Data updated: May 26, 2026
SERZONE (nefazodone hydrochloride)
CNS
Approved 1994-12-22
2
Indications
--
Phase 3 Trials
1
Priority Reviews
31
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1994-12-22
- Routes
- ORAL
- Dosage Forms
- TABLET
SERZONE Approval History
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
216 FDA actions from 1994 to 2009
Mar 2009 SUPPL
Label · Labeling
Apr 2002 SUPPL
Mfg
Mar 2002 SUPPL
Mfg
Jan 2001 SUPPL
Label
Nov 2000 SUPPL
Mfg
Jul 2000 SUPPL
Label
Jun 2000 SUPPL
Label
Apr 2000 SUPPL
Mfg
Nov 1999 SUPPL
Mfg
Sep 1999 SUPPL
Mfg
Sep 1999 SUPPL
Label
Jan 1999 SUPPL
Mfg
Aug 1997 SUPPL
Label
May 1997 SUPPL
Label
Feb 1997 SUPPL
Mfg
Jan 1997 SUPPL
Mfg
Dec 1996 SUPPL
Mfg
Jun 1996 SUPPL
Label
Mar 1996 SUPPL
Mfg
Mar 1996 SUPPL
Mfg
Dec 1994 ORIGINAL
New Drug
What SERZONE Treats
2 FDA approvalsOriginally approved for its first indication in 1994 . Covers 2 distinct patient populations.
- Other (2)
Other
(2 approvals)- • Approved indication (Dec 1994)
- • Approved indication (Mar 2009) Priority
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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.
SERZONE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.