APPLICATION
ANDA040419
TYPE
ANDA
ORIGINAL APPROVAL
2001-05-31
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ACETAMINOPHEN AND CODEINE PHOSPHATEPrescription
ACETAMINOPHEN 300MG, CODEINE PHOSPHATE 30MG · TABLET · ORAL
ACETAMINOPHEN AND CODEINE PHOSPHATEPrescription
ACETAMINOPHEN 300MG, CODEINE PHOSPHATE 60MG · TABLET · ORAL
ACETAMINOPHEN AND CODEINE PHOSPHATEPrescription
ACETAMINOPHEN 300MG, CODEINE PHOSPHATE 15MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 41AP
2025-12-22Labeling · Supplement 40 · standardAP
2025-03-10Labeling · Supplement 37 · standardAP
2024-10-31REMS · Supplement 38AP
2023-12-15Labeling · Supplement 36 · standardAP
2023-12-15Labeling · Supplement 35 · standardAP
2021-03-04Labeling · Supplement 29 · standardAP
2019-10-07Labeling · Supplement 26 · standardAP
2018-09-20Labeling · Supplement 25 · standardAP
2018-09-18REMS · Supplement 24AP
2018-04-06Labeling · Supplement 23 · standardAP
2018-04-06Labeling · Supplement 21 · standardAP
2016-12-16Labeling · Supplement 19 · standardAP
2016-12-16Labeling · Supplement 17 · standardAP
2013-10-18Labeling · Supplement 16 · standardAP
2013-05-10Labeling · Supplement 14 · standardAP
2011-06-22Labeling · Supplement 12AP
2008-02-21Labeling · Supplement 11AP
2007-11-30Labeling · Supplement 10AP
2002-12-13Labeling · Supplement 4AP
2002-12-13Manufacturing (CMC) · Supplement 2AP
2002-12-13Manufacturing (CMC) · Supplement 3AP
2002-04-11Manufacturing (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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