APPLICATION
ANDA085055
TYPE
ANDA
ORIGINAL APPROVAL
1977-08-17
LATEST ACTION
2019-11-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TYLENOL W/ CODEINE NO. 3 · ReferenceDiscontinued
ACETAMINOPHEN 300MG, CODEINE PHOSPHATE 30MG · TABLET · ORAL
TYLENOL W/ CODEINE NO. 1Discontinued
ACETAMINOPHEN 300MG, CODEINE PHOSPHATE 7.5MG · TABLET · ORAL
TYLENOL W/ CODEINE NO. 4 · ReferenceDiscontinued
ACETAMINOPHEN 300MG, CODEINE PHOSPHATE 60MG · TABLET · ORAL
TYLENOL W/ CODEINE NO. 2 · ReferenceDiscontinued
ACETAMINOPHEN 300MG, CODEINE PHOSPHATE 15MG · TABLET · ORAL
Approval history
2019-11-18Labeling · Supplement 63 · standardAP
2019-10-29Labeling · Supplement 64 · standardAP
2019-05-06Labeling · Supplement 56 · standardAP
2019-05-06Labeling · Supplement 62 · standardAP
2018-09-20Labeling · Supplement 61 · standardAP
2018-09-18REMS · Supplement 60AP
2017-08-29Labeling · Supplement 59 · standardAP
2017-03-24Labeling · Supplement 58 · standardAP
2016-12-16Labeling · Supplement 57 · standardAP
2014-08-15Labeling · Supplement 54 · standardAP
2013-05-10Labeling · Supplement 53 · standardAP
2011-09-15Labeling · Supplement 52AP
2008-07-11Labeling · Supplement 50AP
2007-10-31Labeling · Supplement 49AP
2001-05-31Manufacturing (CMC) · Supplement 46AP
2000-11-02Manufacturing (CMC) · Supplement 44AP
2000-11-02Manufacturing (CMC) · Supplement 43AP
1994-09-23Manufacturing (CMC) · Supplement 40AP
1993-09-24Manufacturing (CMC) · Supplement 39AP
1992-11-12Manufacturing (CMC) · Supplement 36AP
1991-05-07Labeling · Supplement 35AP
1991-03-15Labeling · Supplement 34AP
1990-08-31Manufacturing (CMC) · Supplement 31AP
1990-08-31Labeling · Supplement 32AP
1990-08-31Manufacturing (CMC) · Supplement 30AP
1988-12-23Labeling · Supplement 29AP
1986-12-04Manufacturing (CMC) · Supplement 21AP
1986-12-04Manufacturing (CMC) · Supplement 24AP
1986-12-04Manufacturing (CMC) · Supplement 22AP
1983-10-21Manufacturing (CMC) · Supplement 17AP
1983-10-21Manufacturing (CMC) · Supplement 18AP
1983-08-11Manufacturing (CMC) · Supplement 15AP
1982-12-08Manufacturing (CMC) · Supplement 8AP
1982-12-08Manufacturing (CMC) · Supplement 6AP
1982-12-08Manufacturing (CMC) · Supplement 9AP
1982-12-08Manufacturing (CMC) · Supplement 7AP
1981-12-30Manufacturing (CMC) · Supplement 5AP
1977-08-17OriginalAP
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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