← FDA DRUG APPROVALS

FDA ANDA · ANDA074207

NAPROXEN

Sponsor: TEVA PHARMS

APPLICATION
ANDA074207
TYPE
ANDA
ORIGINAL APPROVAL
1993-12-21
LATEST ACTION
1999-03-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

NAPROXENDiscontinued
NAPROXEN 375MG · TABLET · ORAL
NAPROXENDiscontinued
NAPROXEN 500MG · TABLET · ORAL
NAPROXENDiscontinued
NAPROXEN 250MG · TABLET · ORAL

Approval history

1999-03-23Manufacturing (CMC) · Supplement 12AP
1998-02-25Manufacturing (CMC) · Supplement 11AP
1997-12-15Manufacturing (CMC) · Supplement 9AP
1997-12-15Manufacturing (CMC) · Supplement 8AP
1997-12-15Manufacturing (CMC) · Supplement 10AP
1997-12-15Manufacturing (CMC) · Supplement 6AP
1997-04-08Manufacturing (CMC) · Supplement 7AP
1997-04-08Manufacturing (CMC) · Supplement 3AP
1997-04-08Manufacturing (CMC) · Supplement 4AP
1997-01-07Manufacturing (CMC) · Supplement 5AP
1996-05-31Manufacturing (CMC) · Supplement 2AP
1995-06-14Manufacturing (CMC) · Supplement 1AP
1993-12-21OriginalAP
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 →