APPLICATION
ANDA089231
TYPE
ANDA
ORIGINAL APPROVAL
1986-03-03
LATEST ACTION
2002-08-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ACETAMINOPHEN AND CODEINE PHOSPHATEDiscontinued
ACETAMINOPHEN 650MG, CODEINE PHOSPHATE 30MG · TABLET · ORAL
Approval history
2002-08-13Manufacturing (CMC) · Supplement 27AP
1998-10-21Manufacturing (CMC) · Supplement 26AP
1998-07-31Manufacturing (CMC) · Supplement 25AP
1996-05-08Manufacturing (CMC) · Supplement 23AP
1996-05-08Manufacturing (CMC) · Supplement 24AP
1996-05-08Manufacturing (CMC) · Supplement 22AP
1995-07-14Manufacturing (CMC) · Supplement 21AP
1995-05-30Labeling · Supplement 20AP
1995-02-08Manufacturing (CMC) · Supplement 19AP
1993-11-23Manufacturing (CMC) · Supplement 13AP
1991-10-16Manufacturing (CMC) · Supplement 5AP
1991-05-08Labeling · Supplement 18AP
1991-02-08Labeling · Supplement 9AP
1991-02-08Manufacturing (CMC) · Supplement 7AP
1991-02-08Manufacturing (CMC) · Supplement 8AP
1991-02-08Manufacturing (CMC) · Supplement 6AP
1991-02-08Manufacturing (CMC) · Supplement 4AP
1989-07-11Manufacturing (CMC) · Supplement 16AP
1988-10-21Manufacturing (CMC) · Supplement 15AP
1988-09-02Labeling · Supplement 10AP
1988-06-20Manufacturing (CMC) · Supplement 11AP
1988-06-20Manufacturing (CMC) · Supplement 12AP
1987-07-14Manufacturing (CMC) · Supplement 3AP
1987-07-14Manufacturing (CMC) · Supplement 2AP
1986-11-06Manufacturing (CMC) · Supplement 1AP
1986-03-03OriginalAP
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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