Details for New Drug Application (NDA): 018508

NDA 018508 describes TIS-U-SOL, which is a drug marketed by Baxter Hlthcare and is included in two NDAs. It is available from one supplier. Additional details are available on the TIS-U-SOL profile page.

The generic ingredient in TIS-U-SOL is magnesium sulfate; potassium chloride; potassium phosphate, monobasic; sodium chloride; sodium phosphate. There are one hundred and forty-six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the magnesium sulfate; potassium chloride; potassium phosphate, monobasic; sodium chloride; sodium phosphate profile page.

Summary for 018508

Tradename:	TIS-U-SOL
Applicant:	Baxter Hlthcare
Ingredient:	magnesium sulfate; potassium chloride; potassium phosphate, monobasic; sodium chloride; sodium phosphate
Patents:	0

Pharmacology for NDA: 018508

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: 018508

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TIS-U-SOL	magnesium sulfate; potassium chloride; potassium phosphate, monobasic; sodium chloride; sodium phosphate	SOLUTION;IRRIGATION	018508	NDA	Baxter Healthcare Corporation	0338-0190	0338-0190-04	12 BOTTLE, PLASTIC in 1 CARTON (0338-0190-04) / 1000 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;IRRIGATION			Strength	20MG/100ML;40MG/100ML;6.25MG/100ML;800MG/100ML;8.75MG/100ML
Approval Date:	Feb 19, 1982	TE:	AT	RLD:	No

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