← FDA DRUG APPROVALS

FDA ANDA · ANDA087433

ACETAMINOPHEN AND CODEINE PHOSPHATE

Sponsor: SANDOZ

APPLICATION
ANDA087433
TYPE
ANDA
ORIGINAL APPROVAL
1981-07-22
LATEST ACTION
1988-10-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ACETAMINOPHEN AND CODEINE PHOSPHATE · ReferenceDiscontinued
ACETAMINOPHEN 300MG, CODEINE PHOSPHATE 15MG · TABLET · ORAL

Approval history

1988-10-14Labeling · Supplement 17AP
1985-09-19Manufacturing (CMC) · Supplement 9AP
1985-09-19Manufacturing (CMC) · Supplement 7AP
1983-05-18Manufacturing (CMC) · Supplement 1AP
1983-05-18Manufacturing (CMC) · Supplement 2AP
1982-12-07Manufacturing (CMC) · Supplement 4AP
1981-07-22OriginalAP
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 →