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FDA ANDA · ANDA087083
ACETAMINOPHEN AND CODEINE PHOSPHATE
Sponsor: SUN PHARM INDS LTD
APPLICATION
ANDA087083
TYPE
ANDA
ORIGINAL APPROVAL
1980-01-23
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
Approval history
2026-06-18REMS · Supplement 59AP
2025-12-22Labeling · Supplement 58 · standardAP
2025-12-22Labeling · Supplement 56 · standardAP
2024-10-31REMS · Supplement 57AP
2023-12-15Labeling · Supplement 54 · standardAP
2021-03-04Labeling · Supplement 53 · standardAP
2019-10-07Labeling · Supplement 52 · standardAP
2018-09-21Labeling · Supplement 51 · standardAP
2018-09-18REMS · Supplement 50AP
2017-08-29Labeling · Supplement 49 · standardAP
2017-08-29Labeling · Supplement 48 · standardAP
2016-12-16Labeling · Supplement 47 · standardAP
2016-12-16Labeling · Supplement 46 · standardAP
2014-03-20Labeling · Supplement 45 · standardAP
2013-05-14Labeling · Supplement 44 · standardAP
2011-06-23Labeling · Supplement 43AP
2008-06-05Labeling · Supplement 42AP
2007-10-18Labeling · Supplement 41AP
2002-09-03Manufacturing (CMC) · Supplement 35AP
2002-09-03Manufacturing (CMC) · Supplement 31AP
2002-09-03Manufacturing (CMC) · Supplement 34AP
2002-09-03Manufacturing (CMC) · Supplement 32AP
2000-01-28Manufacturing (CMC) · Supplement 30AP
1995-01-09Manufacturing (CMC) · Supplement 27AP
1995-01-09Labeling · Supplement 28AP
1995-01-09Manufacturing (CMC) · Supplement 26AP
1995-01-05Manufacturing (CMC) · Supplement 29AP
1989-06-29Labeling · Supplement 25AP
1988-08-25Labeling · Supplement 24AP
1987-02-06Manufacturing (CMC) · Supplement 16AP
1987-02-06Manufacturing (CMC) · Supplement 19AP
1987-02-06Manufacturing (CMC) · Supplement 17AP
1987-02-06Manufacturing (CMC) · Supplement 18AP
1986-02-21Manufacturing (CMC) · Supplement 13AP
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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