FDA.reportPublic FDA data

Application 016697

Type
NDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERDEXTROSE; SODIUM CHLORIDEINJECTABLE;INJECTION2.5GM/100ML;450MG/100MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0338-0073Dextrose and Sodium ChlorideDextrose and Sodium ChlorideBaxter Healthcare CorporationNDACurrent
0338-0073Dextrose and Sodium ChlorideDextrose and Sodium ChlorideBaxter Healthcare CorporationNDACurrent
0338-0073Dextrose and Sodium ChlorideDextrose and Sodium ChlorideBaxter Healthcare CorporationNDACurrent
0338-0073Dextrose and Sodium ChlorideDextrose and Sodium ChlorideBaxter Healthcare CorporationNDACurrent
0338-0073Dextrose and Sodium ChlorideDextrose and Sodium ChlorideBaxter Healthcare CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59909SUPPL2019-09-04
59834SUPPL2019-08-23
13024SUPPL2013-09-12
10916SUPPL2013-09-11