APPLICATION
ANDA086398
TYPE
ANDA
ORIGINAL APPROVAL
1980-07-30
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
BUTALBITAL, ASPIRIN AND CAFFEINEDiscontinued
ASPIRIN 325MG, BUTALBITAL 50MG, CAFFEINE 40MG · TABLET · ORAL
Approval history
2024-11-21Labeling · Supplement 51 · standardAP
2000-01-13Manufacturing (CMC) · Supplement 46AP
1996-10-28Manufacturing (CMC) · Supplement 45AP
1992-01-09Labeling · Supplement 44AP
1990-11-09Manufacturing (CMC) · Supplement 43AP
1990-01-01Labeling · Supplement 52AP
1990-01-01Labeling · Supplement 42AP
1988-01-15Manufacturing (CMC) · Supplement 38AP
1987-02-06Manufacturing (CMC) · Supplement 34AP
1987-01-23Manufacturing (CMC) · Supplement 37AP
1984-12-19Manufacturing (CMC) · Supplement 32AP
1984-12-19Manufacturing (CMC) · Supplement 30AP
1984-08-06Manufacturing (CMC) · Supplement 29AP
1984-05-24Manufacturing (CMC) · Supplement 28AP
1984-04-27Manufacturing (CMC) · Supplement 27AP
1984-04-06Manufacturing (CMC) · Supplement 25AP
1984-04-06Manufacturing (CMC) · Supplement 23AP
1984-04-06Manufacturing (CMC) · Supplement 26AP
1983-07-01Manufacturing (CMC) · Supplement 21AP
1983-02-14Manufacturing (CMC) · Supplement 20AP
1982-12-17Manufacturing (CMC) · Supplement 17AP
1982-12-17Manufacturing (CMC) · Supplement 18AP
1982-12-17Manufacturing (CMC) · Supplement 19AP
1980-07-30OriginalAP
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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