Treats hyperprolactinemic disorders. Sold as Dostinex. Every FDA application for this active ingredient: 1 branded and 10 generic.
As of Nov 13, 2026, FDA lists 11 applications for Cabergoline (sold as Dostinex), first approved Dec 23, 1996, with 1 new use approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Cabergoline | Part D | $6.9M | +2% | 23,595 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Dec 23, 1996 | DostinexNDA 20664 ยท New molecular entity | Pfizer | 14 | Discontinued |
| Dec 29, 2005 | CabergolineANDA 76310 | Strides Pharma Intl | 5 | Marketed |
| Mar 7, 2007 | CabergolineANDA 77750 | Ivax Sub Teva Pharms | 6 | Marketed |
| Jul 3, 2007 | CabergolineANDA 77843 | Impax Labs Inc | 3 | Discontinued |
| Apr 21, 2008 | CabergolineANDA 78035 | Actavis Labs Fl Inc | 4 | Discontinued |
| Mar 8, 2013 | CabergolineANDA 201503 | Apotex Corp | 0 | Discontinued |
| Dec 2, 2013 | CabergolineANDA 202947 | Pharmobedient | 2 | Discontinued |
| Aug 1, 2018 | CabergolineANDA 204735 | Ingenus Pharms LLC | 2 | Marketed |
| Jun 25, 2024 | CabergolineANDA 218618 | Amneal | 0 | Marketed |
| Sep 9, 2024 | CabergolineANDA 218109 | Somerset Theraps LLC | 0 | Marketed |
| Jun 15, 2026 | CabergolineANDA 220309 | Renata | 0 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number. Drugs@FDA
Pfizer