APPLICATION
ANDA085418
TYPE
ANDA
ORIGINAL APPROVAL
1977-08-15
LATEST ACTION
1991-03-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
SODIUM BUTABARBITALDiscontinued
BUTABARBITAL SODIUM 15MG · TABLET · ORAL
Approval history
1991-03-28Manufacturing (CMC) · Supplement 9AP
1989-08-04Labeling · Supplement 8AP
1988-03-16Labeling · Supplement 7AP
1982-11-08Manufacturing (CMC) · Supplement 4AP
1977-08-15OriginalAP
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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