APPLICATION
ANDA087006
TYPE
ANDA
ORIGINAL APPROVAL
1981-07-22
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
ACETAMINOPHEN AND CODEINE PHOSPHATEDiscontinued
ACETAMINOPHEN 120MG/5ML, CODEINE PHOSPHATE 12MG/5ML · SOLUTION · ORAL
Approval history
2026-06-18REMS · Supplement 45AP
2025-12-22Labeling · Supplement 43 · standardAP
2025-12-22Labeling · Supplement 44 · standardAP
2024-10-31REMS · Supplement 42AP
2021-03-04Labeling · Supplement 39 · standardAP
2019-10-07Labeling · Supplement 36 · standardAP
2018-09-18REMS · Supplement 33AP
2018-09-18Labeling · Supplement 34 · standardAP
2018-02-07Labeling · Supplement 32 · standardAP
2017-08-29Labeling · Supplement 31 · standardAP
2016-12-16Labeling · Supplement 30 · standardAP
2014-03-20Labeling · Supplement 28 · standardAP
2013-07-30Labeling · Supplement 27 · standardAP
2011-06-23Labeling · Supplement 26AP
2007-12-12Labeling · Supplement 25AP
2007-09-21Labeling · Supplement 24AP
2005-05-17Labeling · Supplement 23AP
1998-02-09Labeling · Supplement 21AP
1993-12-20Labeling · Supplement 20AP
1992-03-03Labeling · Supplement 19AP
1991-09-03Labeling · Supplement 18AP
1989-09-15Labeling · Supplement 17AP
1988-04-27Manufacturing (CMC) · Supplement 14AP
1987-03-06Manufacturing (CMC) · Supplement 10AP
1987-03-06Manufacturing (CMC) · Supplement 9AP
1987-02-10Manufacturing (CMC) · Supplement 8AP
1984-05-24Manufacturing (CMC) · Supplement 5AP
1984-01-16Manufacturing (CMC) · Supplement 4AP
1983-09-09Manufacturing (CMC) · Supplement 3AP
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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