Data updated: Mar 10, 2026
TRAZODONE HYDROCHLORIDE
TRAZODONE HYDROCHLORIDE
Approved 1986-10-10
18
Indications
--
Phase 3 Trials
39
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1986-10-10
- Routes
- ORAL
- Dosage Forms
- TABLET
Companies
WATSON LABS Sun Pharma GRAVITI PHARMS USL PHARMA Apotex OXFORD PHARMS AM THERAP NATCO ALVOGEN AIPING PHARM INC ACCORD HLTHCARE Teva PHARMOBEDIENT Aurobindo Pharma RISING TORRENT CROSSMEDIKA SA ZYDUS PHARMS GRANULES QUANTUM PHARMICS PLIVA
Active Ingredient: TRAZODONE HYDROCHLORIDE
Website: ↗
TRAZODONE HYDROCHLORIDE Approval History
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What TRAZODONE HYDROCHLORIDE Treats
18 FDA approvalsOriginally approved for its first indication in 1986 . Covers 18 distinct patient populations.
- Other (18)
Other
(18 approvals)- • Approved indication (Oct 1986)
- • Approved indication (Mar 1987)
- • Approved indication (Dec 1987)
- • Approved indication (Mar 1988)
- • Approved indication (Apr 1988)
- • Approved indication (Feb 1989)
- • Approved indication (Apr 1990)
- • Approved indication (Feb 1991)
- • Approved indication (Mar 1993)
- • Approved indication (Apr 1997)
- • Approved indication (Jun 2009)
- • Approved indication (Nov 2013)
- • Approved indication (Sep 2017)
- • Approved indication (Oct 2017)
- • Approved indication (Feb 2020)
- • Approved indication (May 2024)
- • Approved indication (Aug 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.
TRAZODONE 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.