ANDA 218150, held by Gland. Cetrorelix Acetate.
As of Nov 15, 2026, ANDA 218150 (Cetrorelix Acetate), held by Gland, was first approved by FDA on Apr 25, 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 25, 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
