FDA.reportPublic FDA data

Application 016694

Type
NDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXTROSE 10% IN PLASTIC CONTAINERDEXTROSEINJECTABLE;INJECTION10GM/100MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0338-0023DEXTROSEDEXTROSE MONOHYDRATEBaxter Healthcare CorporationNDACurrent
0338-0023DEXTROSEDEXTROSE MONOHYDRATEBaxter Healthcare CorporationNDACurrent
0338-0023DEXTROSEDEXTROSE MONOHYDRATEBaxter Healthcare CorporationNDACurrent
0338-0023DEXTROSEDEXTROSE MONOHYDRATEBaxter Healthcare CorporationNDACurrent
0338-0023DEXTROSEDEXTROSE MONOHYDRATEBaxter Healthcare CorporationNDACurrent
0338-0023DEXTROSEDEXTROSE MONOHYDRATEBaxter Healthcare CorporationNDACurrent
0338-0023DEXTROSEDEXTROSE MONOHYDRATEBaxter Healthcare CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67164SUPPL2021-04-23
59600SUPPL2019-08-06
59585SUPPL2019-08-06
33194SUPPL2015-01-09
13022SUPPL2014-12-24