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FDA ANDA · ANDA087508
ACETAMINOPHEN AND CODEINE PHOSPHATE
Sponsor: GENUS LIFESCIENCES
APPLICATION
ANDA087508
TYPE
ANDA
ORIGINAL APPROVAL
1981-08-21
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
ACETAMINOPHEN AND CODEINE PHOSPHATEPrescription
ACETAMINOPHEN 120MG/5ML, CODEINE PHOSPHATE 12MG/5ML · SOLUTION · ORAL
Approval history
2026-06-18REMS · Supplement 62AP
2025-12-22Labeling · Supplement 60 · standardAP
2025-12-22Labeling · Supplement 57 · standardAP
2024-10-31REMS · Supplement 58AP
2023-12-15Labeling · Supplement 56 · standardAP
2021-03-04Labeling · Supplement 51 · standardAP
2019-10-07Labeling · Supplement 47 · standardAP
2018-09-21Labeling · Supplement 44 · standardAP
2018-09-18REMS · Supplement 43AP
2018-01-29Labeling · Supplement 41 · standardAP
2017-08-29Labeling · Supplement 39 · standardAP
2016-12-16Labeling · Supplement 37 · standardAP
2016-12-16Labeling · Supplement 36 · standardAP
2015-12-01Labeling · Supplement 35 · standardAP
2013-10-18Labeling · Supplement 34 · standardAP
2013-05-10Labeling · Supplement 33 · standardAP
2011-06-28Labeling · Supplement 32AP
2008-08-25Labeling · Supplement 31AP
2008-03-07Labeling · Supplement 30AP
1994-07-19Labeling · Supplement 24AP
1993-12-02Manufacturing (CMC) · Supplement 22AP
1993-08-17Labeling · Supplement 23AP
1991-12-18Manufacturing (CMC) · Supplement 17AP
1991-12-18Labeling · Supplement 21AP
1991-12-18Manufacturing (CMC) · Supplement 16AP
1991-08-08Labeling · Supplement 20AP
1991-05-09Labeling · Supplement 19AP
1989-12-28Labeling · Supplement 18AP
1988-09-07Labeling · Supplement 13AP
1988-06-09Manufacturing (CMC) · Supplement 12AP
1986-08-18Manufacturing (CMC) · Supplement 5AP
1986-08-18Manufacturing (CMC) · Supplement 6AP
1982-12-16Manufacturing (CMC) · Supplement 2AP
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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