TheraRadar
Data updated: Nov 8, 2026

CLONIDINE HYDROCHLORIDE · WATSON LABS

Generic · see JAVADIN
Cardiovascular Approved 1974-09-03

CLONIDINE HYDROCHLORIDE is FDA-approved to treat 4 conditions (same as DURACLON).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
26
Indications
--
Phase 3 Trials
52
Years on Market

Details

Status
Prescription
First Approved
1974-09-03
Routes
ORAL, INJECTION
Dosage Forms
TABLET, INJECTABLE, TABLET, EXTENDED RELEASE

Companies

WATSON LABS PAR PHARM PRINSTON INC XGEN PHARMS RUBICON RESEARCH Teva TP ANDA HOLDINGS INTERPHARM UNICHEM Sun Pharma AM THERAP IMPAX LABS ZYDUS PHARMS XIAMEN LP PHARM CO AMNEAL PHARMS NY WARNER CHILCOTT Fresenius Kabi DURAMED PHARMS BARR ALEMBIC PHARMS LTD Aurobindo Pharma Hikma PH HEALTH CHARTWELL MOLECULES CHARTWELL RX NOVAST LABS AM REGENT YUNG SHIN PHARM AJANTA PHARMA LTD JUBILANT GENERICS SOMERSET THERAPS LLC RISING
Active Ingredient: CLONIDINE HYDROCHLORIDE

CLONIDINE HYDROCHLORIDE Approval History

1987
1988
1989
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1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
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2015
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2019
2020
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2026
Original
New Indication
New Form
Label Update
336 FDA actions from 1986 to 2026
Nov 2026 SUPPL
Label · Labeling
Sep 2026 SUPPL
Mfg · Manufacturing (CMC)
Dec 2024 SUPPL
Mfg · Manufacturing (CMC)

What CLONIDINE HYDROCHLORIDE Treats

4 indications

CLONIDINE HYDROCHLORIDE is approved for 4 conditions since its original approval in 1986. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Cancer
  • Neuropathic Pain
  • Somatic Pain
  • Visceral Pain

Same approved indications as DURACLON (same active ingredient).

Source: FDA Label
📋

Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT01439126 results posted SHN-KAP-401 Ph 4 completed Efficacy & Safety of KAPVAY™ Extended-Release in Children & Adolescents With Attention Deficit Hyperactivity Disorder
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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

Indications & Usage

CLONIDINE HYDROCHLORIDE is FDA-approved to treat 4 conditions — same approved indications as DURACLON.

Looking for the branded version?

JAVADIN

Full clinical data, patents, trials, and competitive landscape for clonidine hydrochloride.

See JAVADIN

Data Sources

FDA Approval: ANDA070397 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.