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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 050717

MONUROL (FOSFOMYCIN TROMETHAMINE)
EQ 3GM BASE/PACKET
Marketing Status: Prescription
Active Ingredient: FOSFOMYCIN TROMETHAMINE
Proprietary Name: MONUROL
Dosage Form; Route of Administration: FOR SOLUTION; ORAL
Strength: EQ 3GM BASE/PACKET
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AA
Application Number: N050717
Product Number: 001
Approval Date: Dec 19, 1996
Applicant Holder Full Name: ZAMBON SPA ITALY
Marketing Status:  Prescription
Patent and Exclusivity Information
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