# FIDAXOMICIN
> **ANDA220465** · Abbreviated New Drug Application (Generic) · Sponsor: SANDOZ · Approved 2026-08-13
## Drug
- **FDA Application Number:** ANDA220465
- **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:** SANDOZ
- **Manufacturer:** Sandoz Inc
- **First approval:** 2026-08-13
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220465)
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