APPLICATION
ANDA212199
TYPE
ANDA
ORIGINAL APPROVAL
2019-10-30
LATEST ACTION
2026-06-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
NAPROXEN SODIUMPrescription
NAPROXEN SODIUM EQ 500MG BASE · TABLET · ORAL
NAPROXEN SODIUMPrescription
NAPROXEN SODIUM EQ 250MG BASE · TABLET · ORAL
Approval history
2026-06-25Labeling · Supplement 3 · standardAP
2026-06-25Labeling · Supplement 12 · standardAP
2019-10-30UNKNOWN · 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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