Home Applications 209884 Application 209884
Type NDA
Sponsor NOVARTIS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 MAYZENT SIPONIMOD FUMARIC ACID TABLET;ORAL EQ 0.25MG BASE Yes No 002 MAYZENT SIPONIMOD FUMARIC ACID TABLET;ORAL EQ 2MG BASE Yes Yes 003 MAYZENT SIPONIMOD FUMARIC ACID TABLET;ORAL EQ 1MG BASE Yes No
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 N209884-001 MAYZENT SIPONIMOD EQ 0.25MG BASE TABLET / ORAL RLD 2019-03-26 N209884-002 MAYZENT SIPONIMOD EQ 2MG BASE TABLET / ORAL RLD, RS 2019-03-26 N209884-003 MAYZENT SIPONIMOD EQ 1MG BASE TABLET / ORAL RLD 2021-08-24
Orange Book patents# Current patent rows page 1 of 1 · 15 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N209884-001 7939519 2028-08-27 Drug substance, Drug product 2019-04-19 N209884-001 8492441 2030-11-30 U-2511 2019-04-19 N209884-001 12071402 2032-01-05 Drug product 2024-09-26 N209884-001 11944602 2036-04-23 U-3889 2024-04-30 N209884-001 12533340 2036-04-23 U-4407 2026-02-13 N209884-002 7939519 2028-08-27 Drug substance, Drug product 2019-04-19 N209884-002 8492441 2030-11-30 U-2511 2019-04-19 N209884-002 12071402 2032-01-05 Drug product 2024-09-26 N209884-002 11944602 2036-04-23 U-3889 2024-04-30 N209884-002 12533340 2036-04-23 U-4407 2026-02-13 N209884-003 7939519 2028-08-27 Drug substance, Drug product 2021-09-22 N209884-003 8492441 2030-11-30 U-2511 2021-09-22 N209884-003 12071402 2032-01-05 Drug product 2024-09-26 N209884-003 11944602 2036-04-23 U-3889 2024-04-30 N209884-003 12533340 2036-04-23 U-4407 2026-02-13
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 · 115 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 N209884-001 MAYZENT EQ 0.25MG BASE TABLET / ORAL RLD 2019-03-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209884-002 MAYZENT EQ 2MG BASE TABLET / ORAL RLD, RS 2019-03-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209884-003 MAYZENT EQ 1MG BASE TABLET / ORAL RLD 2021-08-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209884-001 MAYZENT EQ 0.25MG BASE TABLET / ORAL RLD 2019-03-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209884-002 MAYZENT EQ 2MG BASE TABLET / ORAL RLD, RS 2019-03-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209884-003 MAYZENT EQ 1MG BASE TABLET / ORAL RLD 2021-08-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209884-001 MAYZENT EQ 0.25MG BASE TABLET / ORAL RLD 2019-03-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209884-002 MAYZENT EQ 2MG BASE TABLET / ORAL RLD, RS 2019-03-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209884-003 MAYZENT EQ 1MG BASE TABLET / ORAL RLD 2021-08-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209884-001 MAYZENT EQ 0.25MG BASE TABLET / ORAL RLD 2019-03-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209884-002 MAYZENT EQ 2MG BASE TABLET / ORAL RLD, RS 2019-03-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209884-003 MAYZENT EQ 1MG BASE TABLET / ORAL RLD 2021-08-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209884-001 MAYZENT EQ 0.25MG BASE TABLET / ORAL RLD 2019-03-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209884-002 MAYZENT EQ 2MG BASE TABLET / ORAL RLD, RS 2019-03-26 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209884-003 MAYZENT EQ 1MG BASE TABLET / ORAL RLD 2021-08-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209884-001 MAYZENT EQ 0.25MG BASE TABLET / ORAL RLD 2019-03-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209884-002 MAYZENT EQ 2MG BASE TABLET / ORAL RLD, RS 2019-03-26 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209884-003 MAYZENT EQ 1MG BASE TABLET / ORAL RLD 2021-08-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209884-001 MAYZENT EQ 0.25MG BASE TABLET / ORAL RLD 2019-03-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209884-002 MAYZENT EQ 2MG BASE TABLET / ORAL RLD, RS 2019-03-26 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209884-003 MAYZENT EQ 1MG BASE TABLET / ORAL RLD 2021-08-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209884-001 MAYZENT EQ 0.25MG BASE TABLET / ORAL RLD 2019-03-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209884-002 MAYZENT EQ 2MG BASE TABLET / ORAL RLD, RS 2019-03-26 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209884-003 MAYZENT EQ 1MG BASE TABLET / ORAL RLD 2021-08-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209884-001 MAYZENT EQ 0.25MG BASE TABLET / ORAL RLD 2019-03-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209884-002 MAYZENT EQ 2MG BASE TABLET / ORAL RLD, RS 2019-03-26 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209884-003 MAYZENT EQ 1MG BASE TABLET / ORAL RLD 2021-08-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209884-001 MAYZENT EQ 0.25MG BASE TABLET / ORAL RLD 2019-03-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N209884-002 MAYZENT EQ 2MG BASE TABLET / ORAL RLD, RS 2019-03-26 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N209884-003 MAYZENT EQ 1MG BASE TABLET / ORAL RLD 2021-08-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209884-001 MAYZENT EQ 0.25MG BASE TABLET / ORAL RLD 2019-03-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209884-002 MAYZENT EQ 2MG BASE TABLET / ORAL RLD, RS 2019-03-26 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209884-003 MAYZENT EQ 1MG BASE TABLET / ORAL RLD 2021-08-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209884-001 MAYZENT EQ 0.25MG BASE TABLET / ORAL RLD 2019-03-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209884-002 MAYZENT EQ 2MG BASE TABLET / ORAL RLD, RS 2019-03-26 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209884-003 MAYZENT EQ 1MG BASE TABLET / ORAL RLD 2021-08-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209884-001 MAYZENT EQ 0.25MG BASE TABLET / ORAL RLD 2019-03-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209884-002 MAYZENT EQ 2MG BASE TABLET / ORAL RLD, RS 2019-03-26 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209884-003 MAYZENT EQ 1MG BASE TABLET / ORAL RLD 2021-08-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209884-001 MAYZENT EQ 0.25MG BASE TABLET / ORAL RLD 2019-03-26 8072bd15b7f6…
Observed Orange Book patent history# Patent history page 1 of 8 · 308 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 N209884-001 7939519 2028-08-27 Drug substance, Drug product 2019-04-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209884-001 8492441 2030-11-30 U-2511 2019-04-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209884-001 12071402 2032-01-05 Drug product 2024-09-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209884-001 11944602 2036-04-23 U-3889 2024-04-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209884-002 7939519 2028-08-27 Drug substance, Drug product 2019-04-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209884-002 8492441 2030-11-30 U-2511 2019-04-19 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209884-002 12071402 2032-01-05 Drug product 2024-09-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209884-002 11944602 2036-04-23 U-3889 2024-04-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209884-003 7939519 2028-08-27 Drug substance, Drug product 2021-09-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209884-003 8492441 2030-11-30 U-2511 2021-09-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209884-003 12071402 2032-01-05 Drug product 2024-09-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209884-003 11944602 2036-04-23 U-3889 2024-04-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209884-001 7939519 2028-08-27 Drug substance, Drug product 2019-04-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209884-001 8492441 2030-11-30 U-2511 2019-04-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209884-001 12071402 2032-01-05 Drug product 2024-09-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209884-001 11944602 2036-04-23 U-3889 2024-04-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209884-002 7939519 2028-08-27 Drug substance, Drug product 2019-04-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209884-002 8492441 2030-11-30 U-2511 2019-04-19 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209884-002 12071402 2032-01-05 Drug product 2024-09-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209884-002 11944602 2036-04-23 U-3889 2024-04-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209884-003 7939519 2028-08-27 Drug substance, Drug product 2021-09-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209884-003 8492441 2030-11-30 U-2511 2021-09-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209884-003 12071402 2032-01-05 Drug product 2024-09-26 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209884-003 11944602 2036-04-23 U-3889 2024-04-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209884-001 7939519 2028-08-27 Drug substance, Drug product 2019-04-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209884-001 8492441 2030-11-30 U-2511 2019-04-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209884-001 12071402 2032-01-05 Drug product 2024-09-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209884-001 11944602 2036-04-23 U-3889 2024-04-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209884-002 7939519 2028-08-27 Drug substance, Drug product 2019-04-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209884-002 8492441 2030-11-30 U-2511 2019-04-19 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209884-002 12071402 2032-01-05 Drug product 2024-09-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209884-002 11944602 2036-04-23 U-3889 2024-04-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209884-003 7939519 2028-08-27 Drug substance, Drug product 2021-09-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209884-003 8492441 2030-11-30 U-2511 2021-09-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209884-003 12071402 2032-01-05 Drug product 2024-09-26 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209884-003 11944602 2036-04-23 U-3889 2024-04-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209884-001 7939519 2028-08-27 Drug substance, Drug product 2019-04-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209884-001 8492441 2030-11-30 U-2511 2019-04-19 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209884-001 12071402 2032-01-05 Drug product 2024-09-26 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209884-001 11944602 2036-07-24 U-3889 2024-04-30 fd3edfee7708…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 5 · 178 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 · 21 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0078-0979 MAYZENT siponimod Novartis Pharmaceuticals Corporation NDA Current 0078-0979 MAYZENT siponimod Novartis Pharmaceuticals Corporation NDA Current 0078-0979 MAYZENT siponimod Novartis Pharmaceuticals Corporation NDA Current 0078-0979 MAYZENT siponimod Novartis Pharmaceuticals Corporation NDA Current 0078-0979 MAYZENT siponimod Novartis Pharmaceuticals Corporation NDA Current 0078-0979 MAYZENT siponimod Novartis Pharmaceuticals Corporation NDA Current 0078-0979 MAYZENT siponimod Novartis Pharmaceuticals Corporation NDA Current 0078-0979 MAYZENT siponimod Novartis Pharmaceuticals Corporation NDA Current 0078-0979 MAYZENT siponimod Novartis Pharmaceuticals Corporation NDA Current 0078-0986 MAYZENT siponimod Novartis Pharmaceuticals Corporation NDA Current 0078-0986 MAYZENT siponimod Novartis Pharmaceuticals Corporation NDA Current 0078-0986 MAYZENT siponimod Novartis Pharmaceuticals Corporation NDA Current 0078-0986 MAYZENT siponimod Novartis Pharmaceuticals Corporation NDA Current 0078-0986 MAYZENT siponimod Novartis Pharmaceuticals Corporation NDA Current 0078-0986 MAYZENT siponimod Novartis Pharmaceuticals Corporation NDA Current 0078-0986 MAYZENT siponimod Novartis Pharmaceuticals Corporation NDA Current 0078-0986 MAYZENT siponimod Novartis Pharmaceuticals Corporation NDA Current 0078-0986 MAYZENT siponimod Novartis Pharmaceuticals Corporation NDA Current 0078-1014 MAYZENT siponimod Novartis Pharmaceuticals Corporation NDA Current 0078-1014 MAYZENT siponimod Novartis Pharmaceuticals Corporation NDA Current 0078-1014 MAYZENT siponimod Novartis Pharmaceuticals Corporation NDA Current