APPLICATION
ANDA076494
TYPE
ANDA
ORIGINAL APPROVAL
2004-01-14
LATEST ACTION
2019-11-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
NAPROXENDiscontinued
NAPROXEN 375MG · TABLET · ORAL
NAPROXENDiscontinued
NAPROXEN 500MG · TABLET · ORAL
NAPROXENDiscontinued
NAPROXEN 250MG · TABLET · ORAL
Approval history
2019-11-26Labeling · Supplement 17 · standardAP
2019-11-26Labeling · Supplement 15 · standardAP
2019-11-26Labeling · Supplement 16 · standardAP
2015-04-16Labeling · Supplement 12 · standardAP
2010-04-16Labeling · Supplement 10AP
2006-08-08Labeling · Supplement 4AP
2005-06-09Labeling · Supplement 1AP
2004-01-14OriginalAP
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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