APPLICATION
ANDA086231
TYPE
ANDA
ORIGINAL APPROVAL
1982-06-16
LATEST ACTION
1991-11-27
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
BUTALBITAL, ASPIRIN AND CAFFEINEDiscontinued
ASPIRIN 325MG, BUTALBITAL 50MG, CAFFEINE 40MG · CAPSULE · ORAL
Approval history
1991-11-27Labeling · Supplement 26AP
1991-02-15Labeling · Supplement 25AP
1988-07-18Labeling · Supplement 19AP
1988-06-13Labeling · Supplement 18AP
1988-03-08Labeling · Supplement 17AP
1982-06-16OriginalAP
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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