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FDA ANDA · ANDA085794

ACETAMINOPHEN AND CODEINE PHOSPHATE

Sponsor: MUTUAL PHARM

APPLICATION
ANDA085794
TYPE
ANDA
ORIGINAL APPROVAL
1978-01-20
LATEST ACTION
1998-12-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

1998-12-01Manufacturing (CMC) · Supplement 47AP
1996-09-24Labeling · Supplement 46AP
1994-12-23Manufacturing (CMC) · Supplement 45AP
1992-04-03Manufacturing (CMC) · Supplement 44AP
1992-04-03Manufacturing (CMC) · Supplement 42AP
1991-11-05Labeling · Supplement 41AP
1990-05-24Labeling · Supplement 38AP
1990-05-24Manufacturing (CMC) · Supplement 36AP
1990-05-24Labeling · Supplement 34AP
1990-05-24Manufacturing (CMC) · Supplement 37AP
1989-12-22Manufacturing (CMC) · Supplement 40AP
1989-06-09Labeling · Supplement 39AP
1988-08-18Labeling · Supplement 35AP
1988-05-06Manufacturing (CMC) · Supplement 26AP
1988-05-06Manufacturing (CMC) · Supplement 32AP
1988-02-17Manufacturing (CMC) · Supplement 29AP
1987-03-31Manufacturing (CMC) · Supplement 28AP
1985-07-26Manufacturing (CMC) · Supplement 22AP
1985-07-26Manufacturing (CMC) · Supplement 21AP
1985-03-01Manufacturing (CMC) · Supplement 18AP
1985-03-01Manufacturing (CMC) · Supplement 19AP
1985-03-01Manufacturing (CMC) · Supplement 17AP
1985-03-01Manufacturing (CMC) · Supplement 13AP
1978-01-20OriginalAP
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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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