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FDA ANDA · ANDA091238
ACETAMINOPHEN AND CODEINE PHOSPHATE
Sponsor: CHARTWELL MOLECULAR
APPLICATION
ANDA091238
TYPE
ANDA
ORIGINAL APPROVAL
2011-11-10
LATEST ACTION
2025-12-22
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
ACETAMINOPHEN AND CODEINE PHOSPHATEDiscontinued
ACETAMINOPHEN 120MG/5ML, CODEINE PHOSPHATE 12MG/5ML · SOLUTION · ORAL
Approval history
2025-12-22Labeling · Supplement 22 · standardAP
2025-12-05Labeling · Supplement 21 · standardAP
2023-12-15Labeling · Supplement 20 · standardAP
2021-03-04Labeling · Supplement 19 · standardAP
2019-10-07Labeling · Supplement 17 · standardAP
2018-09-21Labeling · Supplement 16 · standardAP
2018-09-18REMS · Supplement 15 · standardAP
2018-02-21Labeling · Supplement 13 · standardAP
2018-02-21Labeling · Supplement 14 · standardAP
2017-08-29Labeling · Supplement 12 · standardAP
2017-08-29Labeling · Supplement 11 · standardAP
2016-12-16Labeling · Supplement 10 · standardAP
2016-12-16Labeling · Supplement 9 · standardAP
2016-12-16Labeling · Supplement 8 · standardAP
2013-10-18Labeling · Supplement 7 · standardAP
2013-06-27Labeling · Supplement 5 · standardAP
2013-06-27Labeling · Supplement 4 · standardAP
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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