# DIFELIKEFALIN ACETATE
> **ANDA220919** · Abbreviated New Drug Application (Generic) · Sponsor: QILU PHARM HAINAN · Approved 2026-08-31
## Drug
- **FDA Application Number:** ANDA220919
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** DIFELIKEFALIN ACETATE
- **Generic name:** Difelikefalin Acetate
- **Active ingredients:** DIFELIKEFALIN ACETATE
- **Dosage form:** SOLUTION
- **Route:** INTRAVENOUS
- **Marketing status:** Prescription
- **Sponsor:** QILU PHARM HAINAN
- **First approval:** 2026-08-31
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220919)
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