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Generated: October 22, 2018

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Details for New Drug Application (NDA): 018362

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NDA 018362 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 eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the dextrose; potassium chloride; sodium chloride profile page.
Suppliers and Packaging for NDA: 018362
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018362 NDA Hospira, Inc. 0409-7902 0409-7902-03 24 POUCH in 1 CASE (0409-7902-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018362 NDA Hospira, Inc. 0409-7902 0409-7902-03 24 POUCH in 1 CASE (0409-7902-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5GM/100ML;224MG/100ML;450MG/100ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5GM/100ML;298MG/100ML;450MG/100ML
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

Profile for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength5GM/100ML;149MG/100ML;450MG/100ML
Approval Date:Mar 28, 1988TE:RLD:Yes

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