← FDA DRUG APPROVALS

FDA ANDA · ANDA084360

ACETAMINOPHEN AND CODEINE PHOSPHATE

Sponsor: WHITEWORTH TOWN PLSN

APPLICATION
ANDA084360
TYPE
ANDA
ORIGINAL APPROVAL
1977-12-19
LATEST ACTION
1985-06-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

1985-06-03Manufacturing (CMC) · Supplement 6AP
1982-07-22Manufacturing (CMC) · Supplement 4AP
1977-12-19OriginalAP
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 →