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Generated: October 23, 2018

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Details for New Drug Application (NDA): 018365

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NDA 018365 describes POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, which is a drug marketed by Icu Medical Inc and is included in one NDA. It is available from one supplier. Additional details are available on the POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER profile page.

The generic ingredient in POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% 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: 018365
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018365 NDA Hospira, Inc. 0409-7901 0409-7901-03 24 POUCH in 1 CASE (0409-7901-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018365 NDA Hospira, Inc. 0409-7901 0409-7901-03 24 POUCH in 1 CASE (0409-7901-03) > 1 BAG in 1 POUCH > 500 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5GM/100ML;149MG/100ML;225MG/100ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5GM/100ML;74.5MG/100ML;225MG/100ML
Approval Date:Jul 5, 1983TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5GM/100ML;224MG/100ML;225MG/100ML
Approval Date:Jul 5, 1983TE:RLD:No

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Covington
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