← FDA DRUG APPROVALS

FDA ANDA · ANDA074442

GEMFIBROZIL

Sponsor: WATSON LABS

APPLICATION
ANDA074442
TYPE
ANDA
ORIGINAL APPROVAL
1995-04-28
LATEST ACTION
2004-09-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

GEMFIBROZILDiscontinued
GEMFIBROZIL 600MG · TABLET · ORAL

Approval history

2004-09-21Labeling · Supplement 9AP
1998-08-17Manufacturing (CMC) · Supplement 8AP
1998-08-17Manufacturing (CMC) · Supplement 7AP
1997-10-17Manufacturing (CMC) · Supplement 4AP
1997-10-17Manufacturing (CMC) · Supplement 5AP
1997-10-17Manufacturing (CMC) · Supplement 3AP
1997-07-08Labeling · Supplement 6AP
1997-07-08Manufacturing (CMC) · Supplement 2AP
1996-04-10Labeling · Supplement 1AP
1995-04-28OriginalAP
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 →