Data updated: Nov 8, 2026
PRAMIPEXOLE DIHYDROCHLORIDE · HERITAGE PHARMA AVET
CNS
Approved 1997-07-01
Pramipexole dihydrochloride extended-release tablets are indicated for the treatment of Parkinson's disease.
Source: FDA Label
25
Indications
--
Phase 3 Trials
29
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1997-07-01
- Routes
- ORAL
- Dosage Forms
- TABLET, TABLET, EXTENDED RELEASE
Companies
HERITAGE PHARMA AVET Teva MACLEODS PHARMS XIAMEN LP PHARM CO ALEMBIC Sun Pharma RISING ZYDUS PHARMS USA Novartis SCIEGEN PHARMS PHARMOBEDIENT GLENMARK PHARMS LTD CHARTWELL RX STRIDES PHARMA ZYDUS PHARMS NOVAST LABS Dr. Reddy's TORRENT PHARMS Aurobindo Pharma NATCO NATCO PHARMA LTD PH HEALTH UNICHEM
Active Ingredient: PRAMIPEXOLE DIHYDROCHLORIDE
Website: ↗
PRAMIPEXOLE DIHYDROCHLORIDE Approval History
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
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2025
2026
Original
New Indication
New Form
Label Update
1021 FDA actions from 2008 to 2026
Oct 2026 SUPPL
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Oct 2026 SUPPL
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Aug 2015 ORIGINAL
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Dec 2014 ORIGINAL
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Dec 2013 SUPPL
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Aug 2011 SUPPL
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Jun 2011 SUPPL
Mfg
Nov 2010 ORIGINAL
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Apr 2010 ORIGINAL
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Dec 2009 SUPPL
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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)
📋
Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT00893841 | D1443C00032 | Ph 2 | completed | Bipolar Study of Seroquel XR With Pramipexole Dihydrochloride |
🔬
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
Indications & Usage
Pramipexole dihydrochloride extended-release tablets are indicated for the treatment of Parkinson's disease. Pramipexole dihydrochloride extended-release tablet is a non-ergot dopamine agonist indicated for the treatment of Parkinson’s disease (PD)
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.