Data updated: Mar 10, 2026
CABERGOLINE
CABERGOLINE
Approved 2005-12-29
9
Indications
--
Phase 3 Trials
20
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2005-12-29
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
PHARMOBEDIENT IVAX SUB TEVA PHARMS INGENUS PHARMS LLC Teva Apotex STRIDES PHARMA INTL SOMERSET THERAPS LLC IMPAX LABS INC AMNEAL
Active Ingredient: CABERGOLINE
Website: ↗
CABERGOLINE Approval History
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What CABERGOLINE Treats
9 FDA approvalsOriginally approved for its first indication in 2005 . Covers 9 distinct patient populations.
- Other (9)
Other
(9 approvals)- • Approved indication (Dec 2005)Letter
- • Approved indication (Mar 2007)
- • Approved indication (Jul 2007)
- • Approved indication (Apr 2008)
- • Approved indication (Mar 2013)
- • Approved indication (Dec 2013)
- • Approved indication (Aug 2018)
- • Approved indication (Jun 2024)
- • Approved indication (Sep 2024)
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
CABERGOLINE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.