fosfomycin tromethamine · Zambon Spa · NDA 050717
Monurol
Earliest generic entry, as listed
Open now
No marketed reference-listed strength; date taken from all listed strengths.
No unexpired patents or exclusivities are listed for this product.
Listed patents · 0 unexpired
No unexpired patents listed.
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- Generic approved · ANDA 217608, Aurobindo Pharma Ltd · 050717-001Approved 14 Nov 2025Detected 25 Oct 2026Historical import
- Generic approved · ANDA 217772, Aucta · 050717-001Approved 9 Apr 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 210426, Novitium Pharma · 050717-001Approved 12 Aug 2026Detected 25 Oct 2026Historical import
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 050717 · 001 · RLD · discontinued | for solution, oral | EQ 3GM BASE/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |