FDA.reportPublic FDA data

Application 019904

Type
NDA
Sponsor
BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINERPOTASSIUM CHLORIDEINJECTABLE;INJECTION14.9MG/MLYesYes
002POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINERPOTASSIUM CHLORIDEINJECTABLE;INJECTION29.8MG/MLYesYes
003POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINERPOTASSIUM CHLORIDEINJECTABLE;INJECTION2.24GM/100MLYesYes
004POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINERPOTASSIUM CHLORIDEINJECTABLE;INJECTION2.98GM/100MLYesYes
005POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINERPOTASSIUM CHLORIDEINJECTABLE;INJECTION746MG/100MLYesYes
006POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINERPOTASSIUM CHLORIDEINJECTABLE;INJECTION1.49GM/100MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0338-0703Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare CorporationNDACurrent
0338-0703Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare CorporationNDACurrent
0338-0703Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare CorporationNDACurrent
0338-0703Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare CorporationNDACurrent
0338-0703Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare CorporationNDACurrent
0338-0703Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare CorporaNDACurrent
0338-0703Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare CorporationNDACurrent
0338-0705Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare CorporationNDACurrent
0338-0705Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare CorporaNDACurrent
0338-0705Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare CorporationNDACurrent
0338-0705Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare CorporationNDACurrent
0338-0705Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare CorporationNDACurrent
0338-0705Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare CorporationNDACurrent
0338-0705Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare CorporationNDACurrent
0338-0707Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare CorporaNDACurrent
0338-0709Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare CorporationNDACurrent
0338-0709Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare CorporationNDACurrent
0338-0709Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare CorporationNDACurrent
0338-0709Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare CorporationNDACurrent
0338-0709Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare CorporationNDACurrent
0338-0709Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare CorporationNDACurrent
0338-0709Potassium ChloridePOTASSIUM CHLORIDEBaxter Healthcare CorporaNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78800SUPPL 2024-06-14
78798SUPPL 2024-06-14
71333SUPPL2022-06-15
71298SUPPL2022-06-14
59153SUPPL2019-06-21
59145SUPPL2019-06-21
46840SUPPL2017-01-13
46762SUPPL2017-01-06
1797SUPPL2012-03-16