Details for New Drug Application (NDA): 206431

NDA 206431 describes SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE, which is a drug marketed by Alkem Labs Ltd, Bionpharma, Novel Labs Inc, Pai Holdings, Strides Pharma, and Taro, and is included in six 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 206431

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

Pharmacology for NDA: 206431

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: 206431

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	206431	ANDA	Taro Pharmaceuticals U.S.A., inc.	51672-4170	51672-4170-5	2 BOTTLE in 1 CARTON (51672-4170-5) / 177 mL in 1 BOTTLE

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:	Mar 19, 2024	TE:	AA	RLD:	No

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