APPLICATION
ANDA091305
TYPE
ANDA
ORIGINAL APPROVAL
2011-08-24
LATEST ACTION
2019-10-25
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
2019-10-25Labeling · Supplement 13 · standardAP
2019-10-25Labeling · Supplement 11 · standardAP
2016-08-03Labeling · Supplement 6 · standardAP
2016-08-03Labeling · Supplement 5 · standardAP
2011-08-24OriginalAP
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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