← FDA DRUG APPROVALS

FDA ANDA · ANDA085291

ACETAMINOPHEN AND CODEINE PHOSPHATE

Sponsor: SANDOZ

APPLICATION
ANDA085291
TYPE
ANDA
ORIGINAL APPROVAL
1977-02-10
LATEST ACTION
1991-02-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

1991-02-01Labeling · Supplement 65AP
1989-08-01Labeling · Supplement 64AP
1989-04-11Labeling · Supplement 63AP
1977-02-10OriginalAP
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 →