Data updated: May 26, 2026
MYAMBUTOL (ethambutol hydrochloride)
Infectious Disease
Approved 1967-11-06
1
Indication
--
Phase 3 Trials
1
Priority Reviews
58
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1967-11-06
- Routes
- ORAL
- Dosage Forms
- TABLET
MYAMBUTOL Approval History
1968
1969
1970
1971
1972
1973
1974
1975
1976
1977
1978
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1981
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2026
Original
New Indication
New Form
Label Update
136 FDA actions from 1967 to 2013
May 1998 SUPPL Priority
Mfg
May 1998 SUPPL Priority
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Jun 1995 SUPPL Priority
Mfg
Nov 1987 SUPPL Priority
Mfg
Nov 1987 SUPPL Priority
Mfg
Jun 1987 SUPPL
Label
May 1987 SUPPL Priority
Mfg
Jan 1986 SUPPL Priority
Mfg
Sep 1985 SUPPL Priority
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Feb 1982 SUPPL Priority
Mfg
Nov 1981 SUPPL Priority
Mfg
Aug 1981 SUPPL Priority
Mfg
Jul 1981 SUPPL Priority
Mfg
Jan 1981 SUPPL Priority
Mfg
Apr 1979 SUPPL Priority
Mfg
Dec 1978 SUPPL
Label
Jun 1978 SUPPL Priority
Mfg
Jun 1978 SUPPL Priority
Mfg
May 1978 SUPPL Priority
Mfg
Apr 1978 SUPPL Priority
Mfg
Jul 1977 SUPPL Priority
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May 1977 SUPPL Priority
Mfg
Jun 1976 SUPPL Priority
Mfg
Apr 1976 SUPPL Priority
Mfg
Feb 1975 SUPPL Priority
Mfg
Nov 1967 ORIGINAL Priority
New Drug
What MYAMBUTOL Treats
1 FDA approvalsOriginally approved for its first indication in 1967 .
- Other (1)
Other
(1 approval)- • Approved indication (Nov 1967) 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.
MYAMBUTOL FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.