APPLICATION
ANDA075416
TYPE
ANDA
ORIGINAL APPROVAL
2002-08-27
LATEST ACTION
2024-08-22
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
NAPROXEN SODIUMPrescription
NAPROXEN SODIUM EQ 750MG BASE · TABLET, EXTENDED RELEASE · ORAL
NAPROXEN SODIUMPrescription
NAPROXEN SODIUM EQ 500MG BASE · TABLET, EXTENDED RELEASE · ORAL
NAPROXEN SODIUMPrescription
NAPROXEN SODIUM EQ 375MG BASE · TABLET, EXTENDED RELEASE · ORAL
Approval history
2024-08-22Labeling · Supplement 20 · standardAP
2019-11-25Labeling · Supplement 19 · standardAP
2016-09-08Labeling · Supplement 16 · standardAP
2015-04-15Labeling · Supplement 12 · standardAP
2008-02-21Labeling · Supplement 8AP
2007-04-03Labeling · Supplement 6AP
2003-04-23Manufacturing (CMC) · Supplement 3AP
2003-04-23Labeling · Supplement 2AP
2003-03-21Manufacturing (CMC) · Supplement 1AP
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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