← FDA Drug Approvals (Drugs@FDA)
FIDAXOMICIN
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HIKMA · Approved 2026-10-07
Drug application
- FDA Application #
ANDA219737- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- FIDAXOMICIN
- Generic name
- Fidaxomicin
- Active ingredients
- FIDAXOMICIN
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- HIKMA
- First approval
- 2026-10-07
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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