Details for New Drug Application (NDA): 000793
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NDA 000793 describes BUTISOL SODIUM, which is a drug marketed by Meda Pharms and Mylan Speciality Lp and is included in two NDAs. Additional details are available on the BUTISOL SODIUM profile page.
The generic ingredient in BUTISOL SODIUM is butabarbital sodium. There are nine drug master file entries for this compound. Additional details are available on the butabarbital sodium profile page.
The generic ingredient in BUTISOL SODIUM is butabarbital sodium. There are nine drug master file entries for this compound. Additional details are available on the butabarbital sodium profile page.
Summary for 000793
| Tradename: | BUTISOL SODIUM |
| Applicant: | Mylan Speciality Lp |
| Ingredient: | butabarbital sodium |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 004
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 30MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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