APPLICATION
ANDA206093
TYPE
ANDA
ORIGINAL APPROVAL
2020-03-17
LATEST ACTION
2023-05-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TETRABENAZINEPrescription
TETRABENAZINE 25MG · TABLET · ORAL
TETRABENAZINEPrescription
TETRABENAZINE 12.5MG · TABLET · ORAL
Approval history
2023-05-19Labeling · Supplement 1 · standardAP
2020-03-17UNKNOWN · 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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