Details for New Drug Application (NDA): 019711

NDA 019711 describes ISOLYTE S IN PLASTIC CONTAINER, which is a drug marketed by B Braun and is included in two NDAs. It is available from one supplier. Additional details are available on the ISOLYTE S IN PLASTIC CONTAINER profile page.

The generic ingredient in ISOLYTE S IN PLASTIC CONTAINER is magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconate. There are one hundred and forty-six drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconate profile page.

Summary for 019711

Tradename:	ISOLYTE S IN PLASTIC CONTAINER
Applicant:	B Braun
Ingredient:	magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconate
Patents:	0

Pharmacology for NDA: 019711

Mechanism of Action	Magnesium Ion Exchange Activity Osmotic Activity
Physiological Effect	Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption Inhibition Small Intestine Fluid/Electrolyte Absorption Stimulation Large Intestine Fluid/Electrolyte Secretion

Suppliers and Packaging for NDA: 019711

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ISOLYTE S IN PLASTIC CONTAINER	magnesium chloride; potassium chloride; sodium acetate; sodium chloride; sodium gluconate	INJECTABLE;INJECTION	019711	NDA	B. Braun Medical Inc.	0264-7703	0264-7703-00	12 CONTAINER in 1 CASE (0264-7703-00) / 1000 mL in 1 CONTAINER

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML
Approval Date:	Sep 29, 1989	TE:		RLD:	No

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