Details for New Drug Application (NDA): 216597

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NDA 216597 describes MAGNESIUM SULFATE IN PLASTIC CONTAINER, which is a drug marketed by Amneal, Baxter Hlthcare Corp, Fresenius Kabi Usa, Gland Pharma Ltd, Hospira, Hq Spclt Pharma, Milla Pharms, and Mylan Labs Ltd, 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 are one hundred and forty-six drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the magnesium sulfate profile page.

Tradename:	MAGNESIUM SULFATE IN PLASTIC CONTAINER
Applicant:	Amneal
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 PLASTIC CONTAINER	magnesium sulfate	INJECTABLE;INJECTION	216597	ANDA	Amneal Pharmaceuticals LLC	70121-1719	70121-1719-2	15 POUCH in 1 CARTON (70121-1719-2) / 1 BAG in 1 POUCH / 50 mL in 1 BAG
MAGNESIUM SULFATE IN PLASTIC CONTAINER	magnesium sulfate	INJECTABLE;INJECTION	216597	ANDA	Amneal Pharmaceuticals LLC	70121-1719	70121-1719-9	24 POUCH in 1 CARTON (70121-1719-9) / 1 BAG in 1 POUCH / 50 mL in 1 BAG

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	2GM/50ML (40MG/ML)
Approval Date:	Feb 15, 2023	TE:	AP	RLD:	No

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	4GM/100ML (40MG/ML)
Approval Date:	Feb 15, 2023	TE:	AP	RLD:	No

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