Data updated: Mar 10, 2026
ROPINIROLE HYDROCHLORIDE
ROPINIROLE HYDROCHLORIDE
Approved 2008-05-05
16
Indications
--
Phase 3 Trials
17
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2008-05-05
- Routes
- ORAL
- Dosage Forms
- TABLET, TABLET, EXTENDED RELEASE
Companies
EPIC PHARMA LLC ACCORD HLTHCARE MLV Teva Dr. Reddy's PRINSTON INC ORBION PHARMS ALEMBIC Hikma ALEMBIC LTD WATSON LABS INC CHARTWELL RX ZYDUS LIFESCIENCES COSETTE PHARMOBEDIENT Novartis GLENMARK PHARMS LTD Aurobindo Pharma ELITE LABS INC
Active Ingredient: ROPINIROLE HYDROCHLORIDE
Website: ↗
ROPINIROLE HYDROCHLORIDE Approval History
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What ROPINIROLE HYDROCHLORIDE Treats
16 FDA approvalsOriginally approved for its first indication in 2008 . Covers 16 distinct patient populations.
- Other (16)
Other
(16 approvals)- • Approved indication (May 2008)
- • Approved indication (May 2008)
- • Approved indication (May 2008)
- • Approved indication (Jun 2009)
- • Approved indication (Feb 2010)
- • Approved indication (Mar 2010)
- • Approved indication (Feb 2012)
- • Approved indication (May 2012)
- • Approved indication (Jun 2012)
- • Approved indication (Aug 2012)
- • Approved indication (Oct 2012)
- • Approved indication (Nov 2012)
- • Approved indication (Apr 2013)
- • Approved indication (Feb 2017)
- • Approved indication (May 2022)
- • Approved indication (Nov 2025) New
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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.
ROPINIROLE HYDROCHLORIDE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.