APPLICATION
ANDA074289
TYPE
ANDA
ORIGINAL APPROVAL
1994-01-27
LATEST ACTION
2021-03-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
NAPROXEN SODIUMDiscontinued
NAPROXEN SODIUM EQ 500MG BASE · TABLET · ORAL
NAPROXEN SODIUMDiscontinued
NAPROXEN SODIUM EQ 250MG BASE · TABLET · ORAL
Approval history
2021-03-29Labeling · Supplement 7 · standardAP
2021-03-29Labeling · Supplement 6 · standardAP
1999-03-23Manufacturing (CMC) · Supplement 5AP
1996-10-18Labeling · Supplement 4AP
1996-05-31Manufacturing (CMC) · Supplement 3AP
1996-03-22Labeling · Supplement 2AP
1994-06-28Manufacturing (CMC) · Supplement 1AP
1994-01-27OriginalAP
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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