FDA ANDA · ANDA089238

ACETAMINOPHEN AND CODEINE PHOSPHATE

Sponsor: MIKART

APPLICATION

ANDA089238

TYPE

ANDA

ORIGINAL APPROVAL

1986-02-25

LATEST ACTION

2002-08-13

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Discontinued

Products

ACETAMINOPHEN AND CODEINE PHOSPHATEDiscontinued

ACETAMINOPHEN 300MG, CODEINE PHOSPHATE 30MG · TABLET · ORAL

2002-08-13Manufacturing (CMC) · Supplement 14AP

1998-07-31Manufacturing (CMC) · Supplement 13AP

1995-06-05Labeling · Supplement 12AP

1993-07-20Manufacturing (CMC) · Supplement 10AP

1991-09-16Labeling · Supplement 3AP

1988-10-21Manufacturing (CMC) · Supplement 9AP

1988-06-20Manufacturing (CMC) · Supplement 5AP

1988-06-20Manufacturing (CMC) · Supplement 6AP

1988-01-18Manufacturing (CMC) · Supplement 4AP

1987-06-04Manufacturing (CMC) · Supplement 2AP

1986-11-06Manufacturing (CMC) · Supplement 1AP

1986-02-25OriginalAP

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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