ANDA 214540, held by Livzon Grp. Cetrorelix Acetate.
As of Nov 15, 2026, ANDA 214540 (Cetrorelix Acetate), held by Livzon Grp, was first approved by FDA on Apr 24, 2024, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Cetrorelix Acetate for Injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian stimulation.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 24, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cetrorelix AcetateEQ 0.25MG BASE/VIAL · 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
