Home Applications 214962 Application 214962
Type NDA
Sponsor HANDA NEUROSCIENCE LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TASCENSO ODT FINGOLIMOD LAURYL SULFATE TABLET;ORALLY DISINTEGRATING 0.25MG No No 002 TASCENSO ODT FINGOLIMOD LAURYL SULFATE TABLET;ORALLY DISINTEGRATING 0.5MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N214962-001 TASCENSO ODT FINGOLIMOD LAURYL SULFATE EQ 0.25MG BASE TABLET, ORALLY DISINTEGRATING / ORAL RLD 2021-12-23 N214962-002 TASCENSO ODT FINGOLIMOD LAURYL SULFATE EQ 0.5MG BASE TABLET, ORALLY DISINTEGRATING / ORAL RLD, RS 2022-12-09
Orange Book patents# Current patent rows page 1 of 1 · 6 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N214962-001 10555902 2036-01-19 U-3268 2022-01-11 N214962-001 10925829 2036-01-19 Drug product 2022-01-11 N214962-001 9925138 2036-01-19 Drug product 2022-01-11 N214962-002 10555902 2036-01-19 U-3493 2022-12-16 N214962-002 10925829 2036-01-19 Drug product 2022-12-16 N214962-002 9925138 2036-01-19 Drug product 2022-12-16
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 2 of 2 · 62 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 2024-02-18 07:12 UTC 2024-02 N214962-001 TASCENSO ODT EQ 0.25MG BASE TABLET, ORALLY DISINTEGRATING / ORAL RLD 2021-12-23 1c564ffb4f44…2024-02-18 07:12 UTC 2024-02 N214962-002 TASCENSO ODT EQ 0.5MG BASE TABLET, ORALLY DISINTEGRATING / ORAL RLD, RS 2022-12-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214962-001 TASCENSO ODT EQ 0.25MG BASE TABLET, ORALLY DISINTEGRATING / ORAL RLD 2021-12-23 ea1830bbd6c7…2023-12-20 04:57 UTC 2023-12 N214962-002 TASCENSO ODT EQ 0.5MG BASE TABLET, ORALLY DISINTEGRATING / ORAL RLD, RS 2022-12-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214962-001 TASCENSO ODT EQ 0.25MG BASE TABLET, ORALLY DISINTEGRATING / ORAL RLD 2021-12-23 a72a2bbeb626…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214962-002 TASCENSO ODT EQ 0.5MG BASE TABLET, ORALLY DISINTEGRATING / ORAL RLD, RS 2022-12-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214962-001 TASCENSO ODT EQ 0.25MG BASE TABLET, ORALLY DISINTEGRATING / ORAL RLD 2021-12-23 9b2671bbb829…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214962-002 TASCENSO ODT EQ 0.5MG BASE TABLET, ORALLY DISINTEGRATING / ORAL RLD, RS 2022-12-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214962-001 TASCENSO ODT EQ 0.25MG BASE TABLET, ORALLY DISINTEGRATING / ORAL RLD 2021-12-23 a67488948f0b…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214962-002 TASCENSO ODT EQ 0.5MG BASE TABLET, ORALLY DISINTEGRATING / ORAL RLD, RS 2022-12-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214962-001 TASCENSO ODT EQ 0.25MG BASE TABLET, ORALLY DISINTEGRATING / ORAL RLD 2021-12-23 3f0d92c62455…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214962-002 TASCENSO ODT EQ 0.5MG BASE TABLET, ORALLY DISINTEGRATING / ORAL RLD, RS 2022-12-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214962-001 TASCENSO ODT EQ 0.25MG BASE TABLET, ORALLY DISINTEGRATING / ORAL RLD 2021-12-23 053a50430f4f…2023-05-13 08:27 UTC 2023-05 N214962-002 TASCENSO ODT EQ 0.5MG BASE TABLET, ORALLY DISINTEGRATING / ORAL RLD, RS 2022-12-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214962-001 TASCENSO ODT EQ 0.25MG BASE TABLET, ORALLY DISINTEGRATING / ORAL RLD 2021-12-23 3bdfa0b2c4d7…2023-01-26 05:58 UTC 2023-01 N214962-002 TASCENSO ODT EQ 0.5MG BASE TABLET, ORALLY DISINTEGRATING / ORAL RLD, RS 2022-12-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214962-001 TASCENSO ODT EQ 0.25MG BASE TABLET, ORALLY DISINTEGRATING / ORAL RLD 2021-12-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N214962-001 TASCENSO ODT EQ 0.25MG BASE TABLET, ORALLY DISINTEGRATING / ORAL RLD 2021-12-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N214962-001 TASCENSO ODT EQ 0.25MG BASE TABLET, ORALLY DISINTEGRATING / ORAL RLD, RS 2021-12-23 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N214962-001 TASCENSO ODT EQ 0.25MG BASE TABLET, ORALLY DISINTEGRATING / ORAL RLD, RS 2021-12-23 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214962-001 TASCENSO ODT EQ 0.25MG BASE TABLET, ORALLY DISINTEGRATING / ORAL RLD 2021-12-23 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N214962-002 TASCENSO ODT EQ 0.5MG BASE TABLET, ORALLY DISINTEGRATING / ORAL RLD, RS 2022-12-09 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 5 · 186 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N214962-001 10555902 2036-01-19 U-3268 2022-01-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214962-001 10925829 2036-01-19 Drug product 2022-01-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214962-001 9925138 2036-01-19 Drug product 2022-01-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214962-002 10555902 2036-01-19 U-3493 2022-12-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214962-002 10925829 2036-01-19 Drug product 2022-12-16 c2088c7a36db…2026-10-15 13:18:30 2026-09 N214962-002 9925138 2036-01-19 Drug product 2022-12-16 c2088c7a36db…2026-09-14 22:38:34 2026-08 N214962-001 10555902 2036-01-19 U-3268 2022-01-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214962-001 10925829 2036-01-19 Drug product 2022-01-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214962-001 9925138 2036-01-19 Drug product 2022-01-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214962-002 10555902 2036-01-19 U-3493 2022-12-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214962-002 10925829 2036-01-19 Drug product 2022-12-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 N214962-002 9925138 2036-01-19 Drug product 2022-12-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 N214962-001 10555902 2036-01-19 U-3268 2022-01-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214962-001 10925829 2036-01-19 Drug product 2022-01-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214962-001 9925138 2036-01-19 Drug product 2022-01-11 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214962-002 10555902 2036-01-19 U-3493 2022-12-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214962-002 10925829 2036-01-19 Drug product 2022-12-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N214962-002 9925138 2036-01-19 Drug product 2022-12-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N214962-001 10555902 2036-01-19 U-3268 2022-01-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214962-001 10925829 2036-01-19 Drug product 2022-01-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214962-001 9925138 2036-01-19 Drug product 2022-01-11 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214962-002 10555902 2036-01-19 U-3493 2022-12-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214962-002 10925829 2036-01-19 Drug product 2022-12-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214962-002 9925138 2036-01-19 Drug product 2022-12-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214962-001 10555902 2036-01-19 U-3268 2022-01-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214962-001 10925829 2036-01-19 Drug product 2022-01-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214962-001 9925138 2036-01-19 Drug product 2022-01-11 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214962-002 10555902 2036-01-19 U-3493 2022-12-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214962-002 10925829 2036-01-19 Drug product 2022-12-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214962-002 9925138 2036-01-19 Drug product 2022-12-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214962-001 10555902 2036-01-19 U-3268 2022-01-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214962-001 10925829 2036-01-19 Drug product 2022-01-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214962-001 9925138 2036-01-19 Drug product 2022-01-11 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214962-002 10555902 2036-01-19 U-3493 2022-12-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214962-002 10925829 2036-01-19 Drug product 2022-12-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214962-002 9925138 2036-01-19 Drug product 2022-12-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214962-001 10555902 2036-01-19 U-3268 2022-01-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214962-001 10925829 2036-01-19 Drug product 2022-01-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214962-001 9925138 2036-01-19 Drug product 2022-01-11 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214962-002 10555902 2036-01-19 U-3493 2022-12-16 fd3edfee7708…
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.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 1 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 70709-062 TASCENSO ODT Fingolimod Lauryl Sulfate Cycle Pharmaceuticals Ltd NDA Current