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FDA ANDA · ANDA085868
ACETAMINOPHEN AND CODEINE PHOSPHATE
Sponsor: SUN PHARM INDS LTD
APPLICATION
ANDA085868
TYPE
ANDA
ORIGINAL APPROVAL
1978-11-06
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ACETAMINOPHEN AND CODEINE PHOSPHATEDiscontinued
ACETAMINOPHEN 300MG, CODEINE PHOSPHATE 30MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 71AP
2025-12-22Labeling · Supplement 68 · standardAP
2025-12-22Labeling · Supplement 70 · standardAP
2024-10-31REMS · Supplement 69AP
2023-12-15Labeling · Supplement 67 · standardAP
2021-03-04Labeling · Supplement 66 · standardAP
2019-10-07Labeling · Supplement 65 · standardAP
2018-09-21Labeling · Supplement 64 · standardAP
2018-09-18REMS · Supplement 63AP
2017-08-29Labeling · Supplement 61 · standardAP
2017-08-29Labeling · Supplement 62 · standardAP
2016-12-16Labeling · Supplement 60 · standardAP
2016-12-16Labeling · Supplement 59 · standardAP
2014-03-20Labeling · Supplement 58 · standardAP
2013-05-14Labeling · Supplement 57 · standardAP
2011-06-23Labeling · Supplement 56AP
2008-06-05Labeling · Supplement 55AP
2007-10-18Labeling · Supplement 54AP
2002-09-05Manufacturing (CMC) · Supplement 47AP
2002-09-05Manufacturing (CMC) · Supplement 45AP
2002-09-05Manufacturing (CMC) · Supplement 48AP
2002-09-05Manufacturing (CMC) · Supplement 44AP
2000-01-28Manufacturing (CMC) · Supplement 43AP
1995-01-09Manufacturing (CMC) · Supplement 39AP
1995-01-09Labeling · Supplement 41AP
1995-01-09Manufacturing (CMC) · Supplement 42AP
1995-01-09Manufacturing (CMC) · Supplement 40AP
1989-07-12Labeling · Supplement 38AP
1988-08-25Labeling · Supplement 37AP
1987-02-06Manufacturing (CMC) · Supplement 31AP
1987-02-06Manufacturing (CMC) · Supplement 30AP
1987-02-06Manufacturing (CMC) · Supplement 22AP
1985-10-15Manufacturing (CMC) · Supplement 28AP
1982-08-13Manufacturing (CMC) · Supplement 25AP
1982-07-14Manufacturing (CMC) · Supplement 21AP
1982-07-14Manufacturing (CMC) · Supplement 20AP
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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