APPLICATION
ANDA086710
TYPE
ANDA
ORIGINAL APPROVAL
1979-07-25
LATEST ACTION
2001-11-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
BUTALBITAL, ASPIRIN AND CAFFEINEDiscontinued
ASPIRIN 325MG, BUTALBITAL 50MG, CAFFEINE 40MG · TABLET · ORAL
Approval history
2001-11-02Manufacturing (CMC) · Supplement 46AP
1999-10-12Labeling · Supplement 45AP
1998-11-23Manufacturing (CMC) · Supplement 44AP
1998-03-09Labeling · Supplement 43AP
1997-05-09Manufacturing (CMC) · Supplement 42AP
1996-01-18Manufacturing (CMC) · Supplement 41AP
1991-11-25Labeling · Supplement 40AP
1990-11-05Manufacturing (CMC) · Supplement 35AP
1990-11-05Manufacturing (CMC) · Supplement 33AP
1990-11-05Manufacturing (CMC) · Supplement 34AP
1989-10-04Labeling · Supplement 39AP
1989-08-04Labeling · Supplement 37AP
1989-08-04Labeling · Supplement 38AP
1985-08-13Manufacturing (CMC) · Supplement 29AP
1985-08-13Manufacturing (CMC) · Supplement 27AP
1985-08-13Manufacturing (CMC) · Supplement 28AP
1985-08-13Manufacturing (CMC) · Supplement 30AP
1985-03-15Manufacturing (CMC) · Supplement 26AP
1983-10-25Manufacturing (CMC) · Supplement 24AP
1983-10-25Manufacturing (CMC) · Supplement 20AP
1983-07-06Manufacturing (CMC) · Supplement 21AP
1979-07-25OriginalAP
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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