ANDA 218740, held by Epic Pharma LLC. Cetrorelix Acetate.
As of Nov 15, 2026, ANDA 218740 (Cetrorelix Acetate), held by Epic Pharma LLC, was first approved by FDA on Apr 29, 2026, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 29, 2026 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cetrorelix AcetateEQ 0.25MG BASE/VIAL ยท powder;subcutaneous | Cetrorelix 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
