Details for New Drug Application (NDA): 019416

NDA 019416 describes LACTATED RINGER'S IN PLASTIC CONTAINER, which is a drug marketed by Abbott, B Braun, Baxter Hlthcare, Fresenius Kabi Usa, Icu Medical Inc, and Miles, and is included in twelve NDAs. It is available from seven suppliers. Additional details are available on the LACTATED RINGER'S IN PLASTIC CONTAINER profile page.

The generic ingredient in LACTATED RINGER'S IN PLASTIC CONTAINER is calcium chloride; potassium chloride; sodium chloride; sodium lactate. There are two hundred and eighty-two drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the calcium chloride; potassium chloride; sodium chloride; sodium lactate profile page.

Summary for 019416

Tradename:	LACTATED RINGER'S IN PLASTIC CONTAINER
Applicant:	Icu Medical Inc
Ingredient:	calcium chloride; potassium chloride; sodium chloride; sodium lactate
Patents:	0

Pharmacology for NDA: 019416

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

Suppliers and Packaging for NDA: 019416

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LACTATED RINGER'S IN PLASTIC CONTAINER	calcium chloride; potassium chloride; sodium chloride; sodium lactate	SOLUTION;IRRIGATION	019416	NDA	ICU Medical Inc.	0990-7828	0990-7828-08	4 POUCH in 1 CASE (0990-7828-08) / 1 BAG in 1 POUCH / 3000 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;IRRIGATION			Strength	20MG/100ML;30MG/100ML;600MG/100ML;310MG/100ML
Approval Date:	Jan 17, 1986	TE:	AT	RLD:	Yes

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