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FDA NDA · NDA020353

NAPROXEN SODIUM

Sponsor: TWI PHARMS

APPLICATION
NDA020353
TYPE
NDA
ORIGINAL APPROVAL
1996-01-05
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

NAPRELAN · ReferencePrescription
NAPROXEN SODIUM EQ 500MG BASE · TABLET, EXTENDED RELEASE · ORAL
NAPRELAN · ReferencePrescription
NAPROXEN SODIUM EQ 750MG BASE · TABLET, EXTENDED RELEASE · ORAL
NAPRELAN · ReferencePrescription
NAPROXEN SODIUM EQ 375MG BASE · TABLET, EXTENDED RELEASE · ORAL

Approval history

2024-11-21Labeling · Supplement 41 · standard — Label ↗AP
2021-04-28Labeling · Supplement 38 · standard — Letter ↗AP
2019-07-22Labeling · Supplement 36 · standard — Letter ↗AP
2017-09-06Manufacturing (CMC) · Supplement 34 — Label ↗AP
2016-05-09Labeling · Supplement 32 · standard — Label ↗AP
2016-05-09Labeling · Supplement 31 · standard — Letter ↗AP
2014-09-12Manufacturing (CMC) · Supplement 30 · standardAP
2011-11-08Labeling · Supplement 28 · standard — Letter ↗AP
2009-07-08Manufacturing (CMC) · Supplement 23 — Letter ↗AP
2007-05-29Labeling · Supplement 19 · standard — Letter ↗AP
2006-01-18Labeling · Supplement 16 · standard — Letter ↗AP
2002-04-15Manufacturing (CMC) · Supplement 14 · standardAP
2002-02-04Labeling · Supplement 8 · standardAP
2001-10-02Manufacturing (CMC) · Supplement 13 · standardAP
2001-06-04Manufacturing (CMC) · Supplement 12 · standardAP
2000-06-15Manufacturing (CMC) · Supplement 11 · standardAP
2000-02-15Manufacturing (CMC) · Supplement 10 · standardAP
1999-11-02Manufacturing (CMC) · Supplement 7 · standardAP
1999-07-20Manufacturing (CMC) · Supplement 9 · standardAP
1997-12-23Manufacturing (CMC) · Supplement 6 · standardAP
1997-05-12Manufacturing (CMC) · Supplement 5 · standardAP
1997-01-31Manufacturing (CMC) · Supplement 3 · standardAP
1997-01-31Manufacturing (CMC) · Supplement 4 · standardAP
1996-03-28Labeling · Supplement 1 · standard — Review ↗AP
1996-01-05Type 3 - New Dosage Form · Original · standard — Medication Guide ↗AP
VIEW ON DRUGS@FDA ↗

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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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