APPLICATION
ANDA081249
TYPE
ANDA
ORIGINAL APPROVAL
1992-07-16
LATEST ACTION
2025-12-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ACETAMINOPHEN AND CODEINE PHOSPHATEDiscontinued
ACETAMINOPHEN 300MG, CODEINE PHOSPHATE 60MG · TABLET · ORAL
Approval history
2025-12-22Labeling · Supplement 16 · standardAP
2024-10-31REMS · Supplement 15AP
2023-12-15Labeling · Supplement 14 · standardAP
2021-03-04Labeling · Supplement 13 · standardAP
2019-10-07Labeling · Supplement 12 · standardAP
2018-09-20Labeling · Supplement 10 · standardAP
2018-09-18REMS · Supplement 11AP
2017-08-29Labeling · Supplement 8 · standardAP
2017-08-29Labeling · Supplement 9 · standardAP
2016-12-16Labeling · Supplement 6 · standardAP
2016-12-16Labeling · Supplement 7 · standardAP
2014-12-23Labeling · Supplement 4 · standardAP
2014-05-21Labeling · Supplement 5 · standardAP
1997-08-11Manufacturing (CMC) · Supplement 2AP
1994-01-24Manufacturing (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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