Details for New Drug Application (NDA): 213924

NDA 213924 describes SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE, which is a drug marketed by Alkem Labs Ltd, Annora Pharma, Bionpharma, Novel Labs Inc, Pai Holdings, Strides Pharma, and Taro, and is included in seven NDAs. It is available from five suppliers. Additional details are available on the SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE profile page.

The generic ingredient in SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE is magnesium sulfate; potassium sulfate; sodium sulfate. There are one hundred and forty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the magnesium sulfate; potassium sulfate; sodium sulfate profile page.

Summary for 213924

Tradename:	SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE
Applicant:	Alkem Labs Ltd
Ingredient:	magnesium sulfate; potassium sulfate; sodium sulfate
Patents:	0

Pharmacology for NDA: 213924

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

Suppliers and Packaging for NDA: 213924

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE	magnesium sulfate; potassium sulfate; sodium sulfate	SOLUTION;ORAL	213924	ANDA	Ascend Laboratories, LLC	67877-725	67877-725-92	2 BOTTLE, PLASTIC in 1 CARTON (67877-725-92) / 177 mL in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;ORAL			Strength	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT
Approval Date:	Dec 29, 2023	TE:	AA	RLD:	No

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