Application 017634

Type
NDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;150MG/100MLYesNo
002DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;300MG/100MLYesNo
003DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;224MG/100MLYesNo
004DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINERDEXTROSE; POTASSIUM CHLORIDEINJECTABLE;INJECTION5GM/100ML;75MG/100MLYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0338-0683Potassium Chloride in DextrosePotassium Chloride and Dextrose MonohydrateBaxter Healthcare CorporationNDACurrent
0338-0683Potassium Chloride in DextrosePotassium Chloride and Dextrose MonohydrateBaxter Healthcare CorporationNDACurrent
0338-0683Potassium Chloride in DextrosePotassium Chloride and Dextrose MonohydrateBaxter Healthcare CorporationNDACurrent
0338-0683Potassium Chloride in DextrosePotassium Chloride and Dextrose MonohydrateBaxter Healthcare CorporationNDACurrent
0338-0683Potassium Chloride in DextrosePotassium Chloride and Dextrose MonohydrateBaxter Healthcare CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59349SUPPL2019-07-16
59339SUPPL2019-07-16
48608SUPPL2017-05-31
48607SUPPL2017-05-31
48595SUPPL2017-05-31
48594SUPPL2017-05-31
33323SUPPL2015-01-09
13873SUPPL2014-12-24
33322SUPPL2005-08-31
669SUPPL2005-08-31
33321SUPPL2005-05-25
668SUPPL2005-05-25
13872SUPPL2004-06-02