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FDA ANDA · ANDA090545

NAPROXEN SODIUM 220MG

Sponsor: MARKSANS PHARMA

APPLICATION
ANDA090545
TYPE
ANDA
ORIGINAL APPROVAL
2011-03-16
LATEST ACTION
2023-07-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter

Products

NAPROXEN SODIUMOver-the-counter
NAPROXEN SODIUM 220MG · TABLET · ORAL

Approval history

2023-07-21Labeling · Supplement 1 · standardAP
2023-07-21Labeling · Supplement 4 · standardAP
2023-07-21Labeling · Supplement 2 · standardAP
2011-03-16OriginalAP
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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