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 1.

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 1 of 2 · 56 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N214962-001	TASCENSO ODT	EQ 0.25MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2021-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214962-002	TASCENSO ODT	EQ 0.5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2022-12-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214962-001	TASCENSO ODT	EQ 0.25MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2021-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214962-002	TASCENSO ODT	EQ 0.5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2022-12-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214962-001	TASCENSO ODT	EQ 0.25MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2021-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214962-002	TASCENSO ODT	EQ 0.5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2022-12-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214962-001	TASCENSO ODT	EQ 0.25MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2021-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214962-002	TASCENSO ODT	EQ 0.5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2022-12-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214962-001	TASCENSO ODT	EQ 0.25MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2021-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214962-002	TASCENSO ODT	EQ 0.5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2022-12-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214962-001	TASCENSO ODT	EQ 0.25MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2021-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214962-002	TASCENSO ODT	EQ 0.5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2022-12-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214962-001	TASCENSO ODT	EQ 0.25MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2021-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214962-002	TASCENSO ODT	EQ 0.5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2022-12-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214962-001	TASCENSO ODT	EQ 0.25MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2021-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214962-002	TASCENSO ODT	EQ 0.5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2022-12-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214962-001	TASCENSO ODT	EQ 0.25MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2021-12-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214962-002	TASCENSO ODT	EQ 0.5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2022-12-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214962-001	TASCENSO ODT	EQ 0.25MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2021-12-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214962-002	TASCENSO ODT	EQ 0.5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2022-12-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214962-001	TASCENSO ODT	EQ 0.25MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2021-12-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214962-002	TASCENSO ODT	EQ 0.5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2022-12-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214962-001	TASCENSO ODT	EQ 0.25MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2021-12-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214962-002	TASCENSO ODT	EQ 0.5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2022-12-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214962-001	TASCENSO ODT	EQ 0.25MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2021-12-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214962-002	TASCENSO ODT	EQ 0.5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2022-12-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214962-001	TASCENSO ODT	EQ 0.25MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2021-12-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N214962-002	TASCENSO ODT	EQ 0.5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2022-12-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214962-001	TASCENSO ODT	EQ 0.25MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2021-12-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214962-001	TASCENSO ODT	EQ 0.25MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2021-12-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214962-001	TASCENSO ODT	EQ 0.25MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2021-12-23	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214962-001	TASCENSO ODT	EQ 0.25MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2021-12-23	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214962-001	TASCENSO ODT	EQ 0.25MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2021-12-23	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214962-002	TASCENSO ODT	EQ 0.5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	RLD, RS	2022-12-09	`6a51e52b5d6a…`
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…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 168 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	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…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214962-002	10925829	2036-01-19		Drug product	2022-12-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214962-002	9925138	2036-01-19		Drug product	2022-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214962-001	10555902	2036-01-19	U-3268		2022-01-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214962-001	10925829	2036-01-19		Drug product	2022-01-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214962-001	9925138	2036-01-19		Drug product	2022-01-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214962-002	10555902	2036-01-19	U-3493		2022-12-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214962-002	10925829	2036-01-19		Drug product	2022-12-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214962-002	9925138	2036-01-19		Drug product	2022-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214962-001	10555902	2036-01-19	U-3268		2022-01-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214962-001	10925829	2036-01-19		Drug product	2022-01-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214962-001	9925138	2036-01-19		Drug product	2022-01-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214962-002	10555902	2036-01-19	U-3493		2022-12-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214962-002	10925829	2036-01-19		Drug product	2022-12-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214962-002	9925138	2036-01-19		Drug product	2022-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214962-001	10555902	2036-01-19	U-3268		2022-01-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214962-001	10925829	2036-01-19		Drug product	2022-01-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214962-001	9925138	2036-01-19		Drug product	2022-01-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214962-002	10555902	2036-01-19	U-3493		2022-12-16	`2680178bc6a6…`

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
TASCENSO ODT	FINGOLIMOD LAURYL SULFATE	Cycle Pharmaceuticals Ltd	bf8e7f89-ea09-43c7-a7eb-e44724350721	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214962 application number: NDA214962 ndc (product): 70709-062

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81152	SUPPL	2025-02-07
80995	SUPPL	2025-02-05
80994	SUPPL	2025-02-05
78730	SUPPL	2024-07-02
78694	SUPPL	2024-06-06
75060	SUPPL	2023-08-14
75048	SUPPL	2023-08-11
75047	ORIG	2022-12-12
72859	ORIG	2022-12-12
72858	ORIG	2022-12-12
70655	ORIG	2022-03-30
69790	ORIG	2021-12-28
69789	ORIG	2021-12-28
69036	ORIG	2021-10-20