ANDA 220919, held by Qilu Pharm Hainan. Difelikefalin Acetate.
As of Nov 15, 2026, ANDA 220919 (Difelikefalin Acetate), held by Qilu Pharm Hainan, was first approved by FDA on Aug 31, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 31, 2026 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Difelikefalin AcetateEQ 0.065MG BASE/1.3ML (EQ 0.05MG BASE/ML) ยท solution;intravenous | Difelikefalin Acetate | Rx |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
