ANDA 204735, held by Ingenus Pharms LLC. Cabergoline.
As of Nov 13, 2026, ANDA 204735 (Cabergoline), held by Ingenus Pharms LLC, was first approved by FDA on Aug 1, 2018, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 1, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Cabergoline0.5MG · tablet;oral | Cabergoline | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 11, 2025 | Supplement 6Labeling · Standard review | Approved | None posted |
| Dec 13, 2019 | Supplement 1Labeling · Standard review | Approved | None posted |
| Aug 1, 2018 | Original application | Approved | None posted |
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
