Application 213498

Type: NDA
Sponsor: JANSSEN PHARMACEUTICALS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PONVORY	PONESIMOD	TABLET;ORAL	2MG	Yes	No
002	PONVORY	PONESIMOD	TABLET;ORAL	3MG	Yes	No
003	PONVORY	PONESIMOD	TABLET;ORAL	4MG	Yes	No
004	PONVORY	PONESIMOD	TABLET;ORAL	5MG	Yes	No
005	PONVORY	PONESIMOD	TABLET;ORAL	6MG	Yes	No
006	PONVORY	PONESIMOD	TABLET;ORAL	7MG	Yes	No
007	PONVORY	PONESIMOD	TABLET;ORAL	8MG	Yes	No
008	PONVORY	PONESIMOD	TABLET;ORAL	9MG	Yes	No
009	PONVORY	PONESIMOD	TABLET;ORAL	10MG	Yes	No
010	PONVORY	PONESIMOD	TABLET;ORAL	20MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 10 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N213498-001	PONVORY	PONESIMOD	2MG	TABLET / ORAL	RLD, RS	2021-03-18
N213498-002	PONVORY	PONESIMOD	3MG	TABLET / ORAL	RLD	2021-03-18
N213498-003	PONVORY	PONESIMOD	4MG	TABLET / ORAL	RLD	2021-03-18
N213498-004	PONVORY	PONESIMOD	5MG	TABLET / ORAL	RLD	2021-03-18
N213498-005	PONVORY	PONESIMOD	6MG	TABLET / ORAL	RLD	2021-03-18
N213498-006	PONVORY	PONESIMOD	7MG	TABLET / ORAL	RLD	2021-03-18
N213498-007	PONVORY	PONESIMOD	8MG	TABLET / ORAL	RLD	2021-03-18
N213498-008	PONVORY	PONESIMOD	9MG	TABLET / ORAL	RLD	2021-03-18
N213498-009	PONVORY	PONESIMOD	10MG	TABLET / ORAL	RLD	2021-03-18
N213498-010	PONVORY	PONESIMOD	20MG	TABLET / ORAL	RLD	2021-03-18

Orange Book patents#

Current patent rows page 1 of 1 · 50 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213498-001	RE43728	2029-11-16		Drug substance, Drug product	2021-04-14
N213498-001	9062014	2032-05-06	U-2774	Drug substance, Drug product	2021-04-14
N213498-001	10220023	2035-12-10	U-3103		2021-04-14
N213498-001	12336980	2035-12-10	U-3103		2025-07-08
N213498-001	11951097	2042-10-10	U-3891		2024-05-02
N213498-002	RE43728	2029-11-16		Drug substance, Drug product	2021-04-14
N213498-002	9062014	2032-05-06	U-2774	Drug substance, Drug product	2021-04-14
N213498-002	10220023	2035-12-10	U-3103		2021-04-14
N213498-002	12336980	2035-12-10	U-3103		2025-07-08
N213498-002	11951097	2042-10-10	U-3891		2024-05-02
N213498-003	RE43728	2029-11-16		Drug substance, Drug product	2021-04-14
N213498-003	9062014	2032-05-06	U-2774	Drug substance, Drug product	2021-04-14
N213498-003	10220023	2035-12-10	U-3103		2021-04-14
N213498-003	12336980	2035-12-10	U-3103		2025-07-08
N213498-003	11951097	2042-10-10	U-3891		2024-05-02
N213498-004	RE43728	2029-11-16		Drug substance, Drug product	2021-04-14
N213498-004	9062014	2032-05-06	U-2774	Drug substance, Drug product	2021-04-14
N213498-004	10220023	2035-12-10	U-3103		2021-04-14
N213498-004	12336980	2035-12-10	U-3103		2025-07-08
N213498-004	11951097	2042-10-10	U-3891		2024-05-02
N213498-005	RE43728	2029-11-16		Drug substance, Drug product	2021-04-14
N213498-005	9062014	2032-05-06	U-2774	Drug substance, Drug product	2021-04-14
N213498-005	10220023	2035-12-10	U-3103		2021-04-14
N213498-005	12336980	2035-12-10	U-3103		2025-07-08
N213498-005	11951097	2042-10-10	U-3891		2024-05-02
N213498-006	RE43728	2029-11-16		Drug substance, Drug product	2021-04-14
N213498-006	9062014	2032-05-06	U-2774	Drug substance, Drug product	2021-04-14
N213498-006	10220023	2035-12-10	U-3103		2021-04-14
N213498-006	12336980	2035-12-10	U-3103		2025-07-08
N213498-006	11951097	2042-10-10	U-3891		2024-05-02
N213498-007	RE43728	2029-11-16		Drug substance, Drug product	2021-04-14
N213498-007	9062014	2032-05-06	U-2774	Drug substance, Drug product	2021-04-14
N213498-007	10220023	2035-12-10	U-3103		2021-04-14
N213498-007	12336980	2035-12-10	U-3103		2025-07-08
N213498-007	11951097	2042-10-10	U-3891		2024-05-02
N213498-008	RE43728	2029-11-16		Drug substance, Drug product	2021-04-14
N213498-008	9062014	2032-05-06	U-2774	Drug substance, Drug product	2021-04-14
N213498-008	10220023	2035-12-10	U-3103		2021-04-14
N213498-008	12336980	2035-12-10	U-3103		2025-07-08
N213498-008	11951097	2042-10-10	U-3891		2024-05-02
N213498-009	RE43728	2029-11-16		Drug substance, Drug product	2021-04-14
N213498-009	9062014	2032-05-06	U-2774	Drug substance, Drug product	2021-04-14
N213498-009	10220023	2035-12-10	U-3103		2021-04-14
N213498-009	12336980	2035-12-10	U-3103		2025-07-08
N213498-009	11951097	2042-10-10	U-3891		2024-05-02
N213498-010	RE43728	2029-11-16		Drug substance, Drug product	2021-04-14
N213498-010	9062014	2032-05-06	U-2774	Drug substance, Drug product	2021-04-14
N213498-010	10220023	2035-12-10	U-3103		2021-04-14
N213498-010	12336980	2035-12-10	U-3103		2025-07-08
N213498-010	11951097	2042-10-10	U-3891		2024-05-02

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 10 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N213498-001	NCE	2026-03-18
N213498-002	NCE	2026-03-18
N213498-003	NCE	2026-03-18
N213498-004	NCE	2026-03-18
N213498-005	NCE	2026-03-18
N213498-006	NCE	2026-03-18
N213498-007	NCE	2026-03-18
N213498-008	NCE	2026-03-18
N213498-009	NCE	2026-03-18
N213498-010	NCE	2026-03-18

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 9 · 360 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N213498-001	PONVORY	2MG	TABLET / ORAL	RLD, RS	2021-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-002	PONVORY	3MG	TABLET / ORAL	RLD	2021-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-003	PONVORY	4MG	TABLET / ORAL	RLD	2021-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-004	PONVORY	5MG	TABLET / ORAL	RLD	2021-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-005	PONVORY	6MG	TABLET / ORAL	RLD	2021-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-006	PONVORY	7MG	TABLET / ORAL	RLD	2021-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-007	PONVORY	8MG	TABLET / ORAL	RLD	2021-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-008	PONVORY	9MG	TABLET / ORAL	RLD	2021-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-009	PONVORY	10MG	TABLET / ORAL	RLD	2021-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-010	PONVORY	20MG	TABLET / ORAL	RLD	2021-03-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213498-001	PONVORY	2MG	TABLET / ORAL	RLD, RS	2021-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213498-002	PONVORY	3MG	TABLET / ORAL	RLD	2021-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213498-003	PONVORY	4MG	TABLET / ORAL	RLD	2021-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213498-004	PONVORY	5MG	TABLET / ORAL	RLD	2021-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213498-005	PONVORY	6MG	TABLET / ORAL	RLD	2021-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213498-006	PONVORY	7MG	TABLET / ORAL	RLD	2021-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213498-007	PONVORY	8MG	TABLET / ORAL	RLD	2021-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213498-008	PONVORY	9MG	TABLET / ORAL	RLD	2021-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213498-009	PONVORY	10MG	TABLET / ORAL	RLD	2021-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213498-010	PONVORY	20MG	TABLET / ORAL	RLD	2021-03-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213498-001	PONVORY	2MG	TABLET / ORAL	RLD, RS	2021-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213498-002	PONVORY	3MG	TABLET / ORAL	RLD	2021-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213498-003	PONVORY	4MG	TABLET / ORAL	RLD	2021-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213498-004	PONVORY	5MG	TABLET / ORAL	RLD	2021-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213498-005	PONVORY	6MG	TABLET / ORAL	RLD	2021-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213498-006	PONVORY	7MG	TABLET / ORAL	RLD	2021-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213498-007	PONVORY	8MG	TABLET / ORAL	RLD	2021-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213498-008	PONVORY	9MG	TABLET / ORAL	RLD	2021-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213498-009	PONVORY	10MG	TABLET / ORAL	RLD	2021-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213498-010	PONVORY	20MG	TABLET / ORAL	RLD	2021-03-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213498-001	PONVORY	2MG	TABLET / ORAL	RLD, RS	2021-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213498-002	PONVORY	3MG	TABLET / ORAL	RLD	2021-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213498-003	PONVORY	4MG	TABLET / ORAL	RLD	2021-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213498-004	PONVORY	5MG	TABLET / ORAL	RLD	2021-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213498-005	PONVORY	6MG	TABLET / ORAL	RLD	2021-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213498-006	PONVORY	7MG	TABLET / ORAL	RLD	2021-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213498-007	PONVORY	8MG	TABLET / ORAL	RLD	2021-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213498-008	PONVORY	9MG	TABLET / ORAL	RLD	2021-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213498-009	PONVORY	10MG	TABLET / ORAL	RLD	2021-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213498-010	PONVORY	20MG	TABLET / ORAL	RLD	2021-03-18	`31067a03dcf5…`

Observed Orange Book patent history#

Patent history page 1 of 47 · 1,860 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N213498-001	RE43728	2029-11-16		Drug substance, Drug product	2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-001	9062014	2032-05-06	U-2774	Drug substance, Drug product	2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-001	10220023	2035-12-10	U-3103		2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-001	12336980	2035-12-10	U-3103		2025-07-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-001	11951097	2042-10-10	U-3891		2024-05-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-002	RE43728	2029-11-16		Drug substance, Drug product	2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-002	9062014	2032-05-06	U-2774	Drug substance, Drug product	2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-002	10220023	2035-12-10	U-3103		2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-002	12336980	2035-12-10	U-3103		2025-07-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-002	11951097	2042-10-10	U-3891		2024-05-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-003	RE43728	2029-11-16		Drug substance, Drug product	2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-003	9062014	2032-05-06	U-2774	Drug substance, Drug product	2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-003	10220023	2035-12-10	U-3103		2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-003	12336980	2035-12-10	U-3103		2025-07-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-003	11951097	2042-10-10	U-3891		2024-05-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-004	RE43728	2029-11-16		Drug substance, Drug product	2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-004	9062014	2032-05-06	U-2774	Drug substance, Drug product	2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-004	10220023	2035-12-10	U-3103		2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-004	12336980	2035-12-10	U-3103		2025-07-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-004	11951097	2042-10-10	U-3891		2024-05-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-005	RE43728	2029-11-16		Drug substance, Drug product	2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-005	9062014	2032-05-06	U-2774	Drug substance, Drug product	2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-005	10220023	2035-12-10	U-3103		2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-005	12336980	2035-12-10	U-3103		2025-07-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-005	11951097	2042-10-10	U-3891		2024-05-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-006	RE43728	2029-11-16		Drug substance, Drug product	2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-006	9062014	2032-05-06	U-2774	Drug substance, Drug product	2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-006	10220023	2035-12-10	U-3103		2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-006	12336980	2035-12-10	U-3103		2025-07-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-006	11951097	2042-10-10	U-3891		2024-05-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-007	RE43728	2029-11-16		Drug substance, Drug product	2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-007	9062014	2032-05-06	U-2774	Drug substance, Drug product	2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-007	10220023	2035-12-10	U-3103		2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-007	12336980	2035-12-10	U-3103		2025-07-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-007	11951097	2042-10-10	U-3891		2024-05-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-008	RE43728	2029-11-16		Drug substance, Drug product	2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-008	9062014	2032-05-06	U-2774	Drug substance, Drug product	2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-008	10220023	2035-12-10	U-3103		2021-04-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-008	12336980	2035-12-10	U-3103		2025-07-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-008	11951097	2042-10-10	U-3891		2024-05-02	`84e616aacf4f…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 9 · 360 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N213498-001	NCE	2026-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-002	NCE	2026-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-003	NCE	2026-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-004	NCE	2026-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-005	NCE	2026-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-006	NCE	2026-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-007	NCE	2026-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-008	NCE	2026-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-009	NCE	2026-03-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N213498-010	NCE	2026-03-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213498-001	NCE	2026-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213498-002	NCE	2026-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213498-003	NCE	2026-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213498-004	NCE	2026-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213498-005	NCE	2026-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213498-006	NCE	2026-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213498-007	NCE	2026-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213498-008	NCE	2026-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213498-009	NCE	2026-03-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213498-010	NCE	2026-03-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213498-001	NCE	2026-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213498-002	NCE	2026-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213498-003	NCE	2026-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213498-004	NCE	2026-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213498-005	NCE	2026-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213498-006	NCE	2026-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213498-007	NCE	2026-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213498-008	NCE	2026-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213498-009	NCE	2026-03-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213498-010	NCE	2026-03-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213498-001	NCE	2026-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213498-002	NCE	2026-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213498-003	NCE	2026-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213498-004	NCE	2026-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213498-005	NCE	2026-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213498-006	NCE	2026-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213498-007	NCE	2026-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213498-008	NCE	2026-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213498-009	NCE	2026-03-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213498-010	NCE	2026-03-18	`31067a03dcf5…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PONVORY	PONESIMOD	Vanda Pharmaceuticals Inc.	0c025ba8-ba51-272e-e063-6294a90ad120	2025-12-04	Warnings, Adverse reactions	Exact identifier application applno (NDA): 213498 application number: NDA213498
PONVORY	PONESIMOD	Janssen Pharmaceuticals, Inc	5be69660-738c-4db7-b0d4-517aa873dc41	2025-04-25	Warnings, Adverse reactions	Exact identifier application applno (NDA): 213498 application number: NDA213498 ndc (product): 50458-720 ndc (product): 50458-707

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50458-707	PONVORY	Ponesimod	Janssen Pharmaceuticals, Inc	NDA	Current
50458-707	PONVORY	Ponesimod	Janssen Pharmaceuticals, Inc	NDA	Current
50458-707	PONVORY	Ponesimod	Janssen Pharmaceuticals, Inc	NDA	Current
50458-707	PONVORY	Ponesimod	Janssen Pharmaceuticals, Inc	NDA	Current
50458-720	PONVORY	Ponesimod	Janssen Pharmaceuticals, Inc	NDA	Current
50458-720	PONVORY	Ponesimod	Janssen Pharmaceuticals, Inc	NDA	Current
50458-720	PONVORY	Ponesimod	Janssen Pharmaceuticals, Inc	NDA	Current
50458-720	PONVORY	Ponesimod	Janssen Pharmaceuticals, Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78736	SUPPL	2024-07-02
78735	SUPPL	2024-07-02
78693	SUPPL	2024-06-06
78692	SUPPL	2024-06-06
78691	SUPPL	2024-06-06
75054	SUPPL	2023-08-14
75046	SUPPL	2023-08-11
69152	SUPPL	2021-10-29
69150	SUPPL	2021-10-28
69149	SUPPL	2021-10-28
67070	ORIG	2021-04-16
66817	ORIG	2021-03-19
66815	ORIG	2021-03-19
66814	ORIG	2021-03-19