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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 020645

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NDA 020645 describes AMMONUL, which is a drug marketed by Bausch and is included in one NDA. Additional details are available on the AMMONUL profile page.

The generic ingredient in AMMONUL is sodium benzoate; sodium phenylacetate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the sodium benzoate; sodium phenylacetate profile page.

Summary for 020645

Tradename:	AMMONUL
Applicant:	Bausch
Ingredient:	sodium benzoate; sodium phenylacetate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS			Strength	10%;10% (5GM/50ML;5GM/50ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Feb 17, 2005	TE:		RLD:	Yes

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