← FDA DRUG APPROVALS

FDA NDA · NDA018965

NAPROXEN

Sponsor: ATNAHS PHARMA US

APPLICATION
NDA018965
TYPE
NDA
ORIGINAL APPROVAL
1987-03-23
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription

Products

NAPROSYN · ReferencePrescription
NAPROXEN 25MG/ML · SUSPENSION · ORAL

Approval history

2024-11-21Labeling · Supplement 28 · standard — Label ↗AP
2021-04-28Labeling · Supplement 27 · standard — Letter ↗AP
2019-07-22Labeling · Supplement 26 · standard — Letter ↗AP
2017-03-10Labeling · Supplement 25 · standard — Label ↗AP
2016-05-09Manufacturing (CMC) · Supplement 24 · priorityAP
2016-05-09Labeling · Supplement 22 · standard — Label ↗AP
2016-05-09Labeling · Supplement 23 · standard — Letter ↗AP
2015-07-30Manufacturing (CMC) · Supplement 21 · priorityAP
2013-03-22Labeling · Supplement 20 · standard — Label ↗AP
2008-07-25Labeling · Supplement 18 · standard — Label ↗AP
2007-09-20Labeling · Supplement 16 · standard — Letter ↗AP
2007-04-19Labeling · Supplement 15 · standard — Letter ↗AP
2006-03-10Labeling · Supplement 13 · standard — Label ↗AP
2006-01-24Labeling · Supplement 14 · standard — Label ↗AP
2004-11-10Labeling · Supplement 9 · standard — Label ↗AP
2004-11-10Labeling · Supplement 10 · standard — Letter ↗AP
2003-04-14Labeling · Supplement 7 · standard — Letter ↗AP
2002-02-22Manufacturing (CMC) · Supplement 12 · priorityAP
2001-01-05Manufacturing (CMC) · Supplement 11 · priorityAP
1996-11-14Manufacturing (CMC) · Supplement 8 · priorityAP
1994-09-12Manufacturing (CMC) · Supplement 6 · priorityAP
1993-01-27Manufacturing (CMC) · Supplement 4 · priorityAP
1987-03-23Type 3 - New Dosage Form · Original · priorityAP
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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