APPLICATION
ANDA078250
TYPE
ANDA
ORIGINAL APPROVAL
2007-03-28
LATEST ACTION
2020-07-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
NAPROXENPrescription
NAPROXEN 375MG · TABLET · ORAL
NAPROXENPrescription
NAPROXEN 500MG · TABLET · ORAL
NAPROXENPrescription
NAPROXEN 250MG · TABLET · ORAL
Approval history
2020-07-28Labeling · Supplement 18 · standardAP
2020-07-28Labeling · Supplement 16 · standardAP
2020-07-28Labeling · Supplement 14 · standardAP
2015-04-13Labeling · Supplement 12 · standardAP
2011-04-08Labeling · Supplement 8AP
2008-09-08Labeling · Supplement 2AP
2007-03-28OriginalAP
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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