FDA.reportPublic FDA data

Application 017648

Type
NDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPOTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION150MG/100ML;900MG/100MLYesNo
002POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERPOTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION300MG/100ML;900MG/100MLYesNo
003POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9%POTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION224MG/100ML;900MG/100MLYesNo
004SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINERPOTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION75MG/100ML;900MG/100MLNoNo
005POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINERPOTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION150MG/100ML;450MG/100MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0338-0691Potassium Chloride in Sodium ChloridePotassium Chloride and Sodium ChlorideBaxter Healthcare CorporationNDACurrent
0338-0691Potassium Chloride in Sodium ChloridePotassium Chloride and Sodium ChlorideBaxter Healthcare CorporationNDACurrent
0338-0691Potassium Chloride in Sodium ChloridePotassium Chloride and Sodium ChlorideBaxter Healthcare CorporationNDACurrent
0338-0691Potassium Chloride in Sodium ChloridePotassium Chloride and Sodium ChlorideBaxter Healthcare CorporationNDACurrent
0338-0695Potassium Chloride in Sodium ChloridePotassium Chloride and Sodium ChlorideBaxter Healthcare CorporationNDACurrent
0338-0695Potassium Chloride in Sodium ChloridePotassium Chloride and Sodium ChlorideBaxter Healthcare CorporationNDACurrent
0338-0695Potassium Chloride in Sodium ChloridePotassium Chloride and Sodium ChlorideBaxter Healthcare CorporationNDACurrent
0338-0695Potassium Chloride in Sodium ChloridePotassium Chloride and Sodium ChlorideBaxter Healthcare CorporationNDACurrent
0338-0704Potassium Chloride in Sodium ChloridePotassium Chloride and Sodium ChlorideBaxter Healthcare CorporationNDACurrent
0338-0704Potassium Chloride in Sodium ChloridePotassium Chloride and Sodium ChlorideBaxter Healthcare CorporationNDACurrent
0338-0704Potassium Chloride in Sodium ChloridePotassium Chloride and Sodium ChlorideBaxter Healthcare CorporationNDACurrent
0338-0704Potassium Chloride in Sodium ChloridePotassium Chloride and Sodium ChlorideBaxter Healthcare CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57352SUPPL2019-01-28
57256SUPPL2019-01-18
33326SUPPL2005-08-31
673SUPPL2005-08-31
33325SUPPL2005-05-25
672SUPPL2005-05-25
13876SUPPL2003-01-10
13875ORIG2002-11-26