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FDA ANDA · ANDA089990
ACETAMINOPHEN AND CODEINE PHOSPHATE
Sponsor: STRIDES PHARMA INTL
APPLICATION
ANDA089990
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 15MG · TABLET · ORAL
Approval history
2026-06-18REMS · Supplement 41AP
2025-12-22Labeling · Supplement 40 · standardAP
2025-03-10Labeling · Supplement 35 · standardAP
2024-10-31REMS · Supplement 36AP
2023-12-15Labeling · Supplement 34 · standardAP
2021-03-04Labeling · Supplement 33 · standardAP
2019-10-07Labeling · Supplement 30 · standardAP
2019-10-07Labeling · Supplement 31 · standardAP
2018-09-21Labeling · Supplement 28 · standardAP
2018-09-18REMS · Supplement 26 · standardAP
2017-08-29Labeling · Supplement 24 · standardAP
2016-12-16Labeling · Supplement 22 · standardAP
2016-12-16Labeling · Supplement 19 · standardAP
2016-12-16Labeling · Supplement 21 · standardAP
2013-10-18Labeling · Supplement 15 · standardAP
2013-05-10Labeling · Supplement 14 · standardAP
2011-06-22Labeling · Supplement 8AP
2008-02-11Labeling · Supplement 6AP
2007-10-25Labeling · Supplement 5AP
2007-03-26Labeling · Supplement 4AP
1995-03-16Labeling · 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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