APPLICATION
ANDA085795
TYPE
ANDA
ORIGINAL APPROVAL
1978-01-20
LATEST ACTION
1998-12-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ACETAMINOPHEN AND CODEINE PHOSPHATEDiscontinued
ACETAMINOPHEN 300MG, CODEINE PHOSPHATE 15MG · TABLET · ORAL
Approval history
1998-12-01Manufacturing (CMC) · Supplement 32AP
1996-09-24Labeling · Supplement 31AP
1994-12-23Manufacturing (CMC) · Supplement 30AP
1992-04-03Manufacturing (CMC) · Supplement 29AP
1992-04-03Manufacturing (CMC) · Supplement 27AP
1991-11-05Labeling · Supplement 26AP
1990-05-31Labeling · Supplement 25AP
1989-06-09Labeling · Supplement 22AP
1988-09-22Labeling · Supplement 23AP
1988-03-03Manufacturing (CMC) · Supplement 19AP
1988-03-03Manufacturing (CMC) · Supplement 18AP
1988-02-17Manufacturing (CMC) · Supplement 9AP
1988-02-17Manufacturing (CMC) · Supplement 11AP
1988-02-17Manufacturing (CMC) · Supplement 12AP
1988-02-17Manufacturing (CMC) · Supplement 10AP
1987-03-20Manufacturing (CMC) · Supplement 16AP
1978-01-20OriginalAP
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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