FDA.reportPublic FDA data

Application 019884

Type
NDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MESNEXMESNAINJECTABLE;INTRAVENOUS100MG/MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0338-1305MESNEXmesnaBaxter Healthcare CorporationNDACurrent
0338-1305MESNEXmesnaBaxter Healthcare CorporationNDACurrent
0338-1305MESNEXmesnaBaxter Healthcare CorporationNDACurrent
0338-1305MESNEXmesnaBaxter Healthcare CorporationNDACurrent
0338-1307MESNEXMESNABaxter Healthcare CorporationNDACurrent
0338-1307MESNEXMESNABaxter Healthcare CorporationNDACurrent
10019-951MESNAMESNABaxter Healthcare CorporationNDACurrent
10019-951MESNAMESNABaxter Healthcare CorporationNDACurrent
10019-951MESNAMESNABaxter Healthcare CorporationNDACurrent
10019-951MESNAMESNABaxter Healthcare CorporationNDACurrent
10019-953MESNAMESNABaxter Healthcare CorporationNDACurrent
10019-953MESNAMESNABaxter Healthcare CorporationNDACurrent
10019-953MESNAMESNABaxter Healthcare CorporationNDACurrent
10019-953MESNAMESNABaxter Healthcare CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56920SUPPL2018-12-21
56760SUPPL2018-12-18
11806SUPPL2014-03-19
1751SUPPL2014-03-19
19789SUPPL2003-01-30
1750SUPPL2003-01-30