APPLICATION
ANDA210544
TYPE
ANDA
ORIGINAL APPROVAL
2018-04-20
LATEST ACTION
2018-04-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TETRABENAZINEPrescription
TETRABENAZINE 25MG · TABLET · ORAL
TETRABENAZINEPrescription
TETRABENAZINE 12.5MG · TABLET · ORAL
Approval history
2018-04-20UNKNOWN · 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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