FDA.reportPublic FDA data

Application 022577

Type
NDA
Sponsor
GILEAD SCIENCES INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VIREADTENOFOVIR DISOPROXIL FUMARATEPOWDER;ORAL40MG/SCOOPFULYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61958-0403VireadTENOFOVIR DISOPROXIL FUMARATEGilead Sciences, Inc.NDACurrent
61958-0403VireadTENOFOVIR DISOPROXIL FUMARATEGilead Sciences, Inc.NDACurrent
61958-0403VireadTENOFOVIR DISOPROXIL FUMARATEGilead Sciences, Inc.NDACurrent
61958-0403VireadTENOFOVIR DISOPROXIL FUMARATEGilead Sciences, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
58411SUPPL2019-04-25
58394SUPPL2019-04-24
56865SUPPL2018-12-20
56707SUPPL2018-12-12
55070SUPPL2018-07-31
47981SUPPL2017-04-12
47912SUPPL2017-04-10
17740SUPPL2016-02-18
7565SUPPL2016-02-18
38861SUPPL2015-06-04
7564SUPPL2015-06-02
29882SUPPL2013-10-25
17739SUPPL2013-10-25
17738SUPPL2013-07-30
29881SUPPL2013-07-26
38860SUPPL2013-04-09
7563SUPPL2013-04-03
44783ORIG2012-11-13
22064ORIG2012-11-13
29880SUPPL2012-08-20
17737SUPPL2012-08-17
7562SUPPL2012-08-09
17736SUPPL2012-08-08
17735ORIG2012-01-31
7561ORIG2012-01-31
68942ORIG1900-01-01
68941ORIG1900-01-01
68940ORIG1900-01-01