Data updated: Mar 10, 2026
CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE
Approved 1988-02-29
23
Indications
--
Phase 3 Trials
38
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1988-02-29
- Routes
- ORAL
- Dosage Forms
- CAPSULE, EXTENDED RELEASE, TABLET
Companies
Apotex OXFORD PHARMS Aurobindo Pharma PAR PHARM INC JUBILANT CADISTA NOVAST LABS PLIVA WATSON LABS RISING AIPING PHARM INC PRINSTON INC TWI PHARMS INC MACLEODS PHARMS LTD RUBICON RESEARCH UNICHEM TP ANDA HOLDINGS KVK TECH CHARTWELL RX Sun Pharma INVAGEN PHARMS Teva Novartis
Active Ingredient: CYCLOBENZAPRINE HYDROCHLORIDE
Website: ↗
CYCLOBENZAPRINE HYDROCHLORIDE Approval History
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What CYCLOBENZAPRINE HYDROCHLORIDE Treats
23 FDA approvalsOriginally approved for its first indication in 1988 . Covers 23 distinct patient populations.
- Other (23)
Other
(23 approvals)- • Approved indication (Feb 1988)
- • Approved indication (May 1991)
- • Approved indication (Nov 1991)
- • Approved indication (Nov 1991)
- • Approved indication (Feb 1993)
- • Approved indication (Nov 1994)
- • Approved indication (May 1995)
- • Approved indication (Sep 1995)
- • Approved indication (Oct 2005)
- • Approved indication (Apr 2006)
- • Approved indication (Feb 2007)
- • Approved indication (Apr 2008)
- • Approved indication (May 2008)
- • Approved indication (Sep 2008)
- • Approved indication (Jul 2010)
- • Approved indication (Feb 2011)
- • Approved indication (Jan 2013)
- • Approved indication (May 2017)
- • Approved indication (Jul 2018)
- • Approved indication (Jul 2020)
- • Approved indication (Jul 2024)
- • Approved indication (Aug 2024)
- • Approved indication (Sep 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.
CYCLOBENZAPRINE 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.