Data updated: Nov 8, 2026
NEMBUTAL SODIUM (pentobarbital sodium) · EPIC PHARMA LLC
CNS
Approved 1973-09-19
FDA label not available. This product's label is not in FDA's label database (openFDA, DailyMed). Search DailyMed → · Drugs@FDA approval documents →
4
Indications
--
Phase 3 Trials
53
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1973-09-19
- Routes
- ORAL, INJECTION
- Dosage Forms
- CAPSULE, INJECTABLE
NEMBUTAL SODIUM Approval History
1974
1975
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Original
New Indication
New Form
Label Update
23 FDA actions from 1973 to 2019
Feb 2019 SUPPL
Label · Labeling
Apr 2017 SUPPL
Label · Labeling
May 2007 SUPPL
Label · Labeling
Sep 2003 SUPPL
Label
May 2002 SUPPL
Mfg
Apr 1998 SUPPL
Mfg
Feb 1993 SUPPL
Mfg
Dec 1992 SUPPL
Mfg
May 1992 SUPPL
Label
Apr 1986 SUPPL
Mfg
Mar 1986 SUPPL
Mfg
Jun 1985 SUPPL
Mfg
May 1982 SUPPL
Mfg
Feb 1975 ORIGINAL
Update
Feb 1975 ORIGINAL
Update
Jan 1975 ORIGINAL
Update
Sep 1973 ORIGINAL
Update
What NEMBUTAL SODIUM Treats
4 FDA approvalsOriginally approved for its first indication in 1973 . Covers 4 distinct patient populations.
- Other (4)
Other
(4 approvals)- • Approved indication (Sep 1973)
- • Approved indication (Jan 1975)
- • Approved indication (Feb 1975)
- • Approved indication (Feb 1975)
🔬
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.
NEMBUTAL SODIUM FDA Label Details
FDA label not available. This product's label is not in FDA's label database (openFDA, DailyMed). Search DailyMed → · Drugs@FDA approval documents →
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.