Details for New Drug Application (NDA): 020577

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NDA 020577 describes ELLIOTTS B SOLUTION, which is a drug marketed by Lukare Medical Llc and is included in one NDA. It is available from one supplier. Additional details are available on the ELLIOTTS B SOLUTION profile page.

The generic ingredient in ELLIOTTS B SOLUTION is calcium chloride; dextrose; magnesium sulfate; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate, dibasic, heptahydrate. There are two hundred and eighty-two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the calcium chloride; dextrose; magnesium sulfate; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate, dibasic, heptahydrate profile page.

Tradename:	ELLIOTTS B SOLUTION
Applicant:	Lukare Medical Llc
Ingredient:	calcium chloride; dextrose; magnesium sulfate; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate, dibasic, heptahydrate
Patents:	0

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

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ELLIOTTS B SOLUTION	calcium chloride; dextrose; magnesium sulfate; potassium chloride; sodium bicarbonate; sodium chloride; sodium phosphate, dibasic, heptahydrate	INJECTABLE;INTRATHECAL	020577	NDA	Lukare Medical, LLC	55792-007	55792-007-10	10 AMPULE in 1 BOX (55792-007-10) / 10 mL in 1 AMPULE (55792-007-01)

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRATHECAL			Strength	0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML
Approval Date:	Sep 27, 1996	TE:		RLD:	Yes

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