APPLICATION
ANDA088944
TYPE
ANDA
ORIGINAL APPROVAL
1985-10-17
LATEST ACTION
1997-01-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
SEDAPAPDiscontinued
ACETAMINOPHEN 650MG, BUTALBITAL 50MG · TABLET · ORAL
Approval history
1997-01-17Manufacturing (CMC) · Supplement 10AP
1994-10-04Labeling · Supplement 9AP
1993-10-19Labeling · Supplement 8AP
1992-06-30Labeling · Supplement 7AP
1992-03-11Labeling · Supplement 6AP
1991-01-16Labeling · Supplement 5AP
1990-05-09Labeling · Supplement 4AP
1986-02-12Manufacturing (CMC) · Supplement 2AP
1986-02-12Manufacturing (CMC) · Supplement 1AP
1985-10-17OriginalAP
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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