FDA.reportPublic FDA data

Application 019631

Type
NDA
Sponsor
B BRAUN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINERDEXTROSE; SODIUM CHLORIDEINJECTABLE;INJECTION2.5GM/100ML;110MG/100MLNoNo
002DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINERDEXTROSE; SODIUM CHLORIDEINJECTABLE;INJECTION2.5GM/100ML;200MG/100MLNoNo
003DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINERDEXTROSE; SODIUM CHLORIDEINJECTABLE;INJECTION2.5GM/100ML;330MG/100MLNoNo
004DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERDEXTROSE; SODIUM CHLORIDEINJECTABLE;INJECTION2.5GM/100ML;450MG/100MLNoNo
005DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDEXTROSE; SODIUM CHLORIDEINJECTABLE;INJECTION2.5GM/100ML;900MG/100MLNoNo
006DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINERDEXTROSE; SODIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;110MG/100MLNoNo
007DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINERDEXTROSE; SODIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;200MG/100MLNoNo
008DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINERDEXTROSE; SODIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;330MG/100MLNoNo
009DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERDEXTROSE; SODIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;450MG/100MLNoNo
010DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDEXTROSE; SODIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;900MG/100MLNoNo
011DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINERDEXTROSE; SODIUM CHLORIDEINJECTABLE;INJECTION10GM/100ML;110MG/100MLNoNo
012DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINERDEXTROSE; SODIUM CHLORIDEINJECTABLE;INJECTION10GM/100ML;200MG/100MLNoNo
013DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINERDEXTROSE; SODIUM CHLORIDEINJECTABLE;INJECTION10GM/100ML;330MG/100MLNoNo
014DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERDEXTROSE; SODIUM CHLORIDEINJECTABLE;INJECTION10GM/100ML;450MG/100MLNoNo
015DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERDEXTROSE; SODIUM CHLORIDEINJECTABLE;INJECTION10GM/100ML;900MG/100MLNoNo
016DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINERDEXTROSE; SODIUM CHLORIDEINJECTABLE;INJECTION3.3GM/100ML;300MG/100MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0264-7605Dextrose And Sodium ChlorideDEXTROSE and SODIUM CHLORIDEB. Braun Medical Inc.NDACurrent
0264-7608Dextrose And Sodium ChlorideDEXTROSE and SODIUM CHLORIDEB. Braun Medical Inc.NDACurrent
0264-7608Dextrose And Sodium ChlorideDEXTROSE and SODIUM CHLORIDEB. Braun Medical Inc.NDACurrent
0264-7610Dextrose And Sodium ChlorideDEXTROSE and SODIUM CHLORIDEB. Braun Medical Inc.NDACurrent
0264-7610Dextrose And Sodium ChlorideDEXTROSE and SODIUM CHLORIDEB. Braun Medical Inc.NDACurrent
0264-7612Dextrose And Sodium ChlorideDEXTROSE and SODIUM CHLORIDEB. Braun Medical Inc.NDACurrent
0264-7612Dextrose And Sodium ChlorideDEXTROSE and SODIUM CHLORIDEB. Braun Medical Inc.NDACurrent
0264-7614Dextrose And Sodium ChlorideDEXTROSE and SODIUM CHLORIDEB. Braun Medical Inc.NDACurrent
0264-7614Dextrose And Sodium ChlorideDEXTROSE and SODIUM CHLORIDEB. Braun Medical Inc.NDACurrent
0264-7616Dextrose And Sodium ChlorideDEXTROSE and SODIUM CHLORIDEB. Braun Medical Inc.NDACurrent
0264-7616Dextrose And Sodium ChlorideDEXTROSE and SODIUM CHLORIDEB. Braun Medical Inc.NDACurrent
0264-7622Dextrose And Sodium ChlorideDEXTROSE and SODIUM CHLORIDEB. Braun Medical Inc.NDACurrent
0264-7622Dextrose And Sodium ChlorideDEXTROSE and SODIUM CHLORIDEB. Braun Medical Inc.NDACurrent
0264-7623Dextrose And Sodium ChlorideDEXTROSE and SODIUM CHLORIDEB. Braun Medical Inc.NDACurrent
0264-7623Dextrose And Sodium ChlorideDEXTROSE and SODIUM CHLORIDEB. Braun Medical Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
33817SUPPL2004-09-29
17494SUPPL2004-09-29