APPLICATION
ANDA085432
TYPE
ANDA
ORIGINAL APPROVAL
1977-12-20
LATEST ACTION
1991-01-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
SODIUM BUTABARBITALDiscontinued
BUTABARBITAL SODIUM 30MG · TABLET · ORAL
Approval history
1991-01-28Manufacturing (CMC) · Supplement 8AP
1989-06-13Labeling · Supplement 7AP
1988-03-18Labeling · Supplement 6AP
1982-11-10Manufacturing (CMC) · Supplement 3AP
1977-12-20OriginalAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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