APPLICATION
ANDA208212
TYPE
ANDA
ORIGINAL APPROVAL
2019-09-30
LATEST ACTION
2025-01-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
VILAZODONE HYDROCHLORIDEPrescription
VILAZODONE HYDROCHLORIDE 40MG · TABLET · ORAL
VILAZODONE HYDROCHLORIDEPrescription
VILAZODONE HYDROCHLORIDE 10MG · TABLET · ORAL
VILAZODONE HYDROCHLORIDEPrescription
VILAZODONE HYDROCHLORIDE 20MG · TABLET · ORAL
Approval history
2025-01-14Labeling · Supplement 8 · standardAP
2023-06-07Labeling · Supplement 3 · standardAP
2019-09-30UNKNOWN · 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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