← FDA DRUG APPROVALS

FDA NDA · NDA017581

NAPROSYN

Sponsor: ATNAHS PHARMA US

APPLICATION
NDA017581
TYPE
NDA
ORIGINAL APPROVAL
1976-03-11
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued

Products

NAPROSYN · ReferencePrescription
NAPROXEN 500MG · TABLET · ORAL
NAPROSYN · ReferenceDiscontinued
NAPROXEN 250MG · TABLET · ORAL
NAPROSYN · ReferenceDiscontinued
NAPROXEN 375MG · TABLET · ORAL

Approval history

2024-11-21Labeling · Supplement 117 · standard — Label ↗AP
2024-05-13Labeling · Supplement 116 · standard — Label ↗AP
2021-04-28Labeling · Supplement 115 · standard — Label ↗AP
2019-07-22Labeling · Supplement 114 · standard — Letter ↗AP
2017-03-10Labeling · Supplement 113 · standard — Label ↗AP
2016-05-09Labeling · Supplement 112 · standard — Letter ↗AP
2013-03-22Labeling · Supplement 111 · standard — Letter ↗AP
2008-07-25Labeling · Supplement 110 · standard — Label ↗AP
2007-09-20Labeling · Supplement 108 · standard — Letter ↗AP
2007-04-19Labeling · Supplement 107 · standard — Letter ↗AP
2006-03-10Labeling · Supplement 105 · standard — Label ↗AP
2006-01-24Labeling · Supplement 106 · standard — Label ↗AP
2004-11-10Labeling · Supplement 100 · standard — Letter ↗AP
2004-11-10Labeling · Supplement 99 · standard — Letter ↗AP
2003-04-14Labeling · Supplement 98 · standard — Letter ↗AP
2002-02-22Manufacturing (CMC) · Supplement 103 · standardAP
2001-11-09Manufacturing (CMC) · Supplement 102 · standardAP
2000-12-08Manufacturing (CMC) · Supplement 101 · standardAP
1994-12-08Manufacturing (CMC) · Supplement 97 · standardAP
1994-09-12Manufacturing (CMC) · Supplement 95 · standardAP
1994-04-21Manufacturing (CMC) · Supplement 87 · standardAP
1994-03-28Manufacturing (CMC) · Supplement 96 · standardAP
1992-08-12Manufacturing (CMC) · Supplement 93 · standardAP
1992-05-08Manufacturing (CMC) · Supplement 89 · standardAP
1991-10-30Manufacturing (CMC) · Supplement 86 · standardAP
1991-09-16Manufacturing (CMC) · Supplement 88 · standardAP
1989-04-21Manufacturing (CMC) · Supplement 80 · standardAP
1988-02-18Manufacturing (CMC) · Supplement 51 · standardAP
1987-03-23Efficacy · Supplement 73AP
1987-03-23Efficacy · Supplement 65AP
1986-12-16Manufacturing (CMC) · Supplement 63 · standardAP
1986-12-16Labeling · Supplement 72AP
1986-07-17Manufacturing (CMC) · Supplement 67 · standardAP
1986-06-10Manufacturing (CMC) · Supplement 68 · standardAP
1985-09-24Labeling · Supplement 69AP
1985-04-29Manufacturing (CMC) · Supplement 60 · standardAP
1985-04-23Manufacturing (CMC) · Supplement 53 · standardAP
1985-04-23Manufacturing (CMC) · Supplement 64 · standardAP
1985-04-23Manufacturing (CMC) · Supplement 62 · standardAP
1983-09-09Labeling · Supplement 54AP
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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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