Data updated: Mar 10, 2026
PRAMIPEXOLE DIHYDROCHLORIDE
PRAMIPEXOLE DIHYDROCHLORIDE
Approved 2008-02-19
25
Indications
--
Phase 3 Trials
18
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2008-02-19
- Routes
- ORAL
- Dosage Forms
- TABLET, TABLET, EXTENDED RELEASE
Companies
NATCO PHARMOBEDIENT Aurobindo Pharma MACLEODS PHARMS LTD UNICHEM XIAMEN LP PHARM CO HERITAGE PHARMA AVET CHARTWELL RX GLENMARK PHARMS LTD PH HEALTH ALEMBIC ZYDUS PHARMS USA INC TORRENT PHARMS Teva STRIDES PHARMA Dr. Reddy's SCIEGEN PHARMS RISING NOVAST LABS Novartis Sun Pharma NATCO PHARMA ZYDUS PHARMS
Active Ingredient: PRAMIPEXOLE DIHYDROCHLORIDE
Website: ↗
PRAMIPEXOLE DIHYDROCHLORIDE Approval History
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What PRAMIPEXOLE DIHYDROCHLORIDE Treats
25 FDA approvalsOriginally approved for its first indication in 2008 . Covers 25 distinct patient populations.
- Other (25)
Other
(25 approvals)- • Approved indication (Feb 2008)Letter
- • Approved indication (Apr 2010)
- • Approved indication (Jul 2010)
- • Approved indication (Oct 2010)
- • Approved indication (Nov 2010)
- • Approved indication (Apr 2012)
- • Approved indication (Sep 2012)
- • Approved indication (Oct 2012)
- • Approved indication (Mar 2013)
- • Approved indication (Feb 2014)
- • Approved indication (Jun 2014)
- • Approved indication (Oct 2014)
- • Approved indication (Dec 2014)
- • Approved indication (Aug 2015)
- • Approved indication (Apr 2016)
- • Approved indication (Jun 2016)
- • Approved indication (Oct 2016)
- • Approved indication (Jan 2017)
- • Approved indication (Jan 2017)
- • Approved indication (Dec 2017)
- • Approved indication (Oct 2018)
- • Approved indication (Dec 2018)
- • Approved indication (Jan 2019)
- • Approved indication (Jun 2021)
- • Approved indication (Feb 2022)
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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.
PRAMIPEXOLE DIHYDROCHLORIDE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.