FDA.reportPublic FDA data

Application 016679

Type
NDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINERCALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATEINJECTABLE;INJECTION20MG/100ML;5GM/100ML;30MG/100ML;600MG/100ML;310MG/100MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0338-0125Lactated Ringers and DextroseSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE and DEXTROSE MONOHYDRATEBaxter Healthcare CorporationNDACurrent
0338-0125Lactated Ringers and DextroseSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE and DEXTROSE MONOHYDRATEBaxter Healthcare CorporationNDACurrent
0338-0125Lactated Ringers and DextroseSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE and DEXTROSE MONOHYDRATEBaxter Healthcare CorporationNDACurrent
0338-0125Lactated Ringers and DextroseSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE and DEXTROSE MONOHYDRATEBaxter Healthcare CorporationNDACurrent
0338-0125Lactated Ringers and DextroseSODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE and DEXTROSE MONOHYDRATEBaxter Healthcare CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84115SUPPL 2025-11-06
60528SUPPL2020-01-23
60516SUPPL2019-10-10
50639SUPPL2017-12-07
50636SUPPL2017-12-07
10911SUPPL2011-11-04
478SUPPL2011-10-24
13016SUPPL2004-05-27