Data updated: Mar 10, 2026
CLONIDINE HYDROCHLORIDE
CLONIDINE HYDROCHLORIDE
Approved 1986-07-01
26
Indications
--
Phase 3 Trials
39
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1986-07-01
- Routes
- ORAL, INJECTION
- Dosage Forms
- TABLET, EXTENDED RELEASE, TABLET, INJECTABLE
Companies
AMNEAL PHARMS NY Teva INTERPHARM PRINSTON INC Sun Pharma ZYDUS PHARMS XIAMEN LP PHARM CO PAR PHARM WATSON LABS XGEN PHARMS CHARTWELL MOLECULES PH HEALTH AM THERAP DURAMED PHARMS BARR WARNER CHILCOTT UNICHEM JUBILANT GENERICS AM REGENT Fresenius Kabi CHARTWELL RX Hikma SOMERSET THERAPS LLC Aurobindo Pharma ALEMBIC PHARMS LTD NOVAST LABS RISING TP ANDA HOLDINGS IMPAX LABS YUNG SHIN PHARM AJANTA PHARMA LTD RUBICON RESEARCH
Active Ingredient: CLONIDINE HYDROCHLORIDE
Website: ↗
CLONIDINE HYDROCHLORIDE Approval History
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What CLONIDINE HYDROCHLORIDE Treats
26 FDA approvalsOriginally approved for its first indication in 1986 . Covers 26 distinct patient populations.
- Other (26)
Other
(26 approvals)- • Approved indication (Jul 1986)
- • Approved indication (Dec 1986)
- • Approved indication (Jun 1987)
- • Approved indication (Sep 1987)
- • Approved indication (Apr 1988)
- • Approved indication (Aug 1988)
- • Approved indication (Mar 2007)
- • Approved indication (Aug 2009)
- • Approved indication (Aug 2009)
- • Approved indication (Oct 2009)
- • Approved indication (Jan 2011)
- • Approved indication (Jul 2011)
- • Approved indication (Dec 2011)
- • Approved indication (Jun 2013)
- • Approved indication (Sep 2013)Letter
- • Approved indication (Oct 2013)
- • Approved indication (Feb 2014)
- • Approved indication (Apr 2014)
- • Approved indication (Jul 2014)
- • Approved indication (May 2015)
- • Approved indication (Oct 2017)
- • Approved indication (Nov 2017)
- • Approved indication (Jan 2018)
- • Approved indication (Apr 2018)
- • Approved indication (Oct 2018)
- • Approved indication (Mar 2019)
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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.
CLONIDINE 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.