APPLICATION
ANDA200429
TYPE
ANDA
ORIGINAL APPROVAL
2011-11-08
LATEST ACTION
2025-03-13
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
2025-03-13Labeling · Supplement 14 · standardAP
2025-03-13Labeling · Supplement 20 · standardAP
2025-03-13Labeling · Supplement 19 · standardAP
2019-10-03Labeling · Supplement 8 · standardAP
2019-10-03Labeling · Supplement 11 · standardAP
2019-10-03Labeling · Supplement 7 · standardAP
2015-06-30Labeling · Supplement 4 · standardAP
2011-11-08Not Applicable · OriginalAP
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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