APPLICATION
ANDA074105
TYPE
ANDA
ORIGINAL APPROVAL
1993-12-21
LATEST ACTION
1997-10-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
NAPROXENDiscontinued
NAPROXEN 500MG · TABLET · ORAL
NAPROXENDiscontinued
NAPROXEN 250MG · TABLET · ORAL
NAPROXENDiscontinued
NAPROXEN 375MG · TABLET · ORAL
Approval history
1997-10-30Manufacturing (CMC) · Supplement 5AP
1997-09-22Manufacturing (CMC) · Supplement 4AP
1996-07-26Manufacturing (CMC) · Supplement 3AP
1996-02-29Labeling · Supplement 2AP
1995-05-22Manufacturing (CMC) · Supplement 1AP
1993-12-21OriginalAP
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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