Orange Book product · Generic (ANDA)
FIDAXOMICIN
FIDAXOMICIN
Generic (ANDA)ANDA 208443TE ABRX ACTAVIS LABS FL
At a glance
Jan 16, 2024
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 16, 2024
2 yr 6 mo ago
Today
Pharmaceutical detail
Active ingredient
FIDAXOMICIN
Strength
200MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 208443
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.
