← FDA DRUG APPROVALS

FDA NDA · NDA209899

ZEPOSIA 7-DAY STARTER PACK

ozanimod hydrochloride

Sponsor: BRISTOL

APPLICATION
NDA209899
TYPE
NDA
ORIGINAL APPROVAL
2020-03-25
LATEST ACTION
2024-08-30
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

ZEPOSIA · ReferencePrescription
OZANIMOD HYDROCHLORIDE EQ 0.23MG BASE · CAPSULE · ORAL
ZEPOSIA · ReferencePrescription
OZANIMOD HYDROCHLORIDE EQ 0.46MG BASE · CAPSULE · ORAL
ZEPOSIA · ReferencePrescription
OZANIMOD HYDROCHLORIDE EQ 0.92MG BASE · CAPSULE · ORAL

Approval history

2024-08-30Efficacy · Supplement 11 · standard — Label ↗AP
2024-08-30Labeling · Supplement 12 · standard — Label ↗AP
2024-06-05Labeling · Supplement 13 · standard — Letter ↗AP
2024-06-05Labeling · Supplement 14 · standard — Label ↗AP
2023-08-10Labeling · Supplement 6 · standard — Label ↗AP
2023-08-10Labeling · Supplement 9 · standard — Label ↗AP
2022-09-29Labeling · Supplement 5 · standard — Letter ↗AP
2021-12-15Labeling · Supplement 3 · standard — Label ↗AP
2021-05-27Efficacy · Supplement 1 · priority — Label ↗AP
2020-03-25Type 1 - New Molecular Entity · Original · standard — Label ↗AP
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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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