APPLICATION
ANDA075061
TYPE
ANDA
ORIGINAL APPROVAL
1998-02-18
LATEST ACTION
2015-07-20
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Discontinued
Products
NAPROXENDiscontinued
NAPROXEN 500MG · TABLET, DELAYED RELEASE · ORAL
NAPROXENDiscontinued
NAPROXEN 375MG · TABLET, DELAYED RELEASE · ORAL
Approval history
2015-07-20Labeling · Supplement 27 · standardAP
2008-10-29Labeling · Supplement 23AP
2008-04-29Labeling · Supplement 20AP
2007-11-28Labeling · Supplement 19AP
2007-07-15Labeling · Supplement 16AP
2003-12-10Labeling · Supplement 12AP
2002-05-10Manufacturing (CMC) · Supplement 4AP
2002-05-10Manufacturing (CMC) · Supplement 5AP
2001-10-03Manufacturing (CMC) · Supplement 2AP
2001-10-03Manufacturing (CMC) · Supplement 3AP
2000-08-02Manufacturing (CMC) · Supplement 1AP
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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