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FDA ANDA · ANDA085861
ACETAMINOPHEN AND CODEINE PHOSPHATE
Sponsor: ACTAVIS MID ATLANTIC
APPLICATION
ANDA085861
TYPE
ANDA
ORIGINAL APPROVAL
1978-06-20
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
ACETAMINOPHEN AND CODEINE PHOSPHATE · ReferenceDiscontinued
ACETAMINOPHEN 120MG/5ML, CODEINE PHOSPHATE 12MG/5ML · SOLUTION · ORAL
Approval history
2026-06-18REMS · Supplement 85AP
2025-12-22Labeling · Supplement 82 · standardAP
2025-12-22Labeling · Supplement 84 · standardAP
2024-10-31REMS · Supplement 83AP
2023-12-15Labeling · Supplement 80 · standardAP
2023-12-15Labeling · Supplement 81 · standardAP
2021-03-04Labeling · Supplement 79 · standardAP
2019-10-07Labeling · Supplement 78 · standardAP
2018-09-20Labeling · Supplement 76 · standardAP
2018-09-18REMS · Supplement 77AP
2018-01-30Labeling · Supplement 75 · standardAP
2017-08-29Labeling · Supplement 74 · standardAP
2017-02-14Labeling · Supplement 71 · standardAP
2016-12-16Labeling · Supplement 72 · standardAP
2016-12-16Labeling · Supplement 73 · standardAP
2015-11-04Labeling · Supplement 70 · standardAP
2011-06-22Labeling · Supplement 69AP
2008-06-27Labeling · Supplement 68AP
2001-04-02Manufacturing (CMC) · Supplement 47AP
2000-09-05Manufacturing (CMC) · Supplement 46AP
1997-10-02Manufacturing (CMC) · Supplement 44AP
1994-09-22Manufacturing (CMC) · Supplement 42AP
1994-08-24Labeling · Supplement 43AP
1993-07-16Manufacturing (CMC) · Supplement 40AP
1993-07-16Manufacturing (CMC) · Supplement 39AP
1993-03-29Manufacturing (CMC) · Supplement 38AP
1993-03-04Labeling · Supplement 41AP
1992-04-06Manufacturing (CMC) · Supplement 30AP
1991-04-03Manufacturing (CMC) · Supplement 35AP
1990-11-08Labeling · Supplement 29AP
1990-11-08Labeling · Supplement 33AP
1990-09-14Manufacturing (CMC) · Supplement 23AP
1990-09-14Manufacturing (CMC) · Supplement 24AP
1990-05-18Labeling · Supplement 28AP
1990-05-18Labeling · Supplement 26AP
1990-05-18Labeling · Supplement 18AP
1989-03-16Labeling · Supplement 25AP
1989-02-08Manufacturing (CMC) · Supplement 21AP
1989-02-08Manufacturing (CMC) · Supplement 20AP
1988-05-11Labeling · Supplement 19AP
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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