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Last Updated: March 28, 2024

Butabarbital sodium - Generic Drug Details


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What are the generic drug 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, 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 four drug master file entries for butabarbital sodium.

Recent Clinical Trials for butabarbital sodium

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

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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
Halsey SARISOL NO. 2 butabarbital sodium TABLET;ORAL 084719-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Speciality Lp BUTISOL SODIUM butabarbital sodium TABLET;ORAL 000793-004 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Speciality Lp BUTISOL SODIUM butabarbital sodium TABLET;ORAL 000793-005 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva BUTABARBITAL SODIUM butabarbital sodium TABLET;ORAL 088631-001 May 1, 1985 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Whiteworth Town Plsn BUTABARBITAL SODIUM butabarbital sodium TABLET;ORAL 083325-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Wockhardt BUTABARBITAL SODIUM butabarbital sodium ELIXIR;ORAL 085383-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Watson Labs BUTABARBITAL SODIUM butabarbital sodium TABLET;ORAL 085764-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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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