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FDA ANDA · ANDA040223

ACETAMINOPHEN AND CODEINE PHOSPHATE

Sponsor: DURAMED PHARMS BARR

APPLICATION
ANDA040223
TYPE
ANDA
ORIGINAL APPROVAL
1997-11-18
LATEST ACTION
2013-10-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ACETAMINOPHEN AND CODEINE PHOSPHATEDiscontinued
ACETAMINOPHEN 300MG, CODEINE PHOSPHATE 30MG · TABLET · ORAL
ACETAMINOPHEN AND CODEINE PHOSPHATEDiscontinued
ACETAMINOPHEN 300MG, CODEINE PHOSPHATE 60MG · TABLET · ORAL
ACETAMINOPHEN AND CODEINE PHOSPHATEDiscontinued
ACETAMINOPHEN 300MG, CODEINE PHOSPHATE 15MG · TABLET · ORAL

Approval history

2013-10-21Labeling · Supplement 26 · standardAP
2013-10-21Labeling · Supplement 27 · standard — Other ↗AP
2008-02-14Labeling · Supplement 23AP
2007-10-25Labeling · Supplement 22AP
2002-12-09Manufacturing (CMC) · Supplement 13AP
2002-12-09Manufacturing (CMC) · Supplement 14AP
2002-12-09Manufacturing (CMC) · Supplement 12AP
2002-04-09Manufacturing (CMC) · Supplement 9AP
2002-04-09Manufacturing (CMC) · Supplement 11AP
2002-04-09Manufacturing (CMC) · Supplement 8AP
2002-04-09Manufacturing (CMC) · Supplement 10AP
2000-06-05Manufacturing (CMC) · Supplement 7AP
2000-06-05Labeling · Supplement 5AP
2000-06-05Manufacturing (CMC) · Supplement 3AP
2000-06-05Manufacturing (CMC) · Supplement 6AP
2000-06-05Manufacturing (CMC) · Supplement 4AP
2000-06-05Manufacturing (CMC) · Supplement 2AP
1999-05-20Manufacturing (CMC) · Supplement 1AP
1997-11-18OriginalAP
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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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