FDA.reportPublic FDA data

Application 021797

Type
NDA
Sponsor
BRISTOL MYERS SQUIBB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BARACLUDEENTECAVIRTABLET;ORAL0.5MGYesNo
002BARACLUDEENTECAVIRTABLET;ORAL1MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0003-1611BARACLUDEentecavirE.R. Squibb & Sons, L.L.C.NDACurrent
0003-1611BARACLUDEentecavirE.R. Squibb & Sons, L.L.CNDACurrent
0003-1611BARACLUDEentecavirE.R. Squibb & Sons, L.L.C.NDACurrent
0003-1611BARACLUDEentecavirE.R. Squibb & Sons, L.L.C.NDACurrent
0003-1612BARACLUDEentecavirE.R. Squibb & Sons, L.L.C.NDACurrent
0003-1612BARACLUDEentecavirE.R. Squibb & Sons, L.L.CNDACurrent
0003-1612BARACLUDEentecavirE.R. Squibb & Sons, L.L.C.NDACurrent
0003-1612BARACLUDEentecavirE.R. Squibb & Sons, L.L.C.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
60972SUPPL2019-11-19
60812SUPPL2019-11-12
56993SUPPL2018-12-21
56952SUPPL2018-12-21
54813SUPPL2018-07-07
54710SUPPL2018-06-27
37668SUPPL2014-03-25
6206SUPPL2014-03-21
37667SUPPL2013-12-23
6205SUPPL2013-12-20
51711SUPPL2013-05-31
37666SUPPL2012-10-15
28616SUPPL2012-10-15
16383SUPPL2012-10-15
6204SUPPL2012-10-15
6203SUPPL2011-01-04
37665SUPPL2010-12-28
37664SUPPL2010-10-29
51707SUPPL2010-06-28
37662SUPPL2009-07-24
6202SUPPL2009-07-22
37663SUPPL2009-03-17
28615SUPPL2009-02-27
16382SUPPL2008-08-13
28613SUPPL2008-07-31
28614SUPPL2008-06-06
28612SUPPL2007-07-27
16381SUPPL2007-07-27
51705SUPPL2007-04-23
16380SUPPL2007-03-31
6201SUPPL2007-03-31
6200SUPPL2007-03-06
37661SUPPL2007-02-26
51703SUPPL2006-11-28
21821ORIG2005-07-12
37660ORIG2005-03-31
6199ORIG2005-03-31
52476ORIG1900-01-01
52475ORIG1900-01-01
52474ORIG1900-01-01