Data updated: Sep 20, 2026
ROPINIROLE HYDROCHLORIDE · Hikma
CNS
Approved 1997-09-19
16
Indications
--
Phase 3 Trials
29
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1997-09-19
- Routes
- ORAL
- Dosage Forms
- TABLET, TABLET, EXTENDED RELEASE
ROPINIROLE HYDROCHLORIDE Approval History
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
690 FDA actions from 2008 to 2026
Sep 2026 SUPPL
Label · Labeling
Jan 2026 SUPPL
Label · Labeling
Nov 2025 SUPPL
Label · Labeling
Nov 2025 ORIGINAL
Update
Sep 2025 SUPPL
Label
Sep 2025 SUPPL
Label
Mar 2025 SUPPL
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Mar 2025 SUPPL
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May 2024 SUPPL
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Apr 2024 SUPPL
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Nov 2023 SUPPL
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Oct 2022 SUPPL
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Oct 2022 SUPPL
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Oct 2022 SUPPL
Label
May 2022 ORIGINAL
Update
Mar 2021 SUPPL
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Dec 2020 SUPPL
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Dec 2020 SUPPL
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Aug 2020 SUPPL
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Aug 2020 SUPPL
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Apr 2020 SUPPL
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Apr 2020 SUPPL
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Apr 2020 SUPPL
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Apr 2020 SUPPL
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Mar 2020 SUPPL
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Feb 2020 SUPPL
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Feb 2017 ORIGINAL
Update
Jan 2016 SUPPL
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Dec 2015 SUPPL
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Nov 2015 SUPPL
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Nov 2015 SUPPL
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Oct 2015 SUPPL
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Oct 2015 SUPPL
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Oct 2015 SUPPL
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Sep 2015 SUPPL
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Sep 2015 SUPPL
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Apr 2015 SUPPL
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Aug 2013 SUPPL
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Apr 2013 ORIGINAL
Update
Jan 2013 SUPPL
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Nov 2012 ORIGINAL
Update
Oct 2012 ORIGINAL
Update
Sep 2012 SUPPL
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Aug 2012 ORIGINAL
Update
Jun 2012 ORIGINAL
Update
May 2012 ORIGINAL
Update
Feb 2012 SUPPL
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Feb 2012 SUPPL
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Feb 2012 ORIGINAL
Update
Nov 2011 SUPPL
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Oct 2011 SUPPL
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Aug 2011 SUPPL
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Apr 2010 SUPPL
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Mar 2010 ORIGINAL
Update
Feb 2010 ORIGINAL
Update
Nov 2009 SUPPL
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Nov 2009 SUPPL
Label
Jun 2009 ORIGINAL
Update
Jul 2008 SUPPL
Label
May 2008 ORIGINAL
Update
May 2008 SUPPL
Label
May 2008 ORIGINAL
Update
May 2008 SUPPL
Label
May 2008 ORIGINAL
Update
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.