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FDA ANDA · ANDA091416

NAPROXEN

Sponsor: ADAPTIS

APPLICATION
ANDA091416
TYPE
ANDA
ORIGINAL APPROVAL
2011-02-14
LATEST ACTION
2015-06-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

NAPROXENPrescription
NAPROXEN 375MG · TABLET · ORAL
NAPROXENPrescription
NAPROXEN 500MG · TABLET · ORAL
NAPROXENPrescription
NAPROXEN 250MG · TABLET · ORAL

Approval history

2015-06-29Labeling · Supplement 1 · standardAP
2011-02-14OriginalAP
VIEW ON DRUGS@FDA ↗

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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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