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FDA ANDA · ANDA202800
ACETAMINOPHEN AND CODEINE PHOSPHATE
Sponsor: AUROLIFE PHARMA LLC
APPLICATION
ANDA202800
TYPE
ANDA
ORIGINAL APPROVAL
2013-04-15
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ACETAMINOPHEN AND CODEINE PHOSPHATEPrescription
ACETAMINOPHEN 300MG, CODEINE PHOSPHATE 60MG · TABLET · ORAL
ACETAMINOPHEN AND CODEINE PHOSPHATEPrescription
ACETAMINOPHEN 300MG, CODEINE PHOSPHATE 15MG · TABLET · ORAL
ACETAMINOPHEN AND CODEINE PHOSPHATEPrescription
ACETAMINOPHEN 300MG, CODEINE PHOSPHATE 30MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 22AP
2025-12-22Labeling · Supplement 20 · standardAP
2024-10-31REMS · Supplement 18AP
2024-03-06Labeling · Supplement 17 · standardAP
2024-03-05Labeling · Supplement 15 · standardAP
2024-03-05Labeling · Supplement 16 · standardAP
2024-03-05Labeling · Supplement 14 · standardAP
2021-03-04Labeling · Supplement 13 · standardAP
2019-10-07Labeling · Supplement 12 · standardAP
2018-09-20Labeling · Supplement 11 · standardAP
2018-09-18REMS · Supplement 9AP
2017-09-29Labeling · Supplement 7 · standardAP
2016-12-16Labeling · Supplement 4 · standardAP
2016-12-16Labeling · Supplement 5 · standardAP
2013-10-18Labeling · Supplement 3 · standardAP
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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