Orange Book product · Generic (ANDA)
FOSFOMYCIN TROMETHAMINE
FOSFOMYCIN TROMETHAMINE
At a glance
Nov 14, 2025
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 14, 2025
7 mo ago
Today
Pharmaceutical detail
Active ingredient
FOSFOMYCIN TROMETHAMINE
Strength
EQ 3GM BASE/PACKET
Dosage form
FOR SOLUTION
Route
ORAL
TE code
AA
Application
ANDA 217608
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of FOSFOMYCIN TROMETHAMINE
- 1996MONUROLBrand (NDA)
NDA 050717 · ZAMBON SPA
- 2026FOSFOMYCIN TROMETHAMINEGeneric (ANDA)
ANDA 217772 · AUCTA
- 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.
