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FDA ANDA · ANDA087653

ACETAMINOPHEN AND CODEINE PHOSPHATE

Sponsor: MUTUAL PHARM

APPLICATION
ANDA087653
TYPE
ANDA
ORIGINAL APPROVAL
1982-04-13
LATEST ACTION
1998-12-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ACETAMINOPHEN AND CODEINE PHOSPHATEDiscontinued
ACETAMINOPHEN 300MG, CODEINE PHOSPHATE 60MG · TABLET · ORAL

Approval history

1998-12-01Manufacturing (CMC) · Supplement 33AP
1996-09-24Labeling · Supplement 32AP
1994-12-23Manufacturing (CMC) · Supplement 31AP
1992-04-03Manufacturing (CMC) · Supplement 28AP
1992-04-03Manufacturing (CMC) · Supplement 30AP
1991-11-27Labeling · Supplement 27AP
1990-05-31Labeling · Supplement 26AP
1989-01-17Labeling · Supplement 25AP
1988-04-22Manufacturing (CMC) · Supplement 23AP
1987-10-19Manufacturing (CMC) · Supplement 22AP
1987-10-19Manufacturing (CMC) · Supplement 20AP
1987-10-19Manufacturing (CMC) · Supplement 19AP
1987-10-19Manufacturing (CMC) · Supplement 21AP
1987-04-06Manufacturing (CMC) · Supplement 17AP
1987-04-01Manufacturing (CMC) · Supplement 16AP
1986-08-19Manufacturing (CMC) · Supplement 9AP
1986-08-19Manufacturing (CMC) · Supplement 11AP
1986-08-19Manufacturing (CMC) · Supplement 10AP
1985-08-01Manufacturing (CMC) · Supplement 2AP
1982-04-13OriginalAP
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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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