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FDA ANDA · ANDA074230

NAPROXEN SODIUM

Sponsor: IVAX SUB TEVA PHARMS

APPLICATION
ANDA074230
TYPE
ANDA
ORIGINAL APPROVAL
1995-03-14
LATEST ACTION
2002-07-29
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

2002-07-29Manufacturing (CMC) · Supplement 3AP
2000-01-28Manufacturing (CMC) · Supplement 2AP
1996-12-02Labeling · Supplement 1AP
1995-03-14OriginalAP
VIEW ON DRUGS@FDA ↗

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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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