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FDA ANDA · ANDA074455

NAPROXEN SODIUM

Sponsor: WATSON LABS

APPLICATION
ANDA074455
TYPE
ANDA
ORIGINAL APPROVAL
1995-05-31
LATEST ACTION
2006-03-02
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

2006-03-02Labeling · Supplement 6AP
1997-10-29Manufacturing (CMC) · Supplement 4AP
1997-10-29Manufacturing (CMC) · Supplement 2AP
1997-10-29Manufacturing (CMC) · Supplement 3AP
1997-10-29Manufacturing (CMC) · Supplement 1AP
1995-05-31OriginalAP
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.

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