Details for New Drug Application (NDA): 206486

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NDA 206486 describes MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER, which is a drug marketed by B Braun Medical, Baxter Hlthcare Corp, Fresenius Kabi Usa, Hospira, Hq Spclt Pharma, and Pharmobedient, and is included in six NDAs. It is available from five suppliers. Additional details are available on the MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER profile page.

The generic ingredient in MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER is magnesium sulfate. There is one drug master file entry for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the magnesium sulfate profile page.

Tradename:	MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER
Applicant:	Fresenius Kabi Usa
Ingredient:	magnesium sulfate
Patents:	0

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

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	magnesium sulfate	INJECTABLE;INJECTION	206486	ANDA	Fresenius Kabi USA, LLC	63323-108	63323-108-01	24 BAG in 1 CASE (63323-108-01) / 100 mL in 1 BAG (63323-108-00)
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER	magnesium sulfate	INJECTABLE;INJECTION	206486	ANDA	Fresenius Kabi USA, LLC	63323-108	63323-108-26	24 BAG in 1 CASE (63323-108-26) / 100 mL in 1 BAG (63323-108-02)

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	1GM/100ML
Approval Date:	Mar 7, 2016	TE:	AP	RLD:	No

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