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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 050717

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NDA 050717 describes MONUROL, which is a drug marketed by Zambon Spa and is included in one NDA. Additional details are available on the MONUROL profile page.

The generic ingredient in MONUROL is fosfomycin tromethamine. There are six drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the fosfomycin tromethamine profile page.

Summary for 050717

Tradename:	MONUROL
Applicant:	Zambon Spa
Ingredient:	fosfomycin tromethamine
Patents:	0

Medical Subject Heading (MeSH) Categories for 050717

Anti-Bacterial Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SOLUTION;ORAL			Strength	EQ 3GM BASE/PACKET
Approval Date:	Dec 19, 1996	TE:		RLD:	Yes

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