APPLICATION
ANDA085365
TYPE
ANDA
ORIGINAL APPROVAL
1977-08-23
LATEST ACTION
1996-12-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ACETAMINOPHEN AND CODEINE PHOSPHATEDiscontinued
ACETAMINOPHEN 300MG, CODEINE PHOSPHATE 60MG · TABLET · ORAL
Approval history
1996-12-12Labeling · Supplement 31AP
1991-03-22Labeling · Supplement 35AP
1988-05-04Labeling · Supplement 30AP
1977-08-23OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.