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Last Updated: March 19, 2024

Details for New Drug Application (NDA): 019685


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NDA 019685 describes POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S 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 LACTATED RINGER'S IN PLASTIC CONTAINER profile page.

The generic ingredient in POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER is calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate. There are two hundred and eighty-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate profile page.
Suppliers and Packaging for NDA: 019685
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate INJECTABLE;INJECTION 019685 NDA ICU Medical Inc. 0990-7111 0990-7111-09 12 POUCH in 1 CASE (0990-7111-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate INJECTABLE;INJECTION 019685 NDA ICU Medical Inc. 0990-7111 0990-7111-09 12 POUCH in 1 CASE (0990-7111-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength20MG/100ML;5GM/100ML;104MG/100ML;600MG/100ML;310MG/100ML
Approval Date:Oct 17, 1988TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML
Approval Date:Oct 17, 1988TE:APRLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength20MG/100ML;5GM/100ML;254MG/100ML;600MG/100ML;310MG/100ML
Approval Date:Oct 17, 1988TE:RLD:Yes

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