APPLICATION
ANDA075390
TYPE
ANDA
ORIGINAL APPROVAL
2001-04-19
LATEST ACTION
2020-03-19
ROUTE
ORAL
DOSAGE FORM
TABLET, DELAYED RELEASE
MARKETING STATUS
Prescription
Products
NAPROXENPrescription
NAPROXEN 500MG · TABLET, DELAYED RELEASE · ORAL
NAPROXENPrescription
NAPROXEN 375MG · TABLET, DELAYED RELEASE · ORAL
Approval history
2020-03-19Labeling · Supplement 6 · standardAP
2020-03-19Labeling · Supplement 7 · standardAP
2020-03-19Labeling · Supplement 5 · standardAP
2008-09-23Labeling · Supplement 3AP
2007-09-25Labeling · Supplement 2AP
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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