FDA.reportPublic FDA data

Application 021356

Type
NDA
Sponsor
GILEAD SCIENCES INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VIREADTENOFOVIR DISOPROXIL FUMARATETABLET;ORAL300MGYesYes
002VIREADTENOFOVIR DISOPROXIL FUMARATETABLET;ORAL150MGYesNo
003VIREADTENOFOVIR DISOPROXIL FUMARATETABLET;ORAL200MGYesNo
004VIREADTENOFOVIR DISOPROXIL FUMARATETABLET;ORAL250MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-0754VireadTENOFOVIR DISOPROXIL FUMARATEA-S Medication SolutionsNDACurrent
50090-0754VireadTENOFOVIR DISOPROXIL FUMARATEA-S Medication SolutionsNDACurrent
53808-0810Vireadtenofovir disoproxil fumarateState of Florida DOH Central PharmacyNDACurrent
61958-0401VireadTENOFOVIR DISOPROXIL FUMARATEGilead Sciences, Inc.NDACurrent
61958-0401VireadTENOFOVIR DISOPROXIL FUMARATEGilead Sciences, Inc.NDACurrent
61958-0401VireadTENOFOVIR DISOPROXIL FUMARATEGilead Sciences, Inc.NDACurrent
61958-0401VireadTENOFOVIR DISOPROXIL FUMARATEGilead Sciences, Inc.NDACurrent
61958-0404VireadTENOFOVIR DISOPROXIL FUMARATEGilead Sciences, Inc.NDACurrent
61958-0404VireadTENOFOVIR DISOPROXIL FUMARATEGilead Sciences, Inc.NDACurrent
61958-0404VireadTENOFOVIR DISOPROXIL FUMARATEGilead Sciences, Inc.NDACurrent
61958-0404VireadTENOFOVIR DISOPROXIL FUMARATEGilead Sciences, Inc.NDACurrent
61958-0405VireadTENOFOVIR DISOPROXIL FUMARATEGilead Sciences, Inc.NDACurrent
61958-0405VireadTENOFOVIR DISOPROXIL FUMARATEGilead Sciences, Inc.NDACurrent
61958-0405VireadTENOFOVIR DISOPROXIL FUMARATEGilead Sciences, Inc.NDACurrent
61958-0405VireadTENOFOVIR DISOPROXIL FUMARATEGilead Sciences, Inc.NDACurrent
61958-0406VireadTENOFOVIR DISOPROXIL FUMARATEGilead Sciences, Inc.NDACurrent
61958-0406VireadTENOFOVIR DISOPROXIL FUMARATEGilead Sciences, Inc.NDACurrent
61958-0406VireadTENOFOVIR DISOPROXIL FUMARATEGilead Sciences, Inc.NDACurrent
61958-0406VireadTENOFOVIR DISOPROXIL FUMARATEGilead Sciences, Inc.NDACurrent
69189-0401VireadTENOFOVIR DISOPROXIL FUMARATEAvera McKennan HospitalNDACurrent
70518-0546VireadTENOFOVIR DISOPROXIL FUMARATEREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
58410SUPPL2019-04-25
58393SUPPL2019-04-24
56862SUPPL2018-12-20
56706SUPPL2018-12-12
55069SUPPL2018-07-31
55059SUPPL2018-07-30
47982SUPPL2017-04-12
47913SUPPL2017-04-10
27578SUPPL2016-02-18
15279SUPPL2016-02-18
36744SUPPL2015-06-04
27577SUPPL2015-06-02
36743SUPPL2013-10-25
27576SUPPL2013-10-25
15278SUPPL2013-07-30
5151SUPPL2013-07-26
36742SUPPL2013-04-09
27575SUPPL2013-04-03
5150SUPPL2012-08-20
15277SUPPL2012-08-17
5149SUPPL2012-08-09
36741SUPPL2012-08-08
15275SUPPL2012-02-01
27573SUPPL2012-01-20
27574SUPPL2011-11-22
15276SUPPL2011-11-22
5148SUPPL2011-09-21
36740SUPPL2011-09-20
52368SUPPL2011-09-06
52367SUPPL2011-09-06
52366SUPPL2011-09-06
52365SUPPL2011-09-06
52364SUPPL2011-09-06
52363SUPPL2011-09-06
27572SUPPL2010-10-19
15274SUPPL2010-10-19
5147SUPPL2010-10-13
15273SUPPL2010-10-12
27571SUPPL2010-03-29
36739SUPPL2010-03-26
5146SUPPL2010-01-25
15272SUPPL2009-11-13
5145SUPPL2009-11-10
15271SUPPL2009-10-14
36738SUPPL2008-11-07
5144SUPPL2008-11-06
15270SUPPL2008-08-29
5143SUPPL2008-08-13
27570SUPPL2008-05-21
15269SUPPL2007-05-29
5142SUPPL2007-05-29
5140SUPPL2006-03-23
36736SUPPL2006-03-10
36737SUPPL2005-12-05
5141SUPPL2005-12-05
15268SUPPL2005-05-17
5139SUPPL2005-05-17
15267SUPPL2004-07-07
5138SUPPL2004-07-06
15266SUPPL2003-12-01
5137SUPPL2003-11-25
27569SUPPL2003-10-16
15265SUPPL2003-10-16
27568SUPPL2003-08-28
15264SUPPL2003-08-28
15263SUPPL2002-12-02
5136SUPPL2002-12-02
36735ORIG2001-10-26
21613ORIG2001-10-26
5135ORIG2001-10-26
63282SUPPL1900-01-01
63281SUPPL1900-01-01
63280SUPPL1900-01-01
52374ORIG1900-01-01
52373ORIG1900-01-01
52372ORIG1900-01-01
52371ORIG1900-01-01
52370ORIG1900-01-01
52369ORIG1900-01-01
51678ORIG1900-01-01
51677ORIG1900-01-01
51676ORIG1900-01-01