Data updated: May 26, 2026
MOBAN (molindone hydrochloride)
CNS
Approved 1974-01-18
2
Indications
--
Phase 3 Trials
52
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1974-01-18
- Routes
- ORAL
- Dosage Forms
- TABLET, CAPSULE, CONCENTRATE
MOBAN Approval History
1975
1976
1977
1978
1979
1980
1981
1982
1983
1984
1985
1986
1987
1988
1989
1990
1991
1992
1993
1994
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
309 FDA actions from 1974 to 2025
Jan 2002 SUPPL
Mfg
Aug 1998 SUPPL
Mfg
Apr 1996 SUPPL
Mfg
Aug 1995 SUPPL
Mfg
Aug 1994 SUPPL
Mfg
Aug 1988 SUPPL
Mfg
Jun 1988 SUPPL
Mfg
Sep 1987 SUPPL
Mfg
Jun 1986 SUPPL
Mfg
Jun 1985 SUPPL
Mfg
Jun 1984 SUPPL
Mfg
Nov 1982 SUPPL
Label
Nov 1981 SUPPL
Mfg
Mar 1981 SUPPL
Label
Jan 1981 SUPPL
Mfg
Jan 1981 SUPPL
Mfg
Dec 1979 ORIGINAL
New Form
Dec 1979 SUPPL
Mfg
Sep 1979 SUPPL
Mfg
Aug 1979 SUPPL
Label
May 1979 SUPPL
Label
Jun 1977 SUPPL
Mfg
May 1977 SUPPL
Mfg
Mar 1977 SUPPL
Mfg
Feb 1977 SUPPL
Mfg
Sep 1976 SUPPL
Label
Aug 1976 SUPPL
Mfg
Sep 1974 SUPPL
Mfg
Jan 1974 ORIGINAL
New Drug
What MOBAN Treats
2 FDA approvalsOriginally approved for its first indication in 1974 . Covers 2 distinct patient populations.
- Other (2)
Other
(2 approvals)- • Approved indication (Jan 1974)
- • Approved indication (Dec 1979)
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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.
MOBAN FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.