← FDA DRUG APPROVALS
FDA ANDA · ANDA088355
ACETAMINOPHEN AND CODEINE PHOSPHATE
Sponsor: DURAMED PHARMS BARR
APPLICATION
ANDA088355
TYPE
ANDA
ORIGINAL APPROVAL
1984-02-06
LATEST ACTION
1984-06-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ACETAMINOPHEN AND CODEINE PHOSPHATEDiscontinued
ACETAMINOPHEN 300MG, CODEINE PHOSPHATE 60MG · TABLET · ORAL
Approval history
1984-06-11Manufacturing (CMC) · Supplement 1AP
1984-02-06OriginalAP
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.