ANDA 215574, held by Hetero Labs Ltd V. Ospemifene.
As of Nov 14, 2026, ANDA 215574 (Ospemifene), held by Hetero Labs Ltd V, was first approved by FDA on Feb 13, 2024, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 13, 2024 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ospemifene60MG · tablet;oral | Ospemifene | Discontinued |
| Jul 25, 2025 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jul 24, 2024 | Supplement 1Labeling · Standard review | Approved | None posted |
| Feb 13, 2024 | 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
