Details for New Drug Application (NDA): 211428

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NDA 211428 describes POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, which is a drug marketed by Baxter Hlthcare, Fresenius Kabi Usa, and Icu Medical Inc, and is included in three NDAs. It is available from three suppliers. Additional details are available on the POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER profile page.

The generic ingredient in POTASSIUM CHLORIDE 20MEQ 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.

Tradename:	POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
Applicant:	Fresenius Kabi Usa
Ingredient:	calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate
Patents:	0

Mechanism of Action	Osmotic Activity Phosphate Chelating Activity
Physiological Effect	Increased Coagulation Factor Activity Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER	calcium chloride; dextrose; potassium chloride; sodium chloride; sodium lactate	INJECTABLE;INJECTION	211428	ANDA	Fresenius Kabi USA, LLC	65219-246	65219-246-10	10 BAG in 1 CASE (65219-246-10) / 1000 mL in 1 BAG (65219-246-00)

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	20MG/100ML;5GM/100ML;179MG/100ML;600MG/100ML;310MG/100ML
Approval Date:	Nov 9, 2021	TE:		RLD:	No

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