APPLICATION
ANDA040779
TYPE
ANDA
ORIGINAL APPROVAL
2008-05-29
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
Approval history
2026-06-18REMS · Supplement 41AP
2025-12-22Labeling · Supplement 40 · standardAP
2025-03-05Labeling · Supplement 38 · standardAP
2024-10-31REMS · Supplement 39AP
2023-12-15Labeling · Supplement 37 · standardAP
2023-12-15Labeling · Supplement 35 · standardAP
2023-11-21Labeling · Supplement 28 · standardAP
2021-03-04Labeling · Supplement 24 · standardAP
2019-10-08Labeling · Supplement 21 · standardAP
2018-09-21Labeling · Supplement 18 · standardAP
2018-09-18REMS · Supplement 19AP
2017-08-29Labeling · Supplement 17 · standardAP
2016-12-16Labeling · Supplement 15 · standardAP
2016-12-16Labeling · Supplement 14 · standardAP
2016-03-23Labeling · Supplement 5AP
2013-10-18Labeling · Supplement 12 · standardAP
2013-05-10Labeling · Supplement 11 · standardAP
2011-06-23Labeling · Supplement 8AP
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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