Details for New Drug Application (NDA): 212789

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. It is available from one supplier. 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. Two suppliers are 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

Pharmacology for NDA: 212789

Mechanism of Action	Acidifying Activity Calcium Chelating Activity Magnesium Ion Exchange Activity Osmotic Activity
Physiological Effect	Decreased Coagulation Factor Activity 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: 212789

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACID	citric acid; magnesium oxide; sodium picosulfate	FOR SOLUTION;ORAL	212789	ANDA	Camber Pharmaceuticals, Inc.	31722-874	31722-874-16	2 PACKET in 1 CARTON (31722-874-16) / 16.1 g in 1 PACKET

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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