FDA.reportPublic FDA data

Application 020855

Type
NDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MESNEXMESNATABLET;ORAL400MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67108-3565MESNEXMESNABaxter Healthcare CorporationNDACurrent
67108-3565MESNEXMESNABaxter Healthcare CorporationNDACurrent
67108-3565MESNEXMESNABaxter Healthcare CorporationNDACurrent
67108-3565MESNEXMESNABaxter Healthcare CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56921SUPPL2018-12-21
56764SUPPL2018-12-18
13620SUPPL2014-03-19
3579SUPPL2014-03-19
26061SUPPL2013-01-10
13619ORIG2004-06-09
26060ORIG2003-05-08
21021ORIG2003-05-08