APPLICATION
ANDA215776
TYPE
ANDA
ORIGINAL APPROVAL
2022-06-07
LATEST ACTION
2026-06-30
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Prescription
Products
NAPROXENPrescription
NAPROXEN 25MG/ML · SUSPENSION · ORAL
Approval history
2026-06-30Labeling · Supplement 3 · standardAP
2022-12-21Labeling · Supplement 1 · standardAP
2022-06-07UNKNOWN · 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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