Data updated: Mar 10, 2026
TIZANIDINE HYDROCHLORIDE
TIZANIDINE HYDROCHLORIDE
Approved 2002-06-27
28
Indications
--
Phase 3 Trials
23
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2002-06-27
- Routes
- ORAL
- Dosage Forms
- TABLET, CAPSULE
Companies
ANI PHARMS Sun Pharma PH HEALTH ZYDUS PHARMS SENORES PHARMS CADILA PHARMS LTD JUBILANT GENERICS INGENUS PHARMS LLC ALKEM LABS LTD Aurobindo Pharma RISING PHARMOBEDIENT Dr. Reddy's CHARTWELL RX Apotex ALEMBIC RUBICON RESEARCH EPIC PHARMA LLC UNICHEM LABS LTD OXFORD PHARMS CADILA
Active Ingredient: TIZANIDINE HYDROCHLORIDE
Website: ↗
TIZANIDINE HYDROCHLORIDE Approval History
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What TIZANIDINE HYDROCHLORIDE Treats
28 FDA approvalsOriginally approved for its first indication in 2002 . Covers 28 distinct patient populations.
- Other (28)
Other
(28 approvals)- • Approved indication (Jun 2002)
- • Approved indication (Jul 2002)
- • Approved indication (Jul 2002)
- • Approved indication (Oct 2002)
- • Approved indication (Mar 2003)
- • Approved indication (Apr 2003)
- • Approved indication (Sep 2003)
- • Approved indication (Oct 2003)
- • Approved indication (Dec 2003)
- • Approved indication (Jan 2004)
- • Approved indication (Sep 2004)
- • Approved indication (Feb 2012)Letter
- • Approved indication (Nov 2012)
- • Approved indication (Nov 2012)
- • Approved indication (Jan 2017)
- • Approved indication (Mar 2017)
- • Approved indication (Mar 2017)
- • Approved indication (Aug 2017)
- • Approved indication (Mar 2018)
- • Approved indication (Jan 2019)
- • Approved indication (Mar 2019)
- • Approved indication (Mar 2019)
- • Approved indication (Mar 2019)
- • Approved indication (Jan 2020)
- • Approved indication (Mar 2020)
- • Approved indication (May 2020)
- • Approved indication (May 2024)
- • Approved indication (Aug 2024)
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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.
TIZANIDINE 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.