FDA.reportPublic FDA data

Application 021858

Type
NDA
Sponsor
ROCHE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BONIVAIBANDRONATE SODIUMINJECTABLE;INTRAVENOUSEQ 3MG BASE/3MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0004-0191Bonivaibandronate sodiumGenentech, Inc.NDACurrent
0004-0191Bonivaibandronate sodiumGenentech, Inc.NDACurrent
0004-0191Bonivaibandronate sodiumGenentech, Inc.NDACurrent
0004-0191Bonivaibandronate sodiumGenentech, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
69846SUPPL2022-01-12
69845SUPPL2022-01-12
46648SUPPL2017-01-03
46141SUPPL2016-12-13
46105SUPPL2016-12-09
6316SUPPL2015-04-13
37769SUPPL2015-04-10
37768SUPPL2015-03-19
6315SUPPL2015-03-19
28721SUPPL2013-04-24
28717SUPPL2013-04-24
6314SUPPL2013-04-24
37767SUPPL2013-04-23
37766SUPPL2013-04-23
16465SUPPL2013-04-23
28719SUPPL2011-08-12
28720SUPPL2011-07-07
28718SUPPL2011-01-27
16464SUPPL2011-01-26
44156ORIG2008-01-07
21844ORIG2007-05-09
6313SUPPL2007-02-23
16463SUPPL2006-08-09
6312SUPPL2006-08-09
16462ORIG2006-01-10
6311ORIG2006-01-10