FDA
Butisol Sodium
The FDA lists this product in 5 strengths and forms.
Composition
- Active ingredients
- BUTABARBITAL SODIUM 30MG/5ML
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- BUTABARBITAL SODIUM 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletNDA000793-005 · Discontinued
- BUTABARBITAL SODIUM 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletNDA000793-003 · Discontinued
- BUTABARBITAL SODIUM 30MG · TabletNDA000793-004 · Discontinued
- BUTABARBITAL SODIUM 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TabletNDA000793-002 · Discontinued
- BUTABARBITAL SODIUM 30MG/5ML · ElixirThis page
Official product information
Drugs@FDA lists the approved labels, letters and reviews for application ANDA085380.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
At a glance
- Brand name
- Butisol Sodium
- Active substance
- butabarbital sodium
- Route
- Oral
- Dosage form
- Elixir
- Applicant
- Meda Pharms
- Status
- Discontinued
- FDA approval
- 10 Apr 1978
- Application
- ANDA085380-001