Details for New Drug Application (NDA): 211966

NDA 211966 describes MAGNESIUM SULFATE IN PLASTIC CONTAINER, which is a drug marketed by Amneal, Baxter Hlthcare Corp, Fresenius Kabi Usa, Gland, Hospira, Hq Spclt Pharma, Milla Pharms, and Pharmobedient, and is included in eight NDAs. It is available from twelve suppliers. Additional details are available on the MAGNESIUM SULFATE IN PLASTIC CONTAINER profile page.

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

Tradename:	MAGNESIUM SULFATE IN PLASTIC CONTAINER
Applicant:	Baxter Hlthcare Corp
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	magnesium sulfate	INJECTABLE;INJECTION	211966	ANDA	Baxter Healthcare Corporation	0338-1708	0338-1708-40	40 BAG in 1 CARTON (0338-1708-40) / 50 mL in 1 BAG
MAGNESIUM SULFATE	magnesium sulfate	INJECTABLE;INJECTION	211966	ANDA	Baxter Healthcare Corporation	0338-1715	0338-1715-40	40 BAG in 1 CARTON (0338-1715-40) / 100 mL in 1 BAG

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	2GM/50ML (40MG/ML)
Approval Date:	Jun 1, 2020	TE:	AP	RLD:	No

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	4GM/50ML (80MG/ML)
Approval Date:	Jun 1, 2020	TE:	AP	RLD:	No

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	4GM/100ML (40MG/ML)
Approval Date:	Jun 1, 2020	TE:	AP	RLD:	No

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