APPLICATION
ANDA040119
TYPE
ANDA
ORIGINAL APPROVAL
1996-04-26
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
ACETAMINOPHEN AND CODEINE PHOSPHATEDiscontinued
ACETAMINOPHEN 120MG/5ML, CODEINE PHOSPHATE 12MG/5ML · SOLUTION · ORAL
Approval history
2026-06-18REMS · Supplement 24AP
2025-12-22Labeling · Supplement 23 · standardAP
2024-10-31REMS · Supplement 22AP
2024-02-08Labeling · Supplement 20 · standardAP
2024-02-08Labeling · Supplement 21 · standardAP
2021-03-04Labeling · Supplement 18 · standardAP
2019-10-07Labeling · Supplement 15 · standardAP
2018-09-20Labeling · Supplement 14 · standardAP
2018-09-18REMS · Supplement 13AP
2018-01-29Labeling · Supplement 12 · standardAP
2017-08-29Labeling · Supplement 10 · standardAP
2017-08-29Labeling · Supplement 11 · standardAP
2016-12-16Labeling · Supplement 8 · standardAP
2016-12-16Labeling · Supplement 9 · standardAP
2014-11-12Manufacturing (CMC) · Supplement 4AP
2013-10-22Labeling · Supplement 6 · standardAP
2013-05-16Labeling · Supplement 5 · standardAP
2011-06-23Labeling · Supplement 3AP
2007-11-30Labeling · Supplement 2AP
2007-09-12Labeling · 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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