Application 216578

Type: NDA
Sponsor: ASTELLAS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VEOZAH	FEZOLINETANT	TABLET;ORAL	45MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N216578-001	VEOZAH	FEZOLINETANT	45MG	TABLET / ORAL		RLD, RS	2023-05-12

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N216578-001	8871761	2031-04-04		Drug substance	2023-06-06
N216578-001	10836768	2034-03-28	U-3622		2023-06-06
N216578-001	9422299	2034-03-28	U-3622	Drug substance, Drug product	2023-06-06
N216578-001	9987274	2034-03-28	U-3622		2023-06-06

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N216578-001	NCE	2028-05-12

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.

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	N216578-001	VEOZAH	45MG	TABLET / ORAL	RLD, RS	2023-05-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216578-001	VEOZAH	45MG	TABLET / ORAL	RLD, RS	2023-05-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216578-001	VEOZAH	45MG	TABLET / ORAL	RLD, RS	2023-05-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216578-001	VEOZAH	45MG	TABLET / ORAL	RLD, RS	2023-05-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216578-001	VEOZAH	45MG	TABLET / ORAL	RLD, RS	2023-05-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216578-001	VEOZAH	45MG	TABLET / ORAL	RLD, RS	2023-05-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216578-001	VEOZAH	45MG	TABLET / ORAL	RLD, RS	2023-05-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216578-001	VEOZAH	45MG	TABLET / ORAL	RLD, RS	2023-05-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216578-001	VEOZAH	45MG	TABLET / ORAL	RLD, RS	2023-05-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216578-001	VEOZAH	45MG	TABLET / ORAL	RLD, RS	2023-05-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216578-001	VEOZAH	45MG	TABLET / ORAL	RLD, RS	2023-05-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216578-001	VEOZAH	45MG	TABLET / ORAL	RLD, RS	2023-05-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216578-001	VEOZAH	45MG	TABLET / ORAL	RLD, RS	2023-05-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216578-001	VEOZAH	45MG	TABLET / ORAL	RLD, RS	2023-05-12	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216578-001	VEOZAH	45MG	TABLET / ORAL	RLD, RS	2023-05-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N216578-001	VEOZAH	45MG	TABLET / ORAL	RLD, RS	2023-05-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N216578-001	VEOZAH	45MG	TABLET / ORAL	RLD, RS	2023-05-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216578-001	VEOZAH	45MG	TABLET / ORAL	RLD, RS	2023-05-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N216578-001	VEOZAH	45MG	TABLET / ORAL	RLD, RS	2023-05-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N216578-001	VEOZAH	45MG	TABLET / ORAL	RLD, RS	2023-05-12	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N216578-001	VEOZAH	45MG	TABLET / ORAL	RLD, RS	2023-05-12	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216578-001	VEOZAH	45MG	TABLET / ORAL	RLD, RS	2023-05-12	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 88 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	N216578-001	8871761	2031-04-04		Drug substance	2023-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216578-001	10836768	2034-03-28	U-3622		2023-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216578-001	9422299	2034-03-28	U-3622	Drug substance, Drug product	2023-06-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216578-001	9987274	2034-03-28	U-3622		2023-06-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216578-001	8871761	2031-04-04		Drug substance	2023-06-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216578-001	10836768	2034-03-28	U-3622		2023-06-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216578-001	9422299	2034-03-28	U-3622	Drug substance, Drug product	2023-06-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216578-001	9987274	2034-03-28	U-3622		2023-06-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216578-001	8871761	2031-04-04		Drug substance	2023-06-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216578-001	10836768	2034-03-28	U-3621		2023-06-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216578-001	9422299	2034-03-28	U-3622	Drug substance, Drug product	2023-06-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216578-001	9987274	2034-03-28	U-3622		2023-06-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216578-001	8871761	2031-04-04		Drug substance	2023-06-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216578-001	10836768	2034-03-28	U-3621		2023-06-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216578-001	9422299	2034-03-28	U-3622	Drug substance, Drug product	2023-06-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216578-001	9987274	2034-03-28	U-3622		2023-06-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216578-001	8871761	2031-04-04		Drug substance	2023-06-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216578-001	10836768	2034-03-28	U-3621		2023-06-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216578-001	9422299	2034-03-28	U-3622	Drug substance, Drug product	2023-06-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216578-001	9987274	2034-03-28	U-3622		2023-06-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216578-001	8871761	2031-04-04		Drug substance	2023-06-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216578-001	10836768	2034-03-28	U-3621		2023-06-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216578-001	9422299	2034-03-28	U-3622	Drug substance, Drug product	2023-06-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216578-001	9987274	2034-03-28	U-3622		2023-06-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216578-001	8871761	2031-04-04		Drug substance	2023-06-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216578-001	10836768	2034-03-28	U-3621		2023-06-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216578-001	9422299	2034-03-28	U-3622	Drug substance, Drug product	2023-06-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216578-001	9987274	2034-03-28	U-3622		2023-06-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216578-001	8871761	2031-04-04		Drug substance	2023-06-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216578-001	10836768	2034-03-28	U-3621		2023-06-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216578-001	9422299	2034-03-28	U-3622	Drug substance, Drug product	2023-06-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216578-001	9987274	2034-03-28	U-3622		2023-06-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216578-001	8871761	2031-04-04		Drug substance	2023-06-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216578-001	10836768	2034-03-28	U-3621		2023-06-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216578-001	9422299	2034-03-28	U-3622	Drug substance, Drug product	2023-06-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216578-001	9987274	2034-03-28	U-3622		2023-06-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216578-001	8871761	2031-04-04		Drug substance	2023-06-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216578-001	10836768	2034-03-28	U-3621		2023-06-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216578-001	9422299	2034-03-28	U-3622	Drug substance, Drug product	2023-06-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N216578-001	9987274	2034-03-28	U-3622		2023-06-06	`d06236e962d9…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N216578-001	NCE	2028-05-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216578-001	NCE	2028-05-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216578-001	NCE	2028-05-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216578-001	NCE	2028-05-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216578-001	NCE	2028-05-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216578-001	NCE	2028-05-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216578-001	NCE	2028-05-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216578-001	NCE	2028-05-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216578-001	NCE	2028-05-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216578-001	NCE	2028-05-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216578-001	NCE	2028-05-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216578-001	NCE	2028-05-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216578-001	NCE	2028-05-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216578-001	NCE	2028-05-12	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216578-001	NCE	2028-05-12	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N216578-001	NCE	2028-05-12	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N216578-001	NCE	2028-05-12	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216578-001	NCE	2028-05-12	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N216578-001	NCE	2028-05-12	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N216578-001	NCE	2028-05-12	`a67488948f0b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216578-001	NCE	2028-05-12	`a50c72e98297…`

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
VEOZAH	FEZOLINETANT	Astellas Pharma US, Inc.	cae9f798-24f9-4580-a4fc-e6c710cbda3c	2026-02-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 216578 application number: NDA216578

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80617	SUPPL	2024-12-18
80599	SUPPL	2024-12-17
79559	SUPPL	2024-09-09
79537	SUPPL	2024-09-03
74616	ORIG	2023-06-23
74247	ORIG	2023-05-15
74246	ORIG	2023-05-15