← FDA DRUG APPROVALS

FDA NDA · NDA020067

NAPROXEN

Sponsor: ATNAHS PHARMA US

APPLICATION
NDA020067
TYPE
NDA
ORIGINAL APPROVAL
1994-10-14
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription

Products

EC-NAPROSYN · ReferencePrescription
NAPROXEN 500MG · TABLET, DELAYED RELEASE · ORAL
EC-NAPROSYN · ReferencePrescription
NAPROXEN 375MG · TABLET, DELAYED RELEASE · ORAL

Approval history

2024-11-21Labeling · Supplement 26 · standard — Label ↗AP
2024-05-13Labeling · Supplement 25 · standard — Letter ↗AP
2021-04-28Labeling · Supplement 24 · standard — Letter ↗AP
2019-07-22Labeling · Supplement 21 · standard — Letter ↗AP
2017-03-10Labeling · Supplement 20 · standard — Label ↗AP
2016-05-09Labeling · Supplement 19 · standard — Letter ↗AP
2013-03-22Labeling · Supplement 18 · standard — Label ↗AP
2008-07-25Labeling · Supplement 17 · standard — Label ↗AP
2007-09-20Labeling · Supplement 14 · standard — Label ↗AP
2007-04-19Labeling · Supplement 13 · standard — Letter ↗AP
2006-03-10Labeling · Supplement 10 · standard — Letter ↗AP
2006-01-24Labeling · Supplement 11 · standard — Label ↗AP
2004-11-10Labeling · Supplement 6 · standard — Letter ↗AP
2004-11-10Labeling · Supplement 4 · standard — Label ↗AP
2003-05-19Labeling · Supplement 5 · standard — Letter ↗AP
2002-02-22Manufacturing (CMC) · Supplement 9 · standardAP
2001-11-09Manufacturing (CMC) · Supplement 8 · standardAP
1997-07-09Manufacturing (CMC) · Supplement 3 · standardAP
1996-06-28Manufacturing (CMC) · Supplement 2 · standardAP
1994-12-06Manufacturing (CMC) · Supplement 1 · standardAP
1994-10-14Type 3 - New Dosage Form · Original · standardAP
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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