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Last Updated: July 7, 2020

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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. It is available from one supplier. 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. One supplier is listed for this compound. Additional details are available on the fosfomycin tromethamine profile page.
Summary for 050717
Applicant:Zambon Spa
Ingredient:fosfomycin tromethamine
Medical Subject Heading (MeSH) Categories for 050717
Suppliers and Packaging for NDA: 050717
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MONUROL fosfomycin tromethamine FOR SOLUTION;ORAL 050717 NDA Allergan, Inc. 0456-4300 0456-4300-01 1 DOSE PACK in 1 CARTON (0456-4300-01) > 1 POWDER in 1 DOSE PACK
MONUROL fosfomycin tromethamine FOR SOLUTION;ORAL 050717 NDA Allergan, Inc. 0456-4300 0456-4300-08 1 POWDER in 1 PACKET (0456-4300-08)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SOLUTION;ORALStrengthEQ 3GM BASE/PACKET
Approval Date:Dec 19, 1996TE:RLD:Yes

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