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FDA NDA · NDA209884

MAYZENT

siponimod

Sponsor: NOVARTIS

APPLICATION
NDA209884
TYPE
NDA
ORIGINAL APPROVAL
2019-03-26
LATEST ACTION
2026-06-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

MAYZENT · ReferencePrescription
SIPONIMOD EQ 1MG BASE · TABLET · ORAL
MAYZENT · ReferencePrescription
SIPONIMOD EQ 0.25MG BASE · TABLET · ORAL
MAYZENT · ReferencePrescription
SIPONIMOD EQ 2MG BASE · TABLET · ORAL

Approval history

2026-06-30Labeling · Supplement 21 · standard — Letter ↗AP
2025-08-21Labeling · Supplement 20 · standard — Letter ↗AP
2024-06-05Labeling · Supplement 19 · standard — Label ↗AP
2023-08-10Labeling · Supplement 18 · standard — Label ↗AP
2023-08-10Labeling · Supplement 16 · standard — Letter ↗AP
2023-01-31Labeling · Supplement 15 · standard — Letter ↗AP
2022-06-21Labeling · Supplement 11 · standard — Letter ↗AP
2022-06-10Labeling · Supplement 10 · standard — Letter ↗AP
2022-03-01Efficacy · Supplement 7 · standard — Letter ↗AP
2021-09-10Labeling · Supplement 5 · standard — Letter ↗AP
2021-08-24Supplement · Supplement 6 · standard — Letter ↗AP
2021-01-23Labeling · Supplement 3 · standard — Letter ↗AP
2020-07-31Labeling · Supplement 2 · standard — Letter ↗AP
2019-03-26Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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