FDA Orange Book · active-ingredient family
Fosfomycin tromethamine
Fosfomycin tromethamine is approved as 1 brand and 7 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:MONUROL · NDA 050717
1
Brand (NDA)
7
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · for solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MONUROLRLD | ZAMBON SPA | NDA 050717 | — | Dec 19, 1996 |
Generic (ANDA) products (7)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| FOSFOMYCIN TROMETHAMINE | AUCTA | ANDA 217772 | AA | Apr 09, 2026 | |
| FOSFOMYCIN TROMETHAMINE | AUROBINDO PHARMA LTD | ANDA 217608 | AA | Nov 14, 2025 | |
| FOSFOMYCIN TROMETHAMINE | PRECISION DOSE INC | ANDA 217187 | AA | Jun 03, 2025 | |
| FOSFOMYCIN TROMETHAMINE | AMNEAL | ANDA 216600 | AA | Mar 25, 2024 | |
| FOSFOMYCIN TROMETHAMINE | CIPLA | ANDA 211881 | AA | Jan 26, 2022 | |
| FOSFOMYCIN TROMETHAMINE | ALKEM LABS LTD | ANDA 214554 | AA | Oct 21, 2021 | |
| FOSFOMYCIN TROMETHAMINE | XIROMED | ANDA 212548 | AA | Oct 06, 2020 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Fosfomycin tromethamine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
