APPLICATION
ANDA074198
TYPE
ANDA
ORIGINAL APPROVAL
1993-12-21
LATEST ACTION
2020-08-13
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
2020-08-13Labeling · Supplement 37 · standardAP
2020-08-13Labeling · Supplement 38 · standardAP
2020-08-13Labeling · Supplement 40 · standardAP
2015-04-15Labeling · Supplement 35 · standardAP
2008-06-28Labeling · Supplement 30AP
2006-05-19Labeling · Supplement 28AP
2006-02-17Labeling · Supplement 27AP
2001-08-22Manufacturing (CMC) · Supplement 17AP
2000-05-24Manufacturing (CMC) · Supplement 16AP
1999-12-02Manufacturing (CMC) · Supplement 14AP
1999-12-02Manufacturing (CMC) · Supplement 13AP
1999-02-12Manufacturing (CMC) · Supplement 8AP
1999-02-12Manufacturing (CMC) · Supplement 9AP
1998-06-09Manufacturing (CMC) · Supplement 7AP
1997-01-15Manufacturing (CMC) · Supplement 6AP
1997-01-15Manufacturing (CMC) · Supplement 4AP
1997-01-15Manufacturing (CMC) · Supplement 5AP
1996-08-16Manufacturing (CMC) · Supplement 3AP
1995-10-17Labeling · Supplement 2AP
1995-02-17Manufacturing (CMC) · Supplement 1AP
1993-12-21OriginalAP
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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