Orange Book product · Generic (ANDA)
FOSFOMYCIN TROMETHAMINE
FOSFOMYCIN TROMETHAMINE
At a glance
Oct 06, 2020
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 06, 2020
5 yr 9 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 212548
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
Yes
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 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
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.
