APPLICATION
ANDA085883
TYPE
ANDA
ORIGINAL APPROVAL
1979-01-08
LATEST ACTION
2016-12-16
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued
Products
CAPITAL AND CODEINEDiscontinued
ACETAMINOPHEN 120MG/5ML, CODEINE PHOSPHATE 12MG/5ML · SUSPENSION · ORAL
Approval history
2016-12-16Labeling · Supplement 40 · standardAP
2016-12-16Labeling · Supplement 41 · standardAP
2015-11-04Labeling · Supplement 38 · standardAP
2011-06-22Labeling · Supplement 37AP
2001-09-07Manufacturing (CMC) · Supplement 29AP
2000-03-22Manufacturing (CMC) · Supplement 28AP
1998-10-07Manufacturing (CMC) · Supplement 26AP
1998-10-07Manufacturing (CMC) · Supplement 27AP
1996-11-27Manufacturing (CMC) · Supplement 24AP
1996-07-15Labeling · Supplement 23AP
1994-09-22Manufacturing (CMC) · Supplement 22AP
1994-02-25Labeling · Supplement 21AP
1992-12-03Manufacturing (CMC) · Supplement 19AP
1991-10-08Manufacturing (CMC) · Supplement 20AP
1990-09-28Manufacturing (CMC) · Supplement 18AP
1990-02-21Labeling · Supplement 17AP
1989-11-02Labeling · Supplement 16AP
1989-11-02Labeling · Supplement 11AP
1979-01-08OriginalAP
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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