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. Six suppliers are listed for this compound. Additional details are available on the fosfomycin tromethamine 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
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 AUTHORIZED GENERIC | Zambon USA, Ltd | 82036-4274 | 82036-4274-1 | 1 DOSE PACK in 1 CARTON (82036-4274-1) / 1 POWDER in 1 DOSE PACK |
| MONUROL | fosfomycin tromethamine | FOR SOLUTION;ORAL | 050717 | NDA AUTHORIZED GENERIC | Zambon USA, Ltd | 82036-4274 | 82036-4274-8 | 1 POWDER in 1 PACKET (82036-4274-8) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SOLUTION;ORAL | Strength | EQ 3GM BASE/PACKET | ||||
| Approval Date: | Dec 19, 1996 | TE: | AA | RLD: | Yes | ||||
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