APPLICATION
ANDA074789
TYPE
ANDA
ORIGINAL APPROVAL
1997-02-27
LATEST ACTION
2006-03-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
NAPROXEN SODIUMDiscontinued
NAPROXEN SODIUM 220MG · TABLET · ORAL
Approval history
2006-03-13Labeling · Supplement 6AP
2001-03-12Manufacturing (CMC) · Supplement 2AP
1999-12-13Labeling · Supplement 3AP
1997-08-11Manufacturing (CMC) · Supplement 1AP
1997-02-27OriginalAP
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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