← FDA DRUG APPROVALS

FDA NDA · NDA018164

ANAPROX DS

Sponsor: ATNAHS PHARMA US

APPLICATION
NDA018164
TYPE
NDA
ORIGINAL APPROVAL
1980-09-04
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued

Products

ANAPROX DS · ReferencePrescription
NAPROXEN SODIUM EQ 500MG BASE · TABLET · ORAL
ANAPROX · ReferenceDiscontinued
NAPROXEN SODIUM EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2024-11-21Labeling · Supplement 67 · standard — Label ↗AP
2024-05-13Labeling · Supplement 66 · standard — Label ↗AP
2021-04-28Labeling · Supplement 65 · standard — Letter ↗AP
2019-07-22Labeling · Supplement 64 · standard — Letter ↗AP
2017-03-10Labeling · Supplement 63 · standard — Label ↗AP
2016-05-09Labeling · Supplement 62 · standard — Label ↗AP
2013-03-22Labeling · Supplement 61 · standard — Label ↗AP
2008-07-25Labeling · Supplement 60 · standard — Label ↗AP
2007-09-20Labeling · Supplement 58 · standard — Letter ↗AP
2007-04-19Labeling · Supplement 57 · standard — Letter ↗AP
2006-03-10Labeling · Supplement 55 · standard — Letter ↗AP
2006-01-24Labeling · Supplement 56 · standard — Letter ↗AP
2004-11-10Labeling · Supplement 51 · standard — Letter ↗AP
2004-11-10Labeling · Supplement 50 · standard — Letter ↗AP
2003-04-14Labeling · Supplement 49 · standard — Letter ↗AP
2002-02-22Manufacturing (CMC) · Supplement 54 · standardAP
2001-11-09Manufacturing (CMC) · Supplement 53 · standardAP
2000-12-08Manufacturing (CMC) · Supplement 52 · standardAP
1995-02-08Manufacturing (CMC) · Supplement 47 · standardAP
1994-09-06Manufacturing (CMC) · Supplement 48 · standardAP
1993-12-15Labeling · Supplement 46 · standardAP
1992-08-12Manufacturing (CMC) · Supplement 45 · standardAP
1992-05-08Manufacturing (CMC) · Supplement 43 · standardAP
1990-10-02Manufacturing (CMC) · Supplement 42 · standardAP
1987-09-30Efficacy · Supplement 35AP
1987-09-30Labeling · Supplement 15AP
1987-09-30Efficacy · Supplement 36AP
1987-09-30Labeling · Supplement 34AP
1987-09-30Manufacturing (CMC) · Supplement 26 · standardAP
1986-08-29Manufacturing (CMC) · Supplement 20 · standardAP
1986-06-10Manufacturing (CMC) · Supplement 33 · standardAP
1985-09-24Labeling · Supplement 31AP
1985-05-03Manufacturing (CMC) · Supplement 28 · standardAP
1985-04-29Manufacturing (CMC) · Supplement 25 · standardAP
1985-04-23Manufacturing (CMC) · Supplement 14 · standardAP
1983-09-09Labeling · Supplement 12AP
1983-09-09Labeling · Supplement 21AP
1983-02-22Manufacturing (CMC) · Supplement 18 · standardAP
1982-12-07Labeling · Supplement 16AP
1982-12-07Labeling · Supplement 17AP
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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