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FDA ANDA · ANDA089805
ACETAMINOPHEN AND CODEINE PHOSPHATE
Sponsor: STRIDES PHARMA INTL
APPLICATION
ANDA089805
TYPE
ANDA
ORIGINAL APPROVAL
1988-09-30
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 48AP
2025-12-22Labeling · Supplement 47 · standardAP
2025-03-28Labeling · Supplement 40 · standardAP
2024-10-31REMS · Supplement 41AP
2023-12-15Labeling · Supplement 39 · standardAP
2021-03-04Labeling · Supplement 38 · standardAP
2019-10-07Labeling · Supplement 35 · standardAP
2019-10-07Labeling · Supplement 36 · standardAP
2018-09-21Labeling · Supplement 32 · standardAP
2018-09-18REMS · Supplement 31 · standardAP
2017-08-29Labeling · Supplement 29 · standardAP
2016-12-16Labeling · Supplement 26 · standardAP
2016-12-16Labeling · Supplement 24 · standardAP
2016-12-16Labeling · Supplement 27 · standardAP
2013-10-18Labeling · Supplement 20 · standardAP
2013-05-10Labeling · Supplement 19 · standardAP
2011-06-22Labeling · Supplement 14AP
2008-02-11Labeling · Supplement 12AP
2007-10-18Labeling · Supplement 10AP
2007-01-10Labeling · Supplement 7AP
1995-03-16Labeling · Supplement 3AP
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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