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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 212789

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NDA 212789 describes SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID, which is a drug marketed by Hetero Labs Ltd V and is included in one NDA. Additional details are available on the SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID profile page.

The generic ingredient in SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID is citric acid; magnesium oxide; sodium picosulfate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the citric acid; magnesium oxide; sodium picosulfate profile page.

Summary for 212789

Tradename:	SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID
Applicant:	Hetero Labs Ltd V
Ingredient:	citric acid; magnesium oxide; sodium picosulfate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	FOR SOLUTION;ORAL			Strength	12GM/PACKET;3.5GM/PACKET;10MG/PACKET
Approval Date:	Jul 18, 2022	TE:		RLD:	No

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