APPLICATION
ANDA212517
TYPE
ANDA
ORIGINAL APPROVAL
2020-02-21
LATEST ACTION
2025-08-28
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
2025-08-28Labeling · Supplement 15 · standardAP
2023-03-02Labeling · Supplement 4 · standardAP
2020-02-21UNKNOWN · Original · standardAP
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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