Details for New Drug Application (NDA): 019316

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NDA 019316 describes MAGNESIUM SULFATE, which is a drug marketed by B Braun Medical, Baxter Hlthcare Corp, Aspiro, Exela Pharma, Fresenius Kabi Usa, Hospira, Square Pharms Plc, Hq Spclt Pharma, Pharmobedient, Amneal, Gland, Milla Pharms, and Mylan Labs Ltd, and is included in twenty-one NDAs. It is available from twelve suppliers. Additional details are available on the MAGNESIUM SULFATE profile page.

The generic ingredient in MAGNESIUM SULFATE 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.

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	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	019316	NDA	Henry Schein, Inc.	0404-9902	0404-9902-20	1 VIAL, SINGLE-DOSE in 1 BAG (0404-9902-20) / 20 mL in 1 VIAL, SINGLE-DOSE
MAGNESIUM SULFATE	magnesium sulfate	SOLUTION;INTRAMUSCULAR, INTRAVENOUS	019316	NDA	Henry Schein, Inc.	0404-9904	0404-9904-02	1 VIAL, SINGLE-DOSE in 1 BAG (0404-9904-02) / 2 mL in 1 VIAL, SINGLE-DOSE

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAMUSCULAR, INTRAVENOUS			Strength	5GM/10ML (500MG/ML)
Approval Date:	Sep 8, 1986	TE:	AP	RLD:	Yes

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAMUSCULAR, INTRAVENOUS			Strength	1GM/2ML (500MG/ML)
Approval Date:	Sep 8, 1986	TE:	AP	RLD:	Yes

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAMUSCULAR, INTRAVENOUS			Strength	10GM/20ML (500MG/ML)
Approval Date:	Jan 29, 2016	TE:	AP	RLD:	Yes

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