APPLICATION
ANDA089998
TYPE
ANDA
ORIGINAL APPROVAL
1994-12-28
LATEST ACTION
2025-12-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ACETAMINOPHEN AND CODEINE PHOSPHATEDiscontinued
ACETAMINOPHEN 300MG, CODEINE PHOSPHATE 30MG · TABLET · ORAL
Approval history
2025-12-22Labeling · Supplement 28 · standardAP
2025-07-30Labeling · Supplement 27 · standardAP
2023-12-15Labeling · Supplement 26 · standardAP
2023-12-15Labeling · Supplement 25 · standardAP
2021-03-04Labeling · Supplement 24 · standardAP
2019-10-09Labeling · Supplement 23 · standardAP
2018-09-21Labeling · Supplement 22 · standardAP
2018-09-18REMS · Supplement 21AP
2017-08-29Labeling · Supplement 20 · standardAP
2016-12-16Labeling · Supplement 18 · standardAP
2016-12-16Labeling · Supplement 19 · standardAP
2015-11-03Labeling · Supplement 16 · standardAP
2001-08-29Manufacturing (CMC) · Supplement 12AP
2001-04-12Manufacturing (CMC) · Supplement 11AP
2000-11-17Manufacturing (CMC) · Supplement 8AP
2000-11-17Manufacturing (CMC) · Supplement 6AP
2000-11-17Labeling · Supplement 9AP
2000-11-17Manufacturing (CMC) · Supplement 7AP
2000-11-17Manufacturing (CMC) · Supplement 5AP
2000-03-21Manufacturing (CMC) · Supplement 10AP
1998-08-21Manufacturing (CMC) · Supplement 4AP
1997-07-08Manufacturing (CMC) · Supplement 2AP
1996-08-28Manufacturing (CMC) · Supplement 1AP
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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