APPLICATION
ANDA074195
TYPE
ANDA
ORIGINAL APPROVAL
1993-12-21
LATEST ACTION
2001-06-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
NAPROXEN SODIUMDiscontinued
NAPROXEN SODIUM EQ 250MG BASE · TABLET · ORAL
NAPROXEN SODIUMDiscontinued
NAPROXEN SODIUM EQ 500MG BASE · TABLET · ORAL
Approval history
2001-06-08Manufacturing (CMC) · Supplement 8AP
2001-06-08Manufacturing (CMC) · Supplement 7AP
2001-04-25Manufacturing (CMC) · Supplement 6AP
2000-12-04Manufacturing (CMC) · Supplement 2AP
2000-12-04Manufacturing (CMC) · Supplement 5AP
2000-12-04Manufacturing (CMC) · Supplement 3AP
1995-07-13Labeling · 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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