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FDA ANDA · ANDA074111

NAPROXEN

Sponsor: IVAX SUB TEVA PHARMS

APPLICATION
ANDA074111
TYPE
ANDA
ORIGINAL APPROVAL
1995-02-28
LATEST ACTION
2002-07-29
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

2002-07-29Manufacturing (CMC) · Supplement 3AP
2000-01-28Manufacturing (CMC) · Supplement 2AP
1996-12-02Labeling · Supplement 1AP
1995-02-28OriginalAP
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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