ANDA 218109, held by Somerset Theraps LLC. Cabergoline.
As of Nov 13, 2026, ANDA 218109 (Cabergoline), held by Somerset Theraps LLC, was first approved by FDA on Sep 9, 2024, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 9, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cabergoline0.5MG ยท tablet;oral | Cabergoline | 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
