APPLICATION
ANDA089450
TYPE
ANDA
ORIGINAL APPROVAL
1992-10-27
LATEST ACTION
2025-12-22
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
ACETAMINOPHEN AND CODEINE PHOSPHATEDiscontinued
ACETAMINOPHEN 120MG/5ML, CODEINE PHOSPHATE 12MG/5ML · SOLUTION · ORAL
Approval history
2025-12-22Labeling · Supplement 31 · standardAP
2025-12-05Labeling · Supplement 30 · standardAP
2023-12-15Labeling · Supplement 29 · standardAP
2023-12-15Labeling · Supplement 28 · standardAP
2021-03-05Labeling · Supplement 27 · standardAP
2019-10-07Labeling · Supplement 26 · standardAP
2018-09-21Labeling · Supplement 25 · standardAP
2018-09-18REMS · Supplement 24AP
2018-02-21Labeling · Supplement 23 · standardAP
2017-08-29Labeling · Supplement 21 · standardAP
2017-08-25Labeling · Supplement 22 · standardAP
2016-12-16Labeling · Supplement 19 · standardAP
2016-12-16Labeling · Supplement 20 · standardAP
2013-10-18Labeling · Supplement 17 · standardAP
2013-05-14Labeling · Supplement 16 · standardAP
2011-06-28Labeling · Supplement 15AP
2007-11-16Labeling · Supplement 13AP
2007-09-12Labeling · Supplement 12AP
2002-08-13Manufacturing (CMC) · Supplement 9AP
1998-07-31Manufacturing (CMC) · Supplement 8AP
1998-03-31Manufacturing (CMC) · Supplement 7AP
1997-04-08Manufacturing (CMC) · Supplement 4AP
1997-04-08Labeling · Supplement 5AP
1996-02-12Labeling · Supplement 2AP
1995-12-08Manufacturing (CMC) · Supplement 6AP
1995-09-01Manufacturing (CMC) · Supplement 1AP
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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