← FDA DRUG APPROVALS

FDA ANDA · ANDA088354

ACETAMINOPHEN AND CODEINE PHOSPHATE

Sponsor: DURAMED PHARMS BARR

APPLICATION
ANDA088354
TYPE
ANDA
ORIGINAL APPROVAL
1984-02-06
LATEST ACTION
1987-11-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ACETAMINOPHEN AND CODEINE PHOSPHATEDiscontinued
ACETAMINOPHEN 300MG, CODEINE PHOSPHATE 30MG · TABLET · ORAL

Approval history

1987-11-30Manufacturing (CMC) · Supplement 10AP
1987-03-18Manufacturing (CMC) · Supplement 12AP
1987-03-18Manufacturing (CMC) · Supplement 7AP
1984-06-11Manufacturing (CMC) · Supplement 1AP
1984-02-06OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →