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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 018008


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NDA 018008 describes POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare and Icu Medical Inc and is included in two NDAs. It is available from two suppliers. Additional details are available on the POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER profile page.

The generic ingredient in POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER is dextrose; potassium chloride; sodium chloride. There are nine drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dextrose; potassium chloride; sodium chloride profile page.
Pharmacology for NDA: 018008
Suppliers and Packaging for NDA: 018008
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018008 NDA Baxter Healthcare Corporation 0338-0669 0338-0669-04 1000 mL in 1 BAG (0338-0669-04)
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018008 NDA Baxter Healthcare Corporation 0338-0669 0338-0669-04 1000 mL in 1 BAG (0338-0669-04)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength5GM/100ML;300MG/100ML;450MG/100ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength5GM/100ML;75MG/100ML;450MG/100ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength5GM/100ML;224MG/100ML;450MG/100ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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