APPLICATION
ANDA074936
TYPE
ANDA
ORIGINAL APPROVAL
1998-02-24
LATEST ACTION
2001-11-02
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
2001-11-02Manufacturing (CMC) · Supplement 2AP
2001-03-05Manufacturing (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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