Details for New Drug Application (NDA): 018090

NDA 018090 describes SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, which is a drug marketed by B Braun, Baxter Hlthcare, Fresenius Kabi Usa, Hospira, Icu Medical Inc, and Miles, and is included in eleven NDAs. It is available from five suppliers. Additional details are available on the SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER profile page.

The generic ingredient in SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER is sodium chloride. There are one thousand four hundred and seventy-two drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the sodium chloride profile page.

Summary for 018090

Tradename:	SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
Applicant:	Icu Medical Inc
Ingredient:	sodium chloride
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 018090

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

Suppliers and Packaging for NDA: 018090

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	sodium chloride	INJECTABLE;INJECTION	018090	NDA	ICU Medical Inc.	0990-7730	0990-7730-36	20 POUCH in 1 CASE (0990-7730-36) / 4 BAG in 1 POUCH / 50 mL in 1 BAG
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	sodium chloride	INJECTABLE;INJECTION	018090	NDA	ICU Medical Inc.	0990-7730	0990-7730-37	20 POUCH in 1 CASE (0990-7730-37) / 4 BAG in 1 POUCH / 100 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	450MG/100ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AP	RLD:	Yes

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