APPLICATION
ANDA074635
TYPE
ANDA
ORIGINAL APPROVAL
1997-01-13
LATEST ACTION
2006-03-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter
Products
NAPROXEN SODIUMOver-the-counter
NAPROXEN SODIUM 220MG · TABLET · ORAL
Approval history
2006-03-13Labeling · Supplement 17AP
2002-09-04Manufacturing (CMC) · Supplement 15AP
2002-04-29Manufacturing (CMC) · Supplement 13AP
2002-04-29Manufacturing (CMC) · Supplement 14AP
2000-09-21Manufacturing (CMC) · Supplement 12AP
2000-08-02Manufacturing (CMC) · Supplement 10AP
2000-03-03Manufacturing (CMC) · Supplement 7AP
2000-03-03Manufacturing (CMC) · Supplement 6AP
1999-08-24Labeling · Supplement 8AP
1999-04-14Manufacturing (CMC) · Supplement 1AP
1999-02-11Manufacturing (CMC) · Supplement 5AP
1999-02-11Manufacturing (CMC) · Supplement 4AP
1998-12-07Manufacturing (CMC) · Supplement 2AP
1998-04-28Manufacturing (CMC) · Supplement 3AP
1997-01-13OriginalAP
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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