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ZEPOSIA

ozanimod hydrochloride · Kit

Prescription NDA RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information.

Overview

Brand name
ZEPOSIA Starter Kit
Generic name
ozanimod hydrochloride
Dosage form
Kit
Route
—
Marketing category
NDA · NDA
Labeler
Celgene Corporation
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
0
NDC product codes
2
Packages
4
Data completeness
54% of corroborating sources present

Forms, strengths and routes

Source: NDC Directory
Dosage form
Kit
Route of administration
—
Presentations
6

Regulatory status

Source: Drugs@FDANDC Directory
Application number
209899
Application type
NDA · New Drug Application
Approval date
March 25, 2020
Sponsor
BRISTOL
Products on application
3
Submissions recorded
10
Products approved under application 209899.
Product Trade name Form Strength Ingredient Status TE Flags
209899-001 ZEPOSIA CAPSULE OZANIMOD HYDROCHLORIDE Prescription — RLD
209899-002 ZEPOSIA CAPSULE OZANIMOD HYDROCHLORIDE Prescription — RLD
209899-003 ZEPOSIA CAPSULE OZANIMOD HYDROCHLORIDE Prescription — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
9382217 May 14, 2029 001 No U-2774 April 16, 2020
8796318 May 14, 2029 001 Yes April 16, 2020
9382217 May 14, 2029 002 No U-2774 April 16, 2020
8796318 May 14, 2029 002 Yes April 16, 2020
9382217 May 14, 2029 003 No U-2774 April 16, 2020
8796318 May 14, 2029 003 Yes April 16, 2020
10239846 November 15, 2030 001 No U-3740 June 22, 2021
10239846 November 15, 2030 002 No U-3740 June 22, 2021
10239846 November 15, 2030 003 No U-3740 June 22, 2021
8481573 March 24, 2033 001 Yes U-2774 April 16, 2020
8481573 March 24, 2033 002 Yes U-2774 April 16, 2020
8481573 March 24, 2033 003 Yes U-2774 April 16, 2020
11680050 September 30, 2038 001 Yes U-2774 November 16, 2023
11680050 September 30, 2038 001 Yes U-3740 November 16, 2023
11680050 September 30, 2038 002 Yes U-2774 November 16, 2023
11680050 September 30, 2038 002 Yes U-3740 November 16, 2023
11680050 September 30, 2038 003 Yes U-2774 November 16, 2023
11680050 September 30, 2038 003 Yes U-3740 November 16, 2023
Regulatory exclusivity periods.
Code Expires Product
M-309 August 30, 2027 001
M-309 August 30, 2027 002
M-309 August 30, 2027 003

Approval history

Source: Drugs@FDA
Most recent submissions on application 209899.
Type No. Action Status Date Review
Supplement 12 Labeling Approved August 30, 2024 Standard
Supplement 11 Efficacy Approved August 30, 2024 Standard
Supplement 14 Labeling Approved June 5, 2024 Standard
Supplement 13 Labeling Approved June 5, 2024 Standard
Supplement 9 Labeling Approved August 10, 2023 Standard
Supplement 6 Labeling Approved August 10, 2023 Standard
Supplement 5 Labeling Approved September 29, 2022 Standard
Supplement 3 Labeling Approved December 15, 2021 Standard
Supplement 1 Efficacy Approved May 27, 2021 Priority
Original application 1 Type 1 - New Molecular Entity Approved March 25, 2020 Standard

Review documents

  • 0 · Supplement · September 3, 2024
  • 0 · Supplement · September 3, 2024
  • 0 · Supplement · September 3, 2024
  • 0 · Supplement · September 3, 2024
  • 0 · Supplement · July 2, 2024
  • 0 · Supplement · July 2, 2024
  • 0 · Supplement · June 7, 2024
  • 0 · Supplement · June 6, 2024
  • 0 · Supplement · June 6, 2024
  • 0 · Supplement · October 2, 2023
  • 0 · Supplement · August 14, 2023
  • 0 · Supplement · August 14, 2023
  • 0 · Supplement · August 14, 2023
  • 0 · Supplement · October 3, 2022
  • 0 · Supplement · October 3, 2022
  • 0 · Supplement · September 30, 2022
  • 0 · Supplement · December 21, 2021
  • 0 · Supplement · December 17, 2021
  • 0 · Supplement · June 1, 2021
  • 0 · Supplement · May 28, 2021
  • 0 · Original application · April 23, 2020
  • 0 · Original application · March 26, 2020
  • 0 · Original application · March 26, 2020

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
59572-810-07 59572-810 Celgene Corporation 1 KIT in 1 BLISTER PACK (59572-810-07) * 1 CAPSULE in 1 BLISTER PACK * 1 CAPSULE in 1 BLISTER PACK March 27, 2020
59572-810-97 59572-810 Celgene Corporation 1 KIT in 1 BLISTER PACK (59572-810-97) * 1 CAPSULE in 1 BLISTER PACK * 1 CAPSULE in 1 BLISTER PACK March 27, 2020
59572-890-28 59572-890 Celgene Corporation 1 KIT in 1 CARTON (59572-890-28) * 1 CAPSULE in 1 BLISTER PACK * 21 CAPSULE in 1 BOTTLE, PLASTIC * 1 CAPSULE in 1 BLISTER PACK June 20, 2023
59572-890-98 59572-890 Celgene Corporation 1 KIT in 1 CARTON (59572-890-98) * 1 CAPSULE in 1 BLISTER PACK * 21 CAPSULE in 1 BOTTLE, PLASTIC * 1 CAPSULE in 1 BLISTER PACK June 20, 2023
59572-810 59572-810 Celgene Corporation — March 27, 2020
59572-890 59572-890 Celgene Corporation — March 27, 2020

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity

Generated September 25, 2026 · 8 sections on this page.