APPLICATION
ANDA074163
TYPE
ANDA
ORIGINAL APPROVAL
1995-02-10
LATEST ACTION
2001-08-24
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
2001-08-24Manufacturing (CMC) · Supplement 8AP
2001-04-25Manufacturing (CMC) · Supplement 9AP
2000-02-03Manufacturing (CMC) · Supplement 7AP
2000-02-03Manufacturing (CMC) · Supplement 5AP
2000-02-03Manufacturing (CMC) · Supplement 6AP
1999-03-04Manufacturing (CMC) · Supplement 3AP
1999-03-04Manufacturing (CMC) · Supplement 2AP
1995-07-13Labeling · Supplement 1AP
1995-02-10OriginalAP
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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