Assyro AI

FDA Orange Book · active-ingredient family

Butabarbital sodium

Butabarbital sodium is approved as 1 brand and 31 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:BUTISOL SODIUM · NDA 000793

1

Brand (NDA)

31

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, elixir, tablet

ProductApplicantApplicationTEApproved
BUTISOL SODIUMRLD×4PHARMOBEDIENTNDA 000793—Approved Prior to Jan 1, 1982

Generic (ANDA) products (31)

ProductApplicantApplicationTEApproved
BUTABARBITAL SODIUMTEVAANDA 088632—May 18, 1985
BUTABARBITAL SODIUMTEVAANDA 088631—May 01, 1985
BUTABARBITAL SODIUMSANDOZANDA 084292—Feb 09, 1982
BUTICAPS×4MEDPOINTE PHARM HLCANDA 085381—Approved Prior to Jan 1, 1982
BUTABARBALPHARMA US PHARMSANDA 085873—Approved Prior to Jan 1, 1982
BUTABARBITAL SODIUMWOCKHARDTANDA 085383—Approved Prior to Jan 1, 1982
BUTALANLANNETTANDA 085880—Approved Prior to Jan 1, 1982
BUTISOL SODIUMMEDA PHARMSANDA 085380—Approved Prior to Jan 1, 1982
SARISOLHALSEYANDA 084723—Approved Prior to Jan 1, 1982
BUTABARBITALBUNDYANDA 085550—Approved Prior to Jan 1, 1982
BUTABARBITAL SODIUMRLDSANDOZANDA 085938—Approved Prior to Jan 1, 1982
BUTABARBITAL SODIUMSANDOZANDA 084272—Approved Prior to Jan 1, 1982
BUTABARBITAL SODIUMSANDOZANDA 085934—Approved Prior to Jan 1, 1982
BUTABARBITAL SODIUMSOLVAYANDA 083606—Approved Prior to Jan 1, 1982
BUTABARBITAL SODIUMSOLVAYANDA 083898—Approved Prior to Jan 1, 1982
BUTABARBITAL SODIUMSOLVAYANDA 083897—Approved Prior to Jan 1, 1982
BUTABARBITAL SODIUMSOLVAYANDA 083896—Approved Prior to Jan 1, 1982
BUTABARBITAL SODIUMWATSON LABSANDA 085764—Approved Prior to Jan 1, 1982
BUTABARBITAL SODIUMWATSON LABSANDA 085772—Approved Prior to Jan 1, 1982
BUTABARBITAL SODIUMWHITEWORTH TOWN PLSNANDA 083325—Approved Prior to Jan 1, 1982
BUTABARBITAL SODIUMWHITEWORTH TOWN PLSNANDA 083337—Approved Prior to Jan 1, 1982
SARISOL NO. 1×2HALSEYANDA 084719—Approved Prior to Jan 1, 1982
SODIUM BUTABARBITALHIKMAANDA 085418—Approved Prior to Jan 1, 1982
SODIUM BUTABARBITALHIKMAANDA 085432—Approved Prior to Jan 1, 1982
SODIUM BUTABARBITALIVAX SUB TEVA PHARMSANDA 083484—Approved Prior to Jan 1, 1982
SODIUM BUTABARBITALIVAX SUB TEVA PHARMSANDA 084040—Approved Prior to Jan 1, 1982
SODIUM BUTABARBITALLANNETTANDA 085849—Approved Prior to Jan 1, 1982
SODIUM BUTABARBITALLANNETTANDA 085866—Approved Prior to Jan 1, 1982
SODIUM BUTABARBITALLANNETTANDA 085881—Approved Prior to Jan 1, 1982
SODIUM BUTABARBITALMARSHALL PHARMAANDA 083524—Approved Prior to Jan 1, 1982
SODIUM BUTABARBITALMARSHALL PHARMAANDA 083858—Approved Prior to Jan 1, 1982

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Butabarbital sodium — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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