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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 079247

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NDA 079247 describes MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE, which is a drug marketed by Novel Labs Inc and is included in one NDA. Additional details are available on the MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE profile page.

The generic ingredient in MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE is sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Additional details are available on the sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate profile page.

Summary for 079247

Tradename:	MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE
Applicant:	Novel Labs Inc
Ingredient:	sodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate
Patents:	0

Pharmacology for NDA: 079247

Mechanism of Action	Osmotic Activity
Physiological Effect	Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	0.398GM;1.102GM
Approval Date:	Dec 30, 2011	TE:		RLD:	No

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