APPLICATION
ANDA215971
TYPE
ANDA
ORIGINAL APPROVAL
2024-12-26
LATEST ACTION
2026-05-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
DEUTETRABENAZINEDiscontinued
DEUTETRABENAZINE 12MG · TABLET · ORAL
DEUTETRABENAZINEDiscontinued
DEUTETRABENAZINE 6MG · TABLET · ORAL
DEUTETRABENAZINEDiscontinued
DEUTETRABENAZINE 9MG · TABLET · ORAL
Approval history
2026-05-01Labeling · 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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