APPLICATION
ANDA084656
TYPE
ANDA
ORIGINAL APPROVAL
1976-05-10
LATEST ACTION
2000-12-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ACETAMINOPHEN AND CODEINE PHOSPHATEDiscontinued
ACETAMINOPHEN 300MG, CODEINE PHOSPHATE 30MG · TABLET · ORAL
Approval history
2000-12-28Manufacturing (CMC) · Supplement 50AP
1996-08-28Manufacturing (CMC) · Supplement 49AP
1995-03-15Labeling · Supplement 48AP
1994-09-28Labeling · Supplement 47AP
1993-12-16Labeling · Supplement 46AP
1990-10-03Labeling · Supplement 43AP
1989-12-05Labeling · Supplement 42AP
1989-03-01Labeling · Supplement 37AP
1989-01-03Manufacturing (CMC) · Supplement 40AP
1984-04-06Manufacturing (CMC) · Supplement 35AP
1976-05-10OriginalAP
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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