Viewing data from:

Not in the current Orange Book — This application is not listed in FDA's current Orange Book data files (no listed patents or exclusivities). Product and approval data shown are from FDA's Drugs@FDA database.

SODIUM BUTABARBITAL

ANDANot in Orange Book

BUTABARBITAL SODIUM | A085432 | HIKMA

API Supply Chain2 active DMFs4 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

CHATTEM CHEMICALS INCBUTABARBITAL SODIUM

DMF 144381999

CURIA WISCONSIN INCBUTABARBITAL SODIUM, USP

DMF 146361999

GANES CHEMICALS INC PENNSVILLE DIVInactiveBUTABARBITAL

DMF 10481967

GRINDSTED PRODUCTSInactiveBUTABARBITAL SODIUM

DMF 43661981

DANISCO INGREDIENTSInactiveBUTABARBITAL

DMF 64901986

CHEMISCHE FABRIK BERG GMBHInactiveBUTABARBITAL SODIUM

DMF 147912000

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (1)

#001 — 30MG

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TABLET;ORAL | Approved: Dec. 20, 1977

No patent or exclusivity listings for this strength.