Active substance
Butabarbital
- US FDA 33
- Safety 1
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| BUTISOL SODIUM | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 30MG; 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | tablet · oral | PHARMOBEDIENT | Discontinued | 5 Jun 1939 |
| SODIUM BUTABARBITAL | 15MG | tablet · oral | IVAX SUB TEVA PHARMS | Discontinued | 25 Sep 1973 |
| SODIUM BUTABARBITAL | 16.2MG | tablet · oral | MARSHALL PHARMA | Discontinued | 15 Jan 1974 |
| BUTABARBITAL SODIUM | 30MG | tablet · oral | WHITEWORTH TOWN PLSN | Discontinued | 28 Jan 1974 |
| BUTABARBITAL SODIUM | 15MG | tablet · oral | WHITEWORTH TOWN PLSN | Discontinued | 29 Jan 1974 |
| SODIUM BUTABARBITAL | 32.4MG | tablet · oral | MARSHALL PHARMA | Discontinued | 14 Mar 1974 |
| SODIUM BUTABARBITAL | 30MG | tablet · oral | IVAX SUB TEVA PHARMS | Discontinued | 31 May 1974 |
| BUTABARBITAL SODIUM | 16.2MG | tablet · oral | SOLVAY | Discontinued | 14 Jun 1974 |
| BUTABARBITAL SODIUM | 97.2MG | tablet · oral | SOLVAY | Discontinued | 21 Jun 1974 |
| BUTABARBITAL SODIUM | 48.6MG | tablet · oral | SOLVAY | Discontinued | 21 Jun 1974 |
| BUTABARBITAL SODIUM | 32.4MG | tablet · oral | SOLVAY | Discontinued | 21 Jun 1974 |
| SARISOL NO. 1 | 15MG | tablet · oral | HALSEY | Discontinued | 11 Feb 1976 |
| SARISOL NO. 2 | 30MG | tablet · oral | HALSEY | Discontinued | 11 Feb 1976 |
| SODIUM BUTABARBITAL | 15MG; 30MG | tablet · oral | HIKMA | Discontinued | 15 Aug 1977 |
| BUTABARBITAL SODIUM | 30MG | tablet · oral | WATSON LABS | Discontinued | 24 Aug 1977 |
| BUTABARBITAL SODIUM | 15MG | tablet · oral | WATSON LABS | Discontinued | 28 Oct 1977 |
| SODIUM BUTABARBITAL | 30MG | tablet · oral | HIKMA | Discontinued | 20 Dec 1977 |
| BUTISOL SODIUM | 30MG/5ML | elixir · oral | MEDA PHARMS | Discontinued | 10 Apr 1978 |
| BUTICAPS | 15MG; 30MG; 50MG; 100MG | capsule · oral | MEDPOINTE PHARM HLC | Discontinued | 11 Apr 1978 |
| BUTABARB | 30MG/5ML | elixir · oral | ALPHARMA US PHARMS | Discontinued | 17 May 1978 |
| BUTABARBITAL | 30MG | tablet · oral | BUNDY | Discontinued | 31 May 1978 |
| SODIUM BUTABARBITAL | 30MG | tablet · oral | LANNETT | Discontinued | 20 Jul 1978 |
| SODIUM BUTABARBITAL | 100MG | tablet · oral | LANNETT | Discontinued | 20 Jul 1978 |
| SODIUM BUTABARBITAL | 15MG | tablet · oral | LANNETT | Discontinued | 21 Aug 1978 |
| BUTALAN | 33.3MG/5ML | elixir · oral | LANNETT | Discontinued | 30 Aug 1978 |
8 more — full table
Safety signals and safety-related labeling changes
- US FDA 6 Feb 2019 BUTISOL SODIUM — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Patient Counseling Information / Patient Information / Medication Guide
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.