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Last Updated: June 22, 2021

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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.
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:DISCNDosage:TABLET;ORALStrength15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 004

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength30MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

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