← FDA DRUG APPROVALS

FDA ANDA · ANDA076200

ACETAMINOPHEN

Sponsor: OHM LABS

APPLICATION
ANDA076200
TYPE
ANDA
ORIGINAL APPROVAL
2002-03-19
LATEST ACTION
2015-12-23
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Over-the-counter

Products

ACETAMINOPHENOver-the-counter
ACETAMINOPHEN 650MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2015-12-23Labeling · Supplement 22 · standardAP
2014-09-25Labeling · Supplement 20 · standardAP
2014-09-25Labeling · Supplement 19AP
2014-09-25Labeling · Supplement 21 · standardAP
2010-07-28Labeling · Supplement 16AP
2010-01-22Labeling · Supplement 15AP
2009-11-23Labeling · Supplement 14AP
2009-02-17Labeling · Supplement 12AP
2004-08-11Supplement · Supplement 5 — Review ↗AP
2002-12-03Manufacturing (CMC) · Supplement 4 — Review ↗AP
2002-12-03Manufacturing (CMC) · Supplement 2 — Review ↗AP
2002-12-03Manufacturing (CMC) · Supplement 3 — Review ↗AP
2002-10-15Manufacturing (CMC) · Supplement 1 — Review ↗AP
2002-03-19Original — Letter ↗AP
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 →