FDA ANDA · ANDA219737
FIDAXOMICIN
Sponsor: HIKMA
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APPLICATION
ANDA219737
TYPE
ANDA
ORIGINAL APPROVAL
2026-10-07
LATEST ACTION
2026-10-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
FIDAXOMICINPrescription
FIDAXOMICIN 200MG · TABLET · ORAL
Approval history
2026-10-07UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →