Orange Book product · Generic (ANDA)
FIDAXOMICIN
FIDAXOMICIN
Generic (ANDA)ANDA 219559TE ABRX APOTEX
At a glance
Feb 02, 2026
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 02, 2026
5 mo ago
Today
Pharmaceutical detail
Active ingredient
FIDAXOMICIN
Strength
200MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 219559
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of FIDAXOMICIN
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.
