Application 018037

Type
NDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K)DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;300MG/100ML;200MG/100MLNoNo
002DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQDEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;75MG/100ML;200MG/100MLNoNo
003DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K)DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;150MG/100ML;200MG/100MLNoNo
004DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K)DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;224MG/100ML;200MG/100MLNoNo
005DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 30MEQDEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;224MG/100ML;200MG/100MLNoNo
006DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQDEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;75MG/100ML;200MG/100MLNoNo
007DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQDEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;150MG/100ML;200MG/100MLNoNo
008DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQDEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;150MG/100ML;200MG/100MLNoNo
009DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQDEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;300MG/100ML;200MG/100MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0338-0663Potassium Chloride in Dextrose and Sodium ChloridePotassium Chloride, Dextrose Monohydrate and Sodium ChlorideBaxter Healthcare CorporationNDACurrent
0338-0663Potassium Chloride in Dextrose and Sodium ChloridePotassium Chloride, Dextrose Monohydrate and Sodium ChlorideBaxter Healthcare CorporationNDACurrent
0338-0663Potassium Chloride in Dextrose and Sodium ChloridePotassium Chloride, Dextrose Monohydrate and Sodium ChlorideBaxter Healthcare CorporationNDACurrent
0338-0663Potassium Chloride in Dextrose and Sodium ChloridePotassium Chloride, Dextrose Monohydrate and Sodium ChlorideBaxter Healthcare CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
58035SUPPL2019-03-19
57757SUPPL2019-02-22
808SUPPL2013-09-12
11131SUPPL2013-09-11
13995SUPPL2007-05-01
11130SUPPL2007-04-25
33405SUPPL2005-08-31
807SUPPL2005-08-31
13994SUPPL2004-06-07
806SUPPL2003-05-29