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FDA ANDA · ANDA074162

NAPROXEN SODIUM

Sponsor: SANDOZ

APPLICATION
ANDA074162
TYPE
ANDA
ORIGINAL APPROVAL
1993-12-21
LATEST ACTION
2002-04-19
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

2002-04-19Manufacturing (CMC) · Supplement 16AP
2001-08-29Manufacturing (CMC) · Supplement 13AP
2001-08-08Manufacturing (CMC) · Supplement 14AP
2001-05-09Manufacturing (CMC) · Supplement 15AP
2001-04-26Manufacturing (CMC) · Supplement 11AP
2001-01-04Manufacturing (CMC) · Supplement 12AP
1999-05-05Manufacturing (CMC) · Supplement 10AP
1999-03-04Labeling · Supplement 7AP
1999-03-04Manufacturing (CMC) · Supplement 6AP
1998-06-29Manufacturing (CMC) · Supplement 9AP
1998-03-09Labeling · Supplement 8AP
1998-02-04Manufacturing (CMC) · Supplement 4AP
1997-11-10Labeling · Supplement 5AP
1997-10-17Manufacturing (CMC) · Supplement 3AP
1997-10-17Manufacturing (CMC) · Supplement 2AP
1996-02-27Manufacturing (CMC) · Supplement 1AP
1993-12-21OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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