← FDA DRUG APPROVALS

FDA ANDA · ANDA085917

ACETAMINOPHEN AND CODEINE PHOSPHATE

Sponsor: SANDOZ

APPLICATION
ANDA085917
TYPE
ANDA
ORIGINAL APPROVAL
1980-08-12
LATEST ACTION
1988-10-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

1988-10-14Labeling · Supplement 30AP
1985-09-19Manufacturing (CMC) · Supplement 18AP
1985-09-19Manufacturing (CMC) · Supplement 20AP
1983-09-16Manufacturing (CMC) · Supplement 17AP
1983-05-17Manufacturing (CMC) · Supplement 16AP
1983-05-17Manufacturing (CMC) · Supplement 14AP
1983-05-17Manufacturing (CMC) · Supplement 13AP
1982-10-12Manufacturing (CMC) · Supplement 12AP
1982-04-08Manufacturing (CMC) · Supplement 15AP
1980-08-12OriginalAP
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 →