APPLICATION
ANDA208202
TYPE
ANDA
ORIGINAL APPROVAL
2020-01-10
LATEST ACTION
2024-05-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
VILAZODONE HYDROCHLORIDEPrescription
VILAZODONE HYDROCHLORIDE 20MG · TABLET · ORAL
VILAZODONE HYDROCHLORIDEPrescription
VILAZODONE HYDROCHLORIDE 40MG · TABLET · ORAL
VILAZODONE HYDROCHLORIDEPrescription
VILAZODONE HYDROCHLORIDE 10MG · TABLET · ORAL
Approval history
2024-05-29Labeling · Supplement 10 · standardAP
2024-01-03Labeling · Supplement 8 · standardAP
2023-07-18Labeling · Supplement 4 · standardAP
2023-07-18Manufacturing (CMC) · Supplement 2 · standardAP
2023-07-18Labeling · Supplement 1 · standardAP
2020-01-10UNKNOWN · 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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