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FDA NDA · NDA213498

PONVORY

ponesimod

Sponsor: VANDA PHARMS INC

APPLICATION
NDA213498
TYPE
NDA
ORIGINAL APPROVAL
2021-03-18
LATEST ACTION
2024-06-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

PONVORY · ReferencePrescription
PONESIMOD 9MG · TABLET · ORAL
PONVORY · ReferencePrescription
PONESIMOD 7MG · TABLET · ORAL
PONVORY · ReferencePrescription
PONESIMOD 5MG · TABLET · ORAL
PONVORY · ReferencePrescription
PONESIMOD 20MG · TABLET · ORAL
PONVORY · ReferencePrescription
PONESIMOD 3MG · TABLET · ORAL
PONVORY · ReferencePrescription
PONESIMOD 10MG · TABLET · ORAL
PONVORY · ReferencePrescription
PONESIMOD 8MG · TABLET · ORAL
PONVORY · ReferencePrescription
PONESIMOD 6MG · TABLET · ORAL
PONVORY · ReferencePrescription
PONESIMOD 4MG · TABLET · ORAL
PONVORY · ReferencePrescription
PONESIMOD 2MG · TABLET · ORAL

Approval history

2024-06-05Labeling · Supplement 6 · standard — Label ↗AP
2024-06-05Labeling · Supplement 5 · standard — Label ↗AP
2023-08-10Labeling · Supplement 4 · standard — Letter ↗AP
2021-10-28Labeling · Supplement 1 · standard — Label ↗AP
2021-03-18Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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