FDA.reportPublic FDA data

Application 016689

Type
NDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXTROSE 5% IN SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINERDEXTROSE; SODIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;200MG/100MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0338-0077Dextrose and Sodium ChlorideDextrose and Sodium ChlorideBaxter Healthcare CorporationNDACurrent
0338-0077Dextrose and Sodium ChlorideDextrose and Sodium ChlorideBaxter Healthcare CorporationNDACurrent
0338-0077Dextrose and Sodium ChlorideDextrose and Sodium ChlorideBaxter Healthcare CorporationNDACurrent
0338-0077Dextrose and Sodium ChlorideDextrose and Sodium ChlorideBaxter Healthcare CorporationNDACurrent
0338-0077Dextrose and Sodium ChlorideDextrose and Sodium ChlorideBaxter Healthcare CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59908SUPPL2019-09-04
59835SUPPL2019-08-23
483SUPPL2013-09-12
10913SUPPL2013-09-11