Home Applications 209899 Application 209899
Type NDA
Sponsor CELGENE INTL Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ZEPOSIA OZANIMOD HYDROCHLORIDE CAPSULE;ORAL 0.23MG Yes No 002 ZEPOSIA OZANIMOD HYDROCHLORIDE CAPSULE;ORAL 0.46MG Yes No 003 ZEPOSIA OZANIMOD HYDROCHLORIDE CAPSULE;ORAL 0.92MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N209899-001 ZEPOSIA OZANIMOD HYDROCHLORIDE EQ 0.23MG BASE CAPSULE / ORAL RLD 2020-03-25 N209899-002 ZEPOSIA OZANIMOD HYDROCHLORIDE EQ 0.46MG BASE CAPSULE / ORAL RLD 2020-03-25 N209899-003 ZEPOSIA OZANIMOD HYDROCHLORIDE EQ 0.92MG BASE CAPSULE / ORAL RLD, RS 2020-03-25
Orange Book patents# Current patent rows page 1 of 1 · 18 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N209899-001 8796318 2029-05-14 Drug substance, Drug product 2020-04-16 N209899-001 9382217 2029-05-14 U-2774 2020-04-16 N209899-001 10239846 2030-11-15 U-3740 2021-06-22 N209899-001 8481573 2033-03-24 U-2774 Drug substance, Drug product 2020-04-16 N209899-001 11680050 2038-09-30 U-2774 Drug substance, Drug product 2023-11-16 N209899-001 11680050 2038-09-30 U-3740 Drug substance, Drug product 2023-11-16 N209899-002 8796318 2029-05-14 Drug substance, Drug product 2020-04-16 N209899-002 9382217 2029-05-14 U-2774 2020-04-16 N209899-002 10239846 2030-11-15 U-3740 2021-06-22 N209899-002 8481573 2033-03-24 U-2774 Drug substance, Drug product 2020-04-16 N209899-002 11680050 2038-09-30 U-2774 Drug substance, Drug product 2023-11-16 N209899-002 11680050 2038-09-30 U-3740 Drug substance, Drug product 2023-11-16 N209899-003 8796318 2029-05-14 Drug substance, Drug product 2020-04-16 N209899-003 9382217 2029-05-14 U-2774 2020-04-16 N209899-003 10239846 2030-11-15 U-3740 2021-06-22 N209899-003 8481573 2033-03-24 U-2774 Drug substance, Drug product 2020-04-16 N209899-003 11680050 2038-09-30 U-2774 Drug substance, Drug product 2023-11-16 N209899-003 11680050 2038-09-30 U-3740 Drug substance, Drug product 2023-11-16
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N209899-001 M-309 2027-08-30 N209899-002 M-309 2027-08-30 N209899-003 M-309 2027-08-30
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 111 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N209899-001 ZEPOSIA EQ 0.23MG BASE CAPSULE / ORAL RLD 2020-03-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209899-002 ZEPOSIA EQ 0.46MG BASE CAPSULE / ORAL RLD 2020-03-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209899-003 ZEPOSIA EQ 0.92MG BASE CAPSULE / ORAL RLD, RS 2020-03-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209899-001 ZEPOSIA EQ 0.23MG BASE CAPSULE / ORAL RLD 2020-03-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209899-002 ZEPOSIA EQ 0.46MG BASE CAPSULE / ORAL RLD 2020-03-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209899-003 ZEPOSIA EQ 0.92MG BASE CAPSULE / ORAL RLD, RS 2020-03-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209899-001 ZEPOSIA EQ 0.23MG BASE CAPSULE / ORAL RLD 2020-03-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209899-002 ZEPOSIA EQ 0.46MG BASE CAPSULE / ORAL RLD 2020-03-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209899-003 ZEPOSIA EQ 0.92MG BASE CAPSULE / ORAL RLD, RS 2020-03-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209899-001 ZEPOSIA EQ 0.23MG BASE CAPSULE / ORAL RLD 2020-03-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209899-002 ZEPOSIA EQ 0.46MG BASE CAPSULE / ORAL RLD 2020-03-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209899-003 ZEPOSIA EQ 0.92MG BASE CAPSULE / ORAL RLD, RS 2020-03-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209899-001 ZEPOSIA EQ 0.23MG BASE CAPSULE / ORAL RLD 2020-03-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209899-002 ZEPOSIA EQ 0.46MG BASE CAPSULE / ORAL RLD 2020-03-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209899-003 ZEPOSIA EQ 0.92MG BASE CAPSULE / ORAL RLD, RS 2020-03-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209899-001 ZEPOSIA EQ 0.23MG BASE CAPSULE / ORAL RLD 2020-03-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209899-002 ZEPOSIA EQ 0.46MG BASE CAPSULE / ORAL RLD 2020-03-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209899-003 ZEPOSIA EQ 0.92MG BASE CAPSULE / ORAL RLD, RS 2020-03-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209899-001 ZEPOSIA EQ 0.23MG BASE CAPSULE / ORAL RLD 2020-03-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209899-002 ZEPOSIA EQ 0.46MG BASE CAPSULE / ORAL RLD 2020-03-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209899-003 ZEPOSIA EQ 0.92MG BASE CAPSULE / ORAL RLD, RS 2020-03-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209899-001 ZEPOSIA EQ 0.23MG BASE CAPSULE / ORAL RLD 2020-03-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209899-002 ZEPOSIA EQ 0.46MG BASE CAPSULE / ORAL RLD 2020-03-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209899-003 ZEPOSIA EQ 0.92MG BASE CAPSULE / ORAL RLD, RS 2020-03-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209899-001 ZEPOSIA EQ 0.23MG BASE CAPSULE / ORAL RLD 2020-03-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209899-002 ZEPOSIA EQ 0.46MG BASE CAPSULE / ORAL RLD 2020-03-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209899-003 ZEPOSIA EQ 0.92MG BASE CAPSULE / ORAL RLD, RS 2020-03-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209899-001 ZEPOSIA EQ 0.23MG BASE CAPSULE / ORAL RLD 2020-03-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N209899-002 ZEPOSIA EQ 0.46MG BASE CAPSULE / ORAL RLD 2020-03-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N209899-003 ZEPOSIA EQ 0.92MG BASE CAPSULE / ORAL RLD, RS 2020-03-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209899-001 ZEPOSIA EQ 0.23MG BASE CAPSULE / ORAL RLD 2020-03-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209899-002 ZEPOSIA EQ 0.46MG BASE CAPSULE / ORAL RLD 2020-03-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209899-003 ZEPOSIA EQ 0.92MG BASE CAPSULE / ORAL RLD, RS 2020-03-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209899-001 ZEPOSIA EQ 0.23MG BASE CAPSULE / ORAL RLD 2020-03-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209899-002 ZEPOSIA EQ 0.46MG BASE CAPSULE / ORAL RLD 2020-03-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209899-003 ZEPOSIA EQ 0.92MG BASE CAPSULE / ORAL RLD, RS 2020-03-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209899-001 ZEPOSIA EQ 0.23MG BASE CAPSULE / ORAL RLD 2020-03-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209899-002 ZEPOSIA EQ 0.46MG BASE CAPSULE / ORAL RLD 2020-03-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209899-003 ZEPOSIA EQ 0.92MG BASE CAPSULE / ORAL RLD, RS 2020-03-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209899-001 ZEPOSIA EQ 0.23MG BASE CAPSULE / ORAL RLD 2020-03-25 8072bd15b7f6…
Observed Orange Book patent history# Patent history page 1 of 14 · 540 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N209899-001 8796318 2029-05-14 Drug substance, Drug product 2020-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209899-001 9382217 2029-05-14 U-2774 2020-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209899-001 10239846 2030-11-15 U-3740 2021-06-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209899-001 8481573 2033-03-24 U-2774 Drug substance, Drug product 2020-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209899-001 11680050 2038-09-30 U-2774 Drug substance, Drug product 2023-11-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209899-001 11680050 2038-09-30 U-3740 Drug substance, Drug product 2023-11-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209899-002 8796318 2029-05-14 Drug substance, Drug product 2020-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209899-002 9382217 2029-05-14 U-2774 2020-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209899-002 10239846 2030-11-15 U-3740 2021-06-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209899-002 8481573 2033-03-24 U-2774 Drug substance, Drug product 2020-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209899-002 11680050 2038-09-30 U-2774 Drug substance, Drug product 2023-11-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209899-002 11680050 2038-09-30 U-3740 Drug substance, Drug product 2023-11-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209899-003 8796318 2029-05-14 Drug substance, Drug product 2020-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209899-003 9382217 2029-05-14 U-2774 2020-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209899-003 10239846 2030-11-15 U-3740 2021-06-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209899-003 8481573 2033-03-24 U-2774 Drug substance, Drug product 2020-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209899-003 11680050 2038-09-30 U-2774 Drug substance, Drug product 2023-11-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209899-003 11680050 2038-09-30 U-3740 Drug substance, Drug product 2023-11-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209899-001 8796318 2029-05-14 Drug substance, Drug product 2020-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209899-001 9382217 2029-05-14 U-2774 2020-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209899-001 10239846 2030-11-15 U-3740 2021-06-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209899-001 8481573 2033-03-24 U-2774 Drug substance, Drug product 2020-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209899-001 11680050 2038-09-30 U-2774 Drug substance, Drug product 2023-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209899-001 11680050 2038-09-30 U-3740 Drug substance, Drug product 2023-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209899-002 8796318 2029-05-14 Drug substance, Drug product 2020-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209899-002 9382217 2029-05-14 U-2774 2020-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209899-002 10239846 2030-11-15 U-3740 2021-06-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209899-002 8481573 2033-03-24 U-2774 Drug substance, Drug product 2020-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209899-002 11680050 2038-09-30 U-2774 Drug substance, Drug product 2023-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209899-002 11680050 2038-09-30 U-3740 Drug substance, Drug product 2023-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209899-003 8796318 2029-05-14 Drug substance, Drug product 2020-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209899-003 9382217 2029-05-14 U-2774 2020-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209899-003 10239846 2030-11-15 U-3740 2021-06-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209899-003 8481573 2033-03-24 U-2774 Drug substance, Drug product 2020-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209899-003 11680050 2038-09-30 U-2774 Drug substance, Drug product 2023-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209899-003 11680050 2038-09-30 U-3740 Drug substance, Drug product 2023-11-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209899-001 8796318 2029-05-14 Drug substance, Drug product 2020-04-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209899-001 9382217 2029-05-14 U-2774 2020-04-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209899-001 10239846 2030-11-15 U-3740 2021-06-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209899-001 8481573 2033-03-24 U-2774 Drug substance, Drug product 2020-04-16 6a471c1ec25d…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 6 · 213 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 27 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 59572-810 ZEPOSIA ozanimod hydrochloride Celgene Corporation NDA Current 59572-810 ZEPOSIA ozanimod hydrochloride Celgene Corporation NDA Current 59572-810 ZEPOSIA ozanimod hydrochloride Celgene Corporation NDA Current 59572-810 ZEPOSIA ozanimod hydrochloride Celgene Corporation NDA Current 59572-810 ZEPOSIA ozanimod hydrochloride Celgene Corporation NDA Current 59572-810 ZEPOSIA ozanimod hydrochloride Celgene Corporation NDA Current 59572-810 ZEPOSIA ozanimod hydrochloride Celgene Corporation NDA Current 59572-810 ZEPOSIA ozanimod hydrochloride Celgene Corporation NDA Current 59572-810 ZEPOSIA ozanimod hydrochloride Celgene Corporation NDA Current 59572-820 ZEPOSIA ozanimod hydrochloride Celgene Corporation NDA Current 59572-820 ZEPOSIA ozanimod hydrochloride Celgene Corporation NDA Current 59572-820 ZEPOSIA ozanimod hydrochloride Celgene Corporation NDA Current 59572-820 ZEPOSIA ozanimod hydrochloride Celgene Corporation NDA Current 59572-820 ZEPOSIA ozanimod hydrochloride Celgene Corporation NDA Current 59572-820 ZEPOSIA ozanimod hydrochloride Celgene Corporation NDA Current 59572-820 ZEPOSIA ozanimod hydrochloride Celgene Corporation NDA Current 59572-820 ZEPOSIA ozanimod hydrochloride Celgene Corporation NDA Current 59572-820 ZEPOSIA ozanimod hydrochloride Celgene Corporation NDA Current 59572-890 ZEPOSIA ozanimod hydrochloride Celgene Corporation NDA Current 59572-890 ZEPOSIA ozanimod hydrochloride Celgene Corporation NDA Current 59572-890 ZEPOSIA ozanimod hydrochloride Celgene Corporation NDA Current 59572-890 ZEPOSIA ozanimod hydrochloride Celgene Corporation NDA Current 59572-890 ZEPOSIA ozanimod hydrochloride Celgene Corporation NDA Current 59572-890 ZEPOSIA ozanimod hydrochloride Celgene Corporation NDA Current 59572-890 ZEPOSIA ozanimod hydrochloride Celgene Corporation NDA Current 59572-890 ZEPOSIA ozanimod hydrochloride Celgene Corporation NDA Current 59572-890 ZEPOSIA ozanimod hydrochloride Celgene Corporation NDA Current