APPLICATION
ANDA203166
TYPE
ANDA
ORIGINAL APPROVAL
2019-08-30
LATEST ACTION
2024-11-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
NABUMETONEPrescription
NABUMETONE 750MG · TABLET · ORAL
NABUMETONEPrescription
NABUMETONE 1GM · TABLET · ORAL
NABUMETONEPrescription
NABUMETONE 500MG · TABLET · ORAL
Approval history
2024-11-22Labeling · Supplement 5 · standardAP
2021-04-28Labeling · Supplement 3 · standardAP
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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