Application 050717
- Type
- NDA
- Sponsor
- ZAMBON SPA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MONUROL | FOSFOMYCIN TROMETHAMINE | FOR SOLUTION;ORAL | EQ 3GM BASE/PACKET | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N050717-001 | MONUROL | FOSFOMYCIN TROMETHAMINE | EQ 3GM BASE/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | RLD | 1996-12-19 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | N050717-001 | MONUROL | EQ 3GM BASE/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SOLUTION / ORAL | RLD | 1996-12-19 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Fosfomycin Tromethamine | FOSFOMYCIN TROMETHAMINE | Aucta Pharmaceuticals, Inc. | 4f206750-8126-99a3-e063-6294a90ade4c | 2026-04-09 | Warnings, Adverse reactions | FOSFOMYCIN TROMETHAMINE |
| Fosfomycin Tromethamine | FOSFOMYCIN TROMETHAMINE | Precision Dose, Inc. | f44b79d0-a789-46cb-ab70-7eb33a7debaf | 2025-12-23 | Warnings, Adverse reactions | FOSFOMYCIN TROMETHAMINE |
| Fosfomycin Tromethamine | FOSFOMYCIN TROMETHAMINE | Ascend Laboratories, LLC | 48e352bc-52ea-4778-905a-60ef38a5c18a | 2025-12-17 | Warnings, Adverse reactions | FOSFOMYCIN TROMETHAMINE |
| Fosfomycin tromethamine | FOSFOMYCIN TROMETHAMINE | Aurobindo Pharma Limited | f8ec4771-3f8d-473a-a1d0-e42038f61a42 | 2025-11-17 | Warnings, Adverse reactions | FOSFOMYCIN TROMETHAMINE |
| Fosfomycin Tromethamine | FOSFOMYCIN TROMETHAMINE | Kesin Pharma Corporation | 3fa61bd4-fc55-0987-e063-6394a90abce2 | 2025-09-25 | Warnings, Adverse reactions | FOSFOMYCIN TROMETHAMINE |
| FOSFOMYCIN TROMETHAMINE | FOSFOMYCIN TROMETHAMINE | Cipla USA Inc. | d101b5d8-bffc-4ee6-b93b-4589fcb8750d | 2025-03-17 | Warnings, Adverse reactions | FOSFOMYCIN TROMETHAMINE |
| Fosfomycin Tromethamine | FOSFOMYCIN TROMETHAMINE | Amneal Pharmaceuticals NY LLC | aacd04a4-f2d5-45a2-b9e7-0e92244a5880 | 2024-04-02 | Warnings, Adverse reactions | FOSFOMYCIN TROMETHAMINE |
| Fosfomycin Tromethamine | FOSFOMYCIN TROMETHAMINE | A-S Medication Solutions | 6b9167a9-80e9-44e1-a609-c3eb78960acf | 2023-11-01 | Warnings, Adverse reactions | FOSFOMYCIN TROMETHAMINE |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0456-4300 | Monurol | Fosfomycin tromethamine | Allergan, Inc. | NDA | Current |
| 0456-4300 | Monurol | Fosfomycin tromethamine | Allergan, Inc. | NDA | Current |
| 0456-4300 | Monurol | Fosfomycin tromethamine | Allergan, Inc. | NDA | Current |
| 82036-4274 | Fosfomycin Tromethamine | Fosfomycin Tromethamine | Zambon USA, Ltd | NDA AUTHORIZED GENERIC | Current |
| 82036-4274 | Fosfomycin Tromethamine | Fosfomycin Tromethamine | Zambon USA, Ltd | NDA AUTHORIZED GENERIC | Current |
| 82036-4274 | Fosfomycin Tromethamine | Fosfomycin Tromethamine | Zambon USA, Ltd | NDA AUTHORIZED GENERIC | Current |