APPLICATION
ANDA075927
TYPE
ANDA
ORIGINAL APPROVAL
2001-12-18
LATEST ACTION
2025-03-13
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
2025-03-13Labeling · Supplement 43 · standardAP
2025-03-13Labeling · Supplement 35 · standardAP
2025-03-13Labeling · Supplement 38 · standardAP
2025-03-13Labeling · Supplement 42 · standardAP
2019-11-22Labeling · Supplement 27 · standardAP
2019-11-22Labeling · Supplement 25 · standardAP
2019-11-22Labeling · Supplement 31 · standardAP
2014-11-02Labeling · Supplement 21 · standardAP
2007-10-16Labeling · Supplement 11AP
2006-05-19Labeling · Supplement 6AP
2002-11-20Manufacturing (CMC) · Supplement 1AP
2001-12-18OriginalAP
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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