Zeposia

NDA 209899, held by Bristol. Ozanimod Hydrochloride.

As of Nov 13, 2026, NDA 209899 (Zeposia), held by Bristol, was first approved by FDA on Mar 25, 2020, with 9 approved supplements and 0 published complete response letters.

First approved: Mar 25, 2020
Review: Standard
Supplements approved: 9
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

ZEPOSIA is indicated for the treatment of: relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. moderately to severely active ulcerative colitis (UC) in adults. ZEPOSIA is a sphingosine 1-phosphate receptor modulator indicated for the treatment of: Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Moderately to severely active ulcerative colitis (UC) in adults.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 10 submissions below


Aug 30, 2024	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Label Letter
May 27, 2021	Supplement 1Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Mar 25, 2020	Original applicationNew molecular entity · Standard review	Approved	Review Label Letter

Products

3 strengths and forms


ZeposiaEQ 0.23MG BASE · capsule;oral	Ozanimod Hydrochloride	RxReference drug
ZeposiaEQ 0.46MG BASE · capsule;oral	Ozanimod Hydrochloride	RxReference drug
ZeposiaEQ 0.92MG BASE · capsule;oral	Ozanimod Hydrochloride	RxReference drug

All 10 submissions, including labeling and manufacturing supplements


Aug 30, 2024	Supplement 11Efficacy (new indication or use) · Standard review	Approved	Label Letter
Aug 30, 2024	Supplement 12Labeling · Standard review	Approved	Label Letter
Jun 5, 2024	Supplement 13Labeling · Standard review	Approved	Letter Label
Jun 5, 2024	Supplement 14Labeling · Standard review	Approved	Letter Label Medication Guide
Aug 10, 2023	Supplement 6Labeling · Standard review	Approved	Label
Aug 10, 2023	Supplement 9Labeling · Standard review	Approved	Label Medication Guide
Sep 29, 2022	Supplement 5Labeling · Standard review	Approved	Label Medication Guide Letter
Dec 15, 2021	Supplement 3Labeling · Standard review	Approved	Letter Label
May 27, 2021	Supplement 1Efficacy (new indication or use) · Priority review	Approved	Review Letter Label
Mar 25, 2020	Original applicationNew molecular entity · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 209899
Drugs@FDA: Overview at FDA
Company: Bristol Laboratories

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters