← FDA DRUG APPROVALS

FDA ANDA · ANDA074257

NAPROXEN SODIUM

Sponsor: ROXANE

APPLICATION
ANDA074257
TYPE
ANDA
ORIGINAL APPROVAL
1993-12-21
LATEST ACTION
1996-08-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

NAPROXEN SODIUMDiscontinued
NAPROXEN SODIUM EQ 250MG BASE · TABLET · ORAL
NAPROXEN SODIUMDiscontinued
NAPROXEN SODIUM EQ 500MG BASE · TABLET · ORAL

Approval history

1996-08-28Manufacturing (CMC) · Supplement 2AP
1996-05-17Labeling · 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 →