APPLICATION
ANDA086366
TYPE
ANDA
ORIGINAL APPROVAL
1979-03-27
LATEST ACTION
1999-03-12
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
ACETAMINOPHEN AND CODEINE PHOSPHATEDiscontinued
ACETAMINOPHEN 120MG/5ML, CODEINE PHOSPHATE 12MG/5ML · SOLUTION · ORAL
Approval history
1999-03-12Manufacturing (CMC) · Supplement 32AP
1999-02-16Manufacturing (CMC) · Supplement 30AP
1996-09-09Manufacturing (CMC) · Supplement 29AP
1996-09-09Manufacturing (CMC) · Supplement 25AP
1996-09-09Manufacturing (CMC) · Supplement 28AP
1996-09-09Labeling · Supplement 26AP
1996-08-28Manufacturing (CMC) · Supplement 27AP
1995-03-15Labeling · Supplement 24AP
1994-09-28Labeling · Supplement 23AP
1993-12-16Labeling · Supplement 22AP
1991-02-13Manufacturing (CMC) · Supplement 19AP
1991-02-13Manufacturing (CMC) · Supplement 20AP
1990-10-03Labeling · Supplement 21AP
1990-10-03Labeling · Supplement 18AP
1989-07-13Labeling · Supplement 16AP
1988-05-13Manufacturing (CMC) · Supplement 15AP
1988-05-13Manufacturing (CMC) · Supplement 14AP
1987-07-08Manufacturing (CMC) · Supplement 10AP
1987-07-08Manufacturing (CMC) · Supplement 9AP
1984-04-10Manufacturing (CMC) · Supplement 7AP
1979-03-27OriginalAP
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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