FDA.reportPublic FDA data

Application 021223

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZOMETAZOLEDRONIC ACIDINJECTABLE;INTRAVENOUSEQ 4MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002ZOMETAZOLEDRONIC ACIDINJECTABLE;INTRAVENOUSEQ 4MG BASE/5MLYesYes
003ZOMETAZOLEDRONIC ACIDINJECTABLE;INTRAVENOUSEQ 4MG BASE/100MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0078-0387Zometazoledronic acidNovartis Pharmaceuticals CorporationNDACurrent
0078-0387Zometazoledronic acidNovartis Pharmaceuticals CorporationNDACurrent
0078-0387Zometazoledronic acidNovartis Pharmaceuticals CorporationNDACurrent
0078-0387Zometazoledronic acidNovartis Pharmaceuticals CorporationNDACurrent
0078-0590Zometazoledronic acidNovartis Pharmaceuticals CorporationNDACurrent
0078-0590Zometazoledronic acidNovartis Pharmaceuticals CorporationNDACurrent
0078-0590Zometazoledronic acidNovartis Pharmaceuticals CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57147SUPPL2019-01-09
56912SUPPL2018-12-21
46596SUPPL2016-12-30
46586SUPPL2016-12-29
27108SUPPL2016-04-04
36382SUPPL2016-03-31
36381SUPPL2015-06-11
4666SUPPL2015-06-10
14661SUPPL2015-01-08
27107SUPPL2015-01-07
27106SUPPL2014-04-08
14660SUPPL2014-04-08
36380SUPPL2013-10-01
27105SUPPL2013-10-01
36379SUPPL2012-11-15
4665SUPPL2012-11-14
36378SUPPL2012-03-16
27104SUPPL2012-03-16
27103SUPPL2010-01-25
14659SUPPL2009-11-17
42035SUPPL2008-08-01
14658SUPPL2008-03-24
27102SUPPL2008-03-21
27101SUPPL2007-11-08
27100SUPPL2007-11-08
14657SUPPL2007-11-07
36377SUPPL2006-05-26
4664SUPPL2006-05-26
27099SUPPL2005-10-14
14656SUPPL2005-10-14
36376SUPPL2005-02-03
27098SUPPL2005-02-03
27097SUPPL2005-02-03
14655SUPPL2005-02-03
14654SUPPL2004-04-05
27096SUPPL2004-03-28
36375SUPPL2004-03-25
4663SUPPL2004-03-02
23634ORIG2003-12-12
14653SUPPL2003-03-26
4662SUPPL2003-03-26
42034SUPPL2002-02-22
14652SUPPL2002-02-22
4661SUPPL2002-02-22
36374ORIG2001-08-20
27095ORIG2001-08-20
21517ORIG2001-08-20
53444ORIG1900-01-01
53443ORIG1900-01-01
53442ORIG1900-01-01
52394ORIG1900-01-01