FDA.reportPublic FDA data

Application 021449

Type
NDA
Sponsor
GILEAD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HEPSERAADEFOVIR DIPIVOXILTABLET;ORAL10MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
46014-0501HepseraAdefovir DipivoxilExcella GmbHNDACurrent
61958-0501Hepseraadefovir dipivoxilGilead Sciences, Inc.NDACurrent
61958-0501Hepseraadefovir dipivoxilGilead Sciences, Inc.NDACurrent
61958-0501Hepseraadefovir dipivoxilGilead Sciences, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57055SUPPL2019-02-13
57100SUPPL2019-01-02
36970SUPPL2012-11-30
5424SUPPL2012-11-30
27831SUPPL2012-03-02
15510SUPPL2012-03-01
5423SUPPL2009-11-25
36969SUPPL2009-10-21
5422SUPPL2008-01-09
15509SUPPL2007-12-27
27829SUPPL2006-10-23
15508SUPPL2006-10-23
27830SUPPL2006-09-25
36968SUPPL2006-09-21
36967SUPPL2006-05-02
27828SUPPL2006-05-02
15507SUPPL2004-08-25
5421SUPPL2004-08-25
21668ORIG2004-06-07
15506ORIG2002-09-20
5420ORIG2002-09-20
53159ORIG1900-01-01
53158ORIG1900-01-01
53157ORIG1900-01-01