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FDA ANDA · ANDA079096

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naproxen sodium

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APPLICATION
ANDA079096
TYPE
ANDA
ORIGINAL APPROVAL
2008-12-16
LATEST ACTION
2015-02-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter

Products

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

Approval history

2015-02-24Manufacturing (CMC) · Supplement 2AP
2015-02-24Labeling · Supplement 8 · standardAP
2014-08-11Labeling · Supplement 9 · standardAP
2011-01-31Labeling · Supplement 4AP
2008-12-16Original — Other Important Information from FDA ↗AP
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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