Application 019708

Type
NDA
Sponsor
B BRAUN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPOTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION37MG/100ML;900MG/100MLNoNo
002POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPOTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION75MG/100ML;900MG/100MLNoNo
003POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPOTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION110MG/100ML;900MG/100MLNoNo
004POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPOTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION150MG/100ML;900MG/100MLNoNo
005POTASSIUM CHLORIDE 0.22% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPOTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION220MG/100ML;900MG/100MLNoNo
006POTASSIUM CHLORIDE 0.3% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPOTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION300MG/100ML;900MG/100MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0264-7865POTASSIUM CHLORIDE IN SODIUM CHLORIDESODIUM CHLORIDE and POTASSIUM CHLORIDEB. Braun Medical Inc.NDACurrent
0264-7865POTASSIUM CHLORIDE IN SODIUM CHLORIDESODIUM CHLORIDE and POTASSIUM CHLORIDEB. Braun Medical Inc.NDACurrent
0264-7865POTASSIUM CHLORIDE IN SODIUM CHLORIDESODIUM CHLORIDE and POTASSIUM CHLORIDEB. Braun Medical Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84824SUPPL 2026-01-22
84823SUPPL 2026-01-22
19110SUPPL2005-09-08
19109SUPPL2004-09-29
11642SUPPL2004-09-29