APPLICATION
ANDA091083
TYPE
ANDA
ORIGINAL APPROVAL
2011-06-13
LATEST ACTION
2024-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
NABUMETONEPrescription
NABUMETONE 500MG · TABLET · ORAL
NABUMETONEPrescription
NABUMETONE 750MG · TABLET · ORAL
Approval history
2024-11-21Labeling · Supplement 17 · standardAP
2024-06-24Labeling · Supplement 12 · standardAP
2021-04-28Labeling · Supplement 11 · standardAP
2016-05-09Labeling · Supplement 9 · standardAP
2011-06-13OriginalAP
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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