ANDA 215737, held by Teva Pharms Inc. Cetrorelix Acetate.
As of Nov 15, 2026, ANDA 215737 (Cetrorelix Acetate), held by Teva Pharms Inc, was first approved by FDA on Aug 12, 2022, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 12, 2022 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cetrorelix AcetateEQ 0.25MG BASE/VIAL · powder;subcutaneous | Cetrorelix Acetate | Discontinued |
| Nov 6, 2025 | Supplement 3Labeling · Standard review | Approved | None posted |
| Nov 6, 2025 | Supplement 4Labeling · Standard review | Approved | None posted |
| Aug 12, 2022 | Original application | Approved |
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
