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FDA ANDA · ANDA074410

NAPROXEN

Sponsor: CHARTWELL MOLECULES

APPLICATION
ANDA074410
TYPE
ANDA
ORIGINAL APPROVAL
1995-04-28
LATEST ACTION
2017-01-09
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

2017-01-09Labeling · Supplement 24 · standardAP
2006-02-17Labeling · Supplement 14AP
2006-01-31Labeling · Supplement 13AP
2002-11-19Manufacturing (CMC) · Supplement 7AP
2002-11-19Labeling · Supplement 8AP
2002-03-19Manufacturing (CMC) · Supplement 6AP
2001-10-09Manufacturing (CMC) · Supplement 3AP
2001-10-09Manufacturing (CMC) · Supplement 4AP
2001-08-27Manufacturing (CMC) · Supplement 5AP
1999-11-24Manufacturing (CMC) · Supplement 2AP
1997-03-04Manufacturing (CMC) · Supplement 1AP
1995-04-28OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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