and tenofovir disoproxil fumarateREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80160SUPPL 2024-11-05
78305SUPPL 2024-05-03
78314SUPPL 2024-04-30
78313SUPPL 2024-04-30
75720SUPPL 2023-10-13
75708SUPPL 2023-10-12
75707SUPPL 2023-10-12
63684SUPPL2020-06-24
63683SUPPL2020-06-24
63682SUPPL2020-06-24
59204SUPPL2019-07-02
54234SUPPL2018-05-17
54217SUPPL2018-05-16
50051APPL2017-10-12
48690SUPPL2017-06-09
48091SUPPL2017-04-24
48090SUPPL2017-04-24
48089SUPPL2017-04-24
37586SUPPL2016-03-15
28525SUPPL2016-03-14
6124SUPPL2016-02-29
37587SUPPL2016-02-26
6123SUPPL2014-06-19
37585SUPPL2013-12-17
28524SUPPL2013-12-17
37584SUPPL2013-10-25
6122SUPPL2013-10-25
28523SUPPL2013-06-19
16311SUPPL2013-06-17
44648SUPPL2012-08-02
21805SUPPL2012-08-02
37583SUPPL2012-07-18
6121SUPPL2012-07-17
16310SUPPL2012-07-16
6120SUPPL2012-07-16
28522SUPPL2011-07-12
16309SUPPL2011-07-12
6119SUPPL2010-01-21
37582SUPPL2009-11-19
16308SUPPL2008-11-07
6118SUPPL2008-11-07
42298SUPPL2008-07-30
28521SUPPL2008-05-21
16307SUPPL2007-05-29
6117SUPPL2007-05-29
28519SUPPL2006-03-23
16306SUPPL2006-03-10
21804ORIG2006-01-31
28520SUPPL2005-10-11
37581SUPPL2005-10-10
37580SUPPL2005-03-30
28518SUPPL2005-03-30
16305ORIG2004-08-05
6116ORIG2004-08-05
52470ORIG1900-01-01
52469ORIG1900-01-01