APPLICATION
ANDA078620
TYPE
ANDA
ORIGINAL APPROVAL
2007-06-07
LATEST ACTION
2025-06-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
NAPROXENPrescription
NAPROXEN 500MG · TABLET · ORAL
NAPROXENPrescription
NAPROXEN 250MG · TABLET · ORAL
NAPROXENPrescription
NAPROXEN 375MG · TABLET · ORAL
Approval history
2025-06-13Labeling · Supplement 5 · standardAP
2025-06-13Labeling · Supplement 3 · standardAP
2025-06-13Labeling · Supplement 4 · standardAP
2025-06-13Labeling · Supplement 2 · standardAP
2008-08-22Labeling · Supplement 1AP
2007-06-07OriginalAP
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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