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Generated: November 21, 2018

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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. It is available from one supplier. 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. One supplier is listed for this compound. Additional details are available on the butabarbital sodium profile page.
Summary for 000793
Applicant:Mylan Speciality Lp
Ingredient:butabarbital sodium
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 000793
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BUTISOL SODIUM butabarbital sodium TABLET;ORAL 000793 NDA Meda Pharmaceuticals 0037-0113 0037-0113-60 100 TABLET in 1 BOTTLE (0037-0113-60)

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength15MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength50MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 004

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

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