NEMBUTAL SODIUM (pentobarbital sodium) · EPIC PHARMA LLC
Parenteral Sedatives. Hypnotics, for the short-term treatment of insomnia, since they appear to lose their effectiveness for sleep induction and sleep maintenance after 2 weeks (See " Clinical Pharmacology " section). Preanesthetics. Anticonvulsant, in anesthetic doses, in the emergency control of certain acute convulsive episodes, e.g., those associated with status epilepticus, cholera, eclampsia, meningitis, tetanus, and toxic reactions to strychnine or local anesthetics.
Details
- Status
- Discontinued
- First Approved
- 1973-09-19
- Routes
- ORAL, INJECTION
- Dosage Forms
- CAPSULE, INJECTABLE
NEMBUTAL SODIUM Approval History
What NEMBUTAL SODIUM Treats
7 indicationsNEMBUTAL SODIUM is approved for 7 conditions since its original approval in 1973. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Insomnia
- Convulsions
- Status Epilepticus
- Cholera
- Eclampsia
- Meningitis
- Tetanus
NEMBUTAL SODIUM Competitive Set
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Indication competitors
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Active Pipeline
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Key Completed Trials
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Trial Timeline
Full development history with FDA approval milestones
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
Indications & Usage
Parenteral Sedatives. Hypnotics, for the short-term treatment of insomnia, since they appear to lose their effectiveness for sleep induction and sleep maintenance after 2 weeks (See " Clinical Pharmacology " section). Preanesthetics. Anticonvulsant, in anesthetic doses, in the emergency control of certain acute convulsive episodes, e.g., those associated with status epilepticus, cholera, eclampsia, meningitis, tetanus, and toxic reactions to strychnine or local anesthetics.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.