APPLICATION
ANDA074480
TYPE
ANDA
ORIGINAL APPROVAL
1996-05-14
LATEST ACTION
2008-09-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
NAPROXEN SODIUMDiscontinued
NAPROXEN SODIUM EQ 250MG BASE · TABLET · ORAL
NAPROXEN SODIUMDiscontinued
NAPROXEN SODIUM EQ 500MG BASE · TABLET · ORAL
Approval history
2008-09-08Labeling · Supplement 27AP
2008-05-08Labeling · Supplement 24AP
2007-10-16Labeling · Supplement 23AP
2006-10-05Labeling · Supplement 22AP
2006-06-07Labeling · Supplement 21AP
2005-06-09Labeling · Supplement 17AP
1999-04-09Manufacturing (CMC) · Supplement 14AP
1998-10-01Manufacturing (CMC) · Supplement 13AP
1998-03-06Labeling · Supplement 4AP
1998-03-06Manufacturing (CMC) · Supplement 2AP
1998-03-06Manufacturing (CMC) · Supplement 3AP
1998-03-06Manufacturing (CMC) · Supplement 1AP
1998-02-18Manufacturing (CMC) · Supplement 11AP
1998-02-18Manufacturing (CMC) · Supplement 8AP
1998-02-18Manufacturing (CMC) · Supplement 6AP
1998-02-18Manufacturing (CMC) · Supplement 12AP
1998-02-18Manufacturing (CMC) · Supplement 10AP
1998-02-18Manufacturing (CMC) · Supplement 9AP
1998-02-18Labeling · Supplement 7AP
1997-03-14Manufacturing (CMC) · Supplement 5AP
1996-05-14OriginalAP
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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