APPLICATION
ANDA207466
TYPE
ANDA
ORIGINAL APPROVAL
2017-08-31
LATEST ACTION
2025-03-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
METAXALONEPrescription
METAXALONE 800MG · TABLET · ORAL
METAXALONEPrescription
METAXALONE 400MG · TABLET · ORAL
Approval history
2025-03-21Labeling · Supplement 17 · standardAP
2019-09-27Labeling · Supplement 5 · standardAP
2017-08-31UNKNOWN · Original · 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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