Details for New Drug Application (NDA): 017514

NDA 017514 describes SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, which is a drug marketed by B Braun, Fresenius Kabi Usa, Fresenius Medcl, Gvs Tm, Hospira, Laboratorios Grifols, Liebel-flarsheim, Otsuka Icu Medcl, Abbott, Baxter Hlthcare, Icu Medical Inc, Jubilant Cadista, Miles, Nephron, and Taro, and is included in twenty-seven NDAs. It is available from twenty-two suppliers. Additional details are available on the SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER profile page.

The generic ingredient in SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER is sodium chloride. There are one thousand four hundred and seventy-two drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the sodium chloride profile page.

Summary for 017514

Tradename:	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Applicant:	Otsuka Icu Medcl
Ingredient:	sodium chloride
Patents:	0

Pharmacology for NDA: 017514

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

Suppliers and Packaging for NDA: 017514

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	sodium chloride	SOLUTION;IRRIGATION	017514	NDA	ICU Medical Inc.	0990-6138	0990-6138-03	24 BOTTLE, PLASTIC in 1 CASE (0990-6138-03) / 500 mL in 1 BOTTLE, PLASTIC
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	sodium chloride	SOLUTION;IRRIGATION	017514	NDA	ICU Medical Inc.	0990-7138	0990-7138-09	12 BOTTLE, PLASTIC in 1 CASE (0990-7138-09) / 1000 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;IRRIGATION			Strength	900MG/100ML
Approval Date:	Approved Prior to Jan 1, 1982	TE:	AT	RLD:	Yes

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