FDA.reportPublic FDA data

Application 021798

Type
NDA
Sponsor
BRISTOL MYERS SQUIBB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BARACLUDEENTECAVIRSOLUTION;ORAL0.05MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0003-1614BARACLUDEentecavirE.R. Squibb & Sons, L.L.C.NDACurrent
0003-1614BARACLUDEentecavirE.R. Squibb & Sons, L.L.CNDACurrent
0003-1614BARACLUDEentecavirE.R. Squibb & Sons, L.L.C.NDACurrent
0003-1614BARACLUDEentecavirE.R. Squibb & Sons, L.L.C.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
60973SUPPL2019-11-19
60813SUPPL2019-11-12
56994SUPPL2018-12-21
56953SUPPL2018-12-21
54814SUPPL2018-07-06
54709SUPPL2018-06-27
16391SUPPL2014-03-25
28621SUPPL2014-03-21
16390SUPPL2013-12-23
28620SUPPL2013-12-20
51712SUPPL2013-05-31
37673SUPPL2012-10-15
28619SUPPL2012-10-15
16389SUPPL2012-10-15
6214SUPPL2012-10-15
28618SUPPL2011-01-04
37672SUPPL2010-12-28
16388SUPPL2010-10-29
51708SUPPL2010-06-28
16386SUPPL2009-07-24
6212SUPPL2009-07-22
16387SUPPL2009-03-17
6213SUPPL2009-02-27
37671SUPPL2008-08-13
6210SUPPL2008-07-31
6211SUPPL2008-06-06
37670SUPPL2007-07-27
6209SUPPL2007-07-27
51706SUPPL2007-04-23
16385SUPPL2007-03-31
6208SUPPL2007-03-31
6207SUPPL2007-03-06
37669SUPPL2007-02-26
51704SUPPL2006-11-28
42316ORIG2005-12-06
28617ORIG2005-03-31
16384ORIG2005-03-31
63909ORIG1900-01-01
63908ORIG1900-01-01
63907ORIG1900-01-01
63906ORIG1900-01-01