APPLICATION
ANDA075168
TYPE
ANDA
ORIGINAL APPROVAL
1998-07-28
LATEST ACTION
2010-12-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter
Products
NAPROXEN SODIUMOver-the-counter
NAPROXEN SODIUM 220MG · TABLET · ORAL
Approval history
2010-12-13Labeling · Supplement 11AP
2009-07-10Labeling · Supplement 8AP
2008-03-16Labeling · Supplement 5AP
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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