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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 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 NDA: 000793

Meda Pharms
butabarbital sodium

Suppliers and Packaging for NDA: 000793

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
butabarbital sodium
TABLET;ORAL 000793 NDA Meda Pharmaceuticals Inc. 0037-0113 0037-0113-60 100 TABLET in 1 BOTTLE (0037-0113-60)

Summary for product number 002

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

Summary for product number 003

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

Summary 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.