FDA.reportPublic FDA data

Application 016267

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DESFERALDEFEROXAMINE MESYLATEINJECTABLE;INJECTION500MG/VIALYesYes
002DESFERALDEFEROXAMINE MESYLATEINJECTABLE;INJECTION2GM/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0078-0467Desferaldeferoxamine mesylateNovartis Pharmaceuticals CorporationNDACurrent
0078-0467Desferaldeferoxamine mesylateNovartis Pharmaceuticals CorporationNDACurrent
0078-0467Desferaldeferoxamine mesylateNovartis Pharmaceuticals CorporationNDACurrent
0078-0467Desferaldeferoxamine mesylateNovartis Pharmaceuticals CorporationNDACurrent
0078-0467Desferaldeferoxamine mesylateNovartis Pharmaceuticals CorporationNDACurrent
0078-0467Desferaldeferoxamine mesylateNovartis Pharmaceuticals CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72068SUPPL2022-09-13
72066SUPPL2022-09-12
12980SUPPL2011-12-21
10876SUPPL2011-12-20
33150SUPPL2010-09-10
12979SUPPL2010-09-09
10875SUPPL2009-02-04
426SUPPL2009-01-30
425SUPPL2007-01-25
33149SUPPL2007-01-24
424SUPPL2002-02-14
423SUPPL2001-04-09