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Last Updated: August 6, 2020

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BUTABARBITAL SODIUM - Generic Drug Details

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What are the generic sources for butabarbital sodium and what is the scope of freedom to operate?

Butabarbital sodium is the generic ingredient in ten branded drugs marketed by Medpointe Pharm Hlc, Alpharma Us Pharms, Wockhardt, Lannett, Meda Pharms, Halsey, Bundy, Sandoz, Solvay, Teva, Watson Labs, Whiteworth Town Plsn, Mylan Speciality Lp, Hikma Pharms, Ivax Sub Teva Pharms, and Marshall Pharma, and is included in thirty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for butabarbital sodium.

Summary for BUTABARBITAL SODIUM
Recent Clinical Trials for BUTABARBITAL SODIUM

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4
Federal University of São PauloPhase 4

See all BUTABARBITAL SODIUM clinical trials

US Patents and Regulatory Information for BUTABARBITAL SODIUM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bundy BUTABARBITAL butabarbital sodium TABLET;ORAL 085550-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Solvay BUTABARBITAL SODIUM butabarbital sodium TABLET;ORAL 083896-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Solvay BUTABARBITAL SODIUM butabarbital sodium TABLET;ORAL 083898-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Sandoz BUTABARBITAL SODIUM butabarbital sodium TABLET;ORAL 084292-003 Feb 9, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Hikma Pharms SODIUM BUTABARBITAL butabarbital sodium TABLET;ORAL 085418-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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