Details for New Drug Application (NDA): 215469

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NDA 215469 describes SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE, which is a drug marketed by Alkem Labs Ltd, Annora Pharma, Bionpharma, Macleods Pharms Ltd, Novel Labs Inc, Pai Holdings, Strides Pharma Intl, and Taro, and is included in eight NDAs. It is available from nine 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 is one drug master file entry for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the magnesium sulfate; potassium sulfate; sodium sulfate profile page.

Summary for 215469

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

Pharmacology for NDA: 215469

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: 215469

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	215469	ANDA	Strides Pharma Science Limited	64380-116	64380-116-01	2 BOTTLE in 1 CARTON (64380-116-01) / 177 mL in 1 BOTTLE (64380-116-02)

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:	Nov 22, 2023	TE:	AA	RLD:	No

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