APPLICATION
ANDA206129
TYPE
ANDA
ORIGINAL APPROVAL
2015-08-17
LATEST ACTION
2025-05-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
TETRABENAZINEDiscontinued
TETRABENAZINE 12.5MG · TABLET · ORAL
TETRABENAZINEDiscontinued
TETRABENAZINE 25MG · TABLET · ORAL
Approval history
2025-05-18Labeling · Supplement 7 · standardAP
2021-01-04Labeling · Supplement 1 · 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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