Application 019699

Type
NDA
Sponsor
B BRAUN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;37MG/100MLNoNo
002POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;75MG/100MLNoNo
003POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;110MG/100MLNoNo
004POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;150MG/100MLNoNo
005POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;220MG/100MLNoNo
006POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;300MG/100MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0264-7625POTASSIUM CHLORIDE IN DEXTROSEDEXTROSE and POTASSIUM CHLORIDEB. Braun Medical Inc.NDACurrent
0264-7625POTASSIUM CHLORIDE IN DEXTROSEDEXTROSE and POTASSIUM CHLORIDEB. Braun Medical Inc.NDACurrent
0264-7628POTASSIUM CHLORIDE IN DEXTROSEDEXTROSE and POTASSIUM CHLORIDEB. Braun Medical Inc.NDACurrent
0264-7628POTASSIUM CHLORIDE IN DEXTROSEDEXTROSE and POTASSIUM CHLORIDEB. Braun Medical Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
63889SUPPL2020-07-14
63854SUPPL2020-07-13
33875SUPPL2004-09-29
19106SUPPL2004-09-29