APPLICATION
ANDA085934
TYPE
ANDA
ORIGINAL APPROVAL
1994-09-16
LATEST ACTION
1994-09-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
BUTABARBITAL SODIUMDiscontinued
BUTABARBITAL SODIUM 30MG · TABLET · ORAL
Approval history
1994-09-16OriginalAP
1985-05-28Manufacturing (CMC) · Supplement 9AP
1983-08-11Manufacturing (CMC) · Supplement 11AP
1982-11-12Manufacturing (CMC) · Supplement 10AP
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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