Orange Book product · Brand (NDA)
MONUROL
FOSFOMYCIN TROMETHAMINE
At a glance
Dec 19, 1996
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 19, 1996
29 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
FOSFOMYCIN TROMETHAMINE
Strength
EQ 3GM BASE/PACKET **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
FOR SOLUTION
Route
ORAL
TE code
Not listed
Application
NDA 050717
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2026FOSFOMYCIN TROMETHAMINEGeneric (ANDA)
ANDA 217772 · AUCTA
- 2025FOSFOMYCIN TROMETHAMINEGeneric (ANDA)
ANDA 217608 · AUROBINDO PHARMA LTD
- 2025FOSFOMYCIN TROMETHAMINEGeneric (ANDA)
ANDA 217187 · PRECISION DOSE INC
- 2024FOSFOMYCIN TROMETHAMINEGeneric (ANDA)
ANDA 216600 · AMNEAL
- 2022FOSFOMYCIN TROMETHAMINEGeneric (ANDA)
ANDA 211881 · CIPLA
- 2021FOSFOMYCIN TROMETHAMINEGeneric (ANDA)
ANDA 214554 · ALKEM LABS LTD
- 2020FOSFOMYCIN TROMETHAMINEGeneric (ANDA)
ANDA 212548 · XIROMED
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.
