Data updated: May 26, 2026
SECTRAL (acebutolol hydrochloride)
Cardiovascular
Approved 1984-12-28
1
Indication
--
Phase 3 Trials
41
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1984-12-28
- Routes
- ORAL
- Dosage Forms
- CAPSULE
SECTRAL Approval History
1985
1986
1987
1988
1989
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1993
1994
1995
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2001
2002
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Original
New Indication
New Form
Label Update
40 FDA actions from 1984 to 2011
Jul 2001 SUPPL
Mfg · Manufacturing (CMC)
Aug 1999 SUPPL
Label
Nov 1997 SUPPL
Label
Aug 1989 SUPPL
Label
Mar 1989 SUPPL
Mfg
Dec 1988 SUPPL
Label
Oct 1988 SUPPL
Mfg
Dec 1987 SUPPL
Mfg
Nov 1987 SUPPL
Mfg
Aug 1987 SUPPL
Mfg
Jun 1987 SUPPL
Label
May 1987 SUPPL
Label
Jun 1986 SUPPL
Label
Jun 1986 SUPPL
Mfg
Aug 1985 SUPPL
Mfg
Feb 1985 SUPPL
Label
Dec 1984 ORIGINAL
New Drug
What SECTRAL Treats
1 FDA approvalsOriginally approved for its first indication in 1984 .
- Other (1)
Other
(1 approval)- • Approved indication (Dec 1984)
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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.
SECTRAL FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.