FDA.reportPublic FDA data

Application 016683

Type
NDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERDEXTROSE; SODIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;450MG/100MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0338-0085Dextrose and Sodium ChlorideDextrose and Sodium ChlorideBaxter Healthcare CorporationNDACurrent
0338-0085Dextrose and Sodium ChlorideDextrose and Sodium ChlorideBaxter Healthcare CorporationNDACurrent
0338-0085Dextrose and Sodium ChlorideDextrose and Sodium ChlorideBaxter Healthcare CorporationNDACurrent
0338-0085Dextrose and Sodium ChlorideDextrose and Sodium ChlorideBaxter Healthcare CorporationNDACurrent
0338-0085Dextrose and Sodium ChlorideDextrose and Sodium ChlorideBaxter Healthcare CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59906SUPPL2019-09-04
59832SUPPL2019-08-23
480SUPPL2013-09-12
33191SUPPL2013-09-11