← FDA DRUG APPROVALS

FDA ANDA · ANDA089244

ACETAMINOPHEN AND CODEINE PHOSPHATE

Sponsor: MIKART

APPLICATION
ANDA089244
TYPE
ANDA
ORIGINAL APPROVAL
1986-02-25
LATEST ACTION
2002-08-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ACETAMINOPHEN AND CODEINE PHOSPHATEDiscontinued
ACETAMINOPHEN 300MG, CODEINE PHOSPHATE 60MG · TABLET · ORAL

Approval history

2002-08-13Manufacturing (CMC) · Supplement 19AP
1998-07-31Manufacturing (CMC) · Supplement 18AP
1997-05-07Manufacturing (CMC) · Supplement 16AP
1997-05-07Manufacturing (CMC) · Supplement 14AP
1997-05-07Labeling · Supplement 17AP
1997-05-07Manufacturing (CMC) · Supplement 15AP
1997-05-07Manufacturing (CMC) · Supplement 13AP
1995-05-30Labeling · Supplement 12AP
1993-07-20Manufacturing (CMC) · Supplement 10AP
1991-09-16Labeling · Supplement 3AP
1988-10-21Manufacturing (CMC) · Supplement 9AP
1988-06-20Manufacturing (CMC) · Supplement 6AP
1988-06-20Manufacturing (CMC) · Supplement 5AP
1988-02-18Manufacturing (CMC) · Supplement 4AP
1987-06-04Manufacturing (CMC) · Supplement 2AP
1986-11-06Manufacturing (CMC) · Supplement 1AP
1986-02-25OriginalAP
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 →