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FDA ANDA · ANDA078314

NAPROXEN SODIUM

Sponsor: GLENMARK PHARMS LTD

APPLICATION
ANDA078314
TYPE
ANDA
ORIGINAL APPROVAL
2007-04-27
LATEST ACTION
2020-07-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

NAPROXEN SODIUMPrescription
NAPROXEN SODIUM EQ 250MG BASE · TABLET · ORAL
NAPROXEN SODIUMPrescription
NAPROXEN SODIUM EQ 500MG BASE · TABLET · ORAL

Approval history

2020-07-28Labeling · Supplement 8 · standardAP
2020-07-28Labeling · Supplement 6 · standardAP
2020-07-28Labeling · Supplement 12 · standardAP
2015-03-02Labeling · Supplement 5 · standardAP
2008-09-08Labeling · Supplement 2AP
2007-04-27Original — Other Important Information from FDA ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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