← FDA DRUG APPROVALS

FDA ANDA · ANDA078486

NAPROXEN SODIUM

Sponsor: DR REDDYS LABS LTD

APPLICATION
ANDA078486
TYPE
ANDA
ORIGINAL APPROVAL
2007-07-26
LATEST ACTION
2025-06-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

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

Approval history

2025-06-10Labeling · Supplement 11 · standardAP
2025-06-10Labeling · Supplement 10 · standardAP
2025-06-10Labeling · Supplement 8 · standardAP
2019-12-10Labeling · Supplement 7 · standardAP
2019-12-10Labeling · Supplement 3 · standardAP
2019-12-10Labeling · Supplement 4 · standardAP
2019-12-10Labeling · Supplement 2 · standardAP
2008-10-14Labeling · Supplement 1AP
2007-07-26Original — Other Important Information from FDA ↗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 →