APPLICATION
ANDA074140
TYPE
ANDA
ORIGINAL APPROVAL
1993-12-21
LATEST ACTION
2022-03-11
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
NAPROXENPrescription
NAPROXEN 375MG · TABLET · ORAL
NAPROXENPrescription
NAPROXEN 500MG · TABLET · ORAL
NAPROXENPrescription
NAPROXEN 250MG · TABLET · ORAL
Approval history
2022-03-11Labeling · Supplement 41 · standardAP
2022-03-11Labeling · Supplement 38 · standardAP
2022-03-11Manufacturing (CMC) · Supplement 42 · standardAP
2022-03-11Labeling · Supplement 40 · standardAP
2022-03-11Labeling · Supplement 37 · standardAP
2008-10-29Labeling · Supplement 31AP
2008-04-29Labeling · Supplement 28AP
2007-11-28Labeling · Supplement 27AP
2007-07-15Labeling · Supplement 26AP
2002-04-19Manufacturing (CMC) · Supplement 19AP
2002-03-25Manufacturing (CMC) · Supplement 20AP
2001-10-22Manufacturing (CMC) · Supplement 18AP
2001-10-05Manufacturing (CMC) · Supplement 17AP
2001-10-05Manufacturing (CMC) · Supplement 16AP
2000-11-13Manufacturing (CMC) · Supplement 15AP
2000-11-13Manufacturing (CMC) · Supplement 13AP
2000-11-13Manufacturing (CMC) · Supplement 11AP
2000-11-13Manufacturing (CMC) · Supplement 12AP
2000-08-17Manufacturing (CMC) · Supplement 7AP
2000-08-17Labeling · Supplement 8AP
1999-05-05Manufacturing (CMC) · Supplement 14AP
1998-08-17Manufacturing (CMC) · Supplement 10AP
1998-07-14Manufacturing (CMC) · Supplement 9AP
1997-10-03Manufacturing (CMC) · Supplement 5AP
1997-05-22Manufacturing (CMC) · Supplement 4AP
1995-12-01Manufacturing (CMC) · Supplement 3AP
1995-01-31Manufacturing (CMC) · Supplement 2AP
1995-01-05Manufacturing (CMC) · Supplement 1AP
1993-12-21OriginalAP
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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