Details for New Drug Application (NDA): 078446

NDA 078446 describes POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, which is a drug marketed by Otsuka Icu Medcl and is included in one NDA. It is available from one supplier. Additional details are available on the POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER profile page.

The generic ingredient in POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER is potassium chloride; sodium chloride. There are two hundred and forty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the potassium chloride; sodium chloride profile page.

Summary for 078446

Tradename:	POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
Applicant:	Otsuka Icu Medcl
Ingredient:	potassium chloride; sodium chloride
Patents:	0

Pharmacology for NDA: 078446

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

Suppliers and Packaging for NDA: 078446

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	potassium chloride; sodium chloride	INJECTABLE;INJECTION	078446	ANDA	ICU Medical Inc.	0990-9257	0990-9257-39	12 POUCH in 1 CASE (0990-9257-39) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	149MG/100ML;450MG/100ML
Approval Date:	Sep 10, 2008	TE:	AP	RLD:	No

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