APPLICATION
ANDA076009
TYPE
ANDA
ORIGINAL APPROVAL
2003-01-24
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 15 · standardAP
2021-05-24Labeling · Supplement 14 · standardAP
2016-05-09Labeling · Supplement 13 · standardAP
2006-04-25Labeling · Supplement 8AP
2006-03-02Labeling · Supplement 7AP
2003-01-24OriginalAP
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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