FDA.reportPublic FDA data

Application 020623

Type
NDA
Sponsor
US PHARM HOLDINGS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ANZEMETDOLASETRON MESYLATETABLET;ORAL50MGYesNo
002ANZEMETDOLASETRON MESYLATETABLET;ORAL100MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
30698-120ANZEMETdolasetron mesylateValidus Pharmaceuticals LLCNDACurrent
30698-121ANZEMETdolasetron mesylateValidus Pharmaceuticals LLCNDACurrent
30698-220ANZEMETdolasetron mesylateValidus Pharmaceuticals LLCNDACurrent
30698-220ANZEMETdolasetron mesylateValidus Pharmaceuticals LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
2895SUPPL2014-09-23
12859SUPPL2014-09-22
25334SUPPL2013-09-17
34969SUPPL2013-09-16
34968SUPPL2011-09-28
2894SUPPL2011-09-27
41486ORIG2010-03-03
25333SUPPL2009-11-10
12858SUPPL2009-10-14
25332SUPPL2007-09-26
12857SUPPL2007-06-04
2893SUPPL2007-06-04
34967SUPPL2005-06-07
2892SUPPL2005-06-07