Application 214985

Type: NDA
Sponsor: IDORSIA PHARMACEUTICALS LTD.

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	QUVIVIQ	DARIDOREXANT	TABLET; ORAL	25MG	No	No
002	QUVIVIQ	DARIDOREXANT	TABLET; ORAL	50MG	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
N214985-001	QUVIVIQ	DARIDOREXANT HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL		RLD	2022-04-07
N214985-002	QUVIVIQ	DARIDOREXANT HYDROCHLORIDE	EQ 50MG BASE	TABLET / ORAL		RLD, RS	2022-04-07

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
N214985-001	9732075	2033-06-03	U-620	Drug substance, Drug product	2022-05-03
N214985-001	10023560	2034-12-02	U-620		2022-05-03
N214985-001	9790208	2034-12-02		Drug substance, Drug product	2022-05-03
N214985-002	9732075	2033-06-03	U-620	Drug substance, Drug product	2022-05-03
N214985-002	10023560	2034-12-02	U-620		2022-05-03
N214985-002	9790208	2034-12-02		Drug substance, Drug product	2022-05-03

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 6 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N214985-001	NCE	2027-04-07
N214985-001	M-200	2027-09-30
N214985-001	M-310	2027-09-30
N214985-002	NCE	2027-04-07
N214985-002	M-200	2027-09-30
N214985-002	M-310	2027-09-30

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 · 64 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N214985-001	QUVIVIQ	EQ 25MG BASE	TABLET / ORAL	RLD	2022-04-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214985-002	QUVIVIQ	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-04-07	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N214985-001	QUVIVIQ	EQ 25MG BASE	TABLET / ORAL	RLD	2022-04-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214985-002	QUVIVIQ	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-04-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N214985-001	QUVIVIQ	EQ 25MG BASE	TABLET / ORAL	RLD	2022-04-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214985-002	QUVIVIQ	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-04-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214985-001	QUVIVIQ	EQ 25MG BASE	TABLET / ORAL	RLD	2022-04-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214985-002	QUVIVIQ	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-04-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214985-001	QUVIVIQ	EQ 25MG BASE	TABLET / ORAL	RLD	2022-04-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214985-002	QUVIVIQ	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-04-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214985-001	QUVIVIQ	EQ 25MG BASE	TABLET / ORAL	RLD	2022-04-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214985-002	QUVIVIQ	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-04-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214985-001	QUVIVIQ	EQ 25MG BASE	TABLET / ORAL	RLD	2022-04-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214985-002	QUVIVIQ	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-04-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214985-001	QUVIVIQ	EQ 25MG BASE	TABLET / ORAL	RLD	2022-04-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214985-002	QUVIVIQ	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-04-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214985-001	QUVIVIQ	EQ 25MG BASE	TABLET / ORAL	RLD	2022-04-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214985-002	QUVIVIQ	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-04-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214985-001	QUVIVIQ	EQ 25MG BASE	TABLET / ORAL	RLD	2022-04-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214985-002	QUVIVIQ	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-04-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214985-001	QUVIVIQ	EQ 25MG BASE	TABLET / ORAL	RLD	2022-04-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214985-002	QUVIVIQ	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-04-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214985-001	QUVIVIQ	EQ 25MG BASE	TABLET / ORAL	RLD	2022-04-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214985-002	QUVIVIQ	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-04-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214985-001	QUVIVIQ	EQ 25MG BASE	TABLET / ORAL	RLD	2022-04-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214985-002	QUVIVIQ	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-04-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214985-001	QUVIVIQ	EQ 25MG BASE	TABLET / ORAL	RLD	2022-04-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214985-002	QUVIVIQ	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-04-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214985-001	QUVIVIQ	EQ 25MG BASE	TABLET / ORAL	RLD	2022-04-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214985-002	QUVIVIQ	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-04-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214985-001	QUVIVIQ	EQ 25MG BASE	TABLET / ORAL	RLD	2022-04-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214985-002	QUVIVIQ	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-04-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214985-001	QUVIVIQ	EQ 25MG BASE	TABLET / ORAL	RLD	2022-04-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N214985-002	QUVIVIQ	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-04-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214985-001	QUVIVIQ	EQ 25MG BASE	TABLET / ORAL	RLD	2022-04-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214985-002	QUVIVIQ	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-04-07	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214985-001	QUVIVIQ	EQ 25MG BASE	TABLET / ORAL	RLD	2022-04-07	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214985-002	QUVIVIQ	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-04-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214985-001	QUVIVIQ	EQ 25MG BASE	TABLET / ORAL	RLD	2022-04-07	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N214985-002	QUVIVIQ	EQ 50MG BASE	TABLET / ORAL	RLD, RS	2022-04-07	`1c564ffb4f44…`

Observed Orange Book patent history#

Patent history page 2 of 5 · 192 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214985-002	10023560	2034-12-02	U-620		2022-05-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214985-002	9790208	2034-12-02		Drug substance, Drug product	2022-05-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214985-001	9732075	2033-06-12	U-620	Drug substance, Drug product	2022-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214985-001	10023560	2034-12-02	U-620		2022-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214985-001	9790208	2034-12-02		Drug substance, Drug product	2022-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214985-002	9732075	2033-06-12	U-620	Drug substance, Drug product	2022-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214985-002	10023560	2034-12-02	U-620		2022-05-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214985-002	9790208	2034-12-02		Drug substance, Drug product	2022-05-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214985-001	9732075	2033-06-12	U-620	Drug substance, Drug product	2022-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214985-001	10023560	2034-12-02	U-620		2022-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214985-001	9790208	2034-12-02		Drug substance, Drug product	2022-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214985-002	9732075	2033-06-12	U-620	Drug substance, Drug product	2022-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214985-002	10023560	2034-12-02	U-620		2022-05-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214985-002	9790208	2034-12-02		Drug substance, Drug product	2022-05-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214985-001	9732075	2033-06-12	U-620	Drug substance, Drug product	2022-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214985-001	10023560	2034-12-02	U-620		2022-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214985-001	9790208	2034-12-02		Drug substance, Drug product	2022-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214985-002	9732075	2033-06-12	U-620	Drug substance, Drug product	2022-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214985-002	10023560	2034-12-02	U-620		2022-05-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214985-002	9790208	2034-12-02		Drug substance, Drug product	2022-05-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214985-001	9732075	2033-06-12	U-620	Drug substance, Drug product	2022-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214985-001	10023560	2034-12-02	U-620		2022-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214985-001	9790208	2034-12-02		Drug substance, Drug product	2022-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214985-002	9732075	2033-06-12	U-620	Drug substance, Drug product	2022-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214985-002	10023560	2034-12-02	U-620		2022-05-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214985-002	9790208	2034-12-02		Drug substance, Drug product	2022-05-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214985-001	9732075	2033-06-12	U-620	Drug substance, Drug product	2022-05-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214985-001	10023560	2034-12-02	U-620		2022-05-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214985-001	9790208	2034-12-02		Drug substance, Drug product	2022-05-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214985-002	9732075	2033-06-12	U-620	Drug substance, Drug product	2022-05-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214985-002	10023560	2034-12-02	U-620		2022-05-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214985-002	9790208	2034-12-02		Drug substance, Drug product	2022-05-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214985-001	9732075	2033-06-12	U-620	Drug substance, Drug product	2022-05-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214985-001	10023560	2034-12-02	U-620		2022-05-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214985-001	9790208	2034-12-02		Drug substance, Drug product	2022-05-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214985-002	9732075	2033-06-12	U-620	Drug substance, Drug product	2022-05-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214985-002	10023560	2034-12-02	U-620		2022-05-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214985-002	9790208	2034-12-02		Drug substance, Drug product	2022-05-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214985-001	9732075	2033-06-12	U-620	Drug substance, Drug product	2022-05-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214985-001	10023560	2034-12-02	U-620		2022-05-03	`79d66fd596c7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 106 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-10-15 13:18:30	2026-09	N214985-001	NCE	2027-04-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214985-001	M-200	2027-09-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214985-001	M-310	2027-09-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214985-002	NCE	2027-04-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214985-002	M-200	2027-09-30	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N214985-002	M-310	2027-09-30	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N214985-001	NCE	2027-04-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214985-001	M-200	2027-09-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214985-001	M-310	2027-09-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214985-002	NCE	2027-04-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214985-002	M-200	2027-09-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214985-002	M-310	2027-09-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N214985-001	NCE	2027-04-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214985-001	M-200	2027-09-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214985-001	M-310	2027-09-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214985-002	NCE	2027-04-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214985-002	M-200	2027-09-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214985-002	M-310	2027-09-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214985-001	NCE	2027-04-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214985-001	M-200	2027-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214985-001	M-310	2027-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214985-002	NCE	2027-04-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214985-002	M-200	2027-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214985-002	M-310	2027-09-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214985-001	NCE	2027-04-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214985-001	M-200	2027-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214985-001	M-310	2027-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214985-002	NCE	2027-04-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214985-002	M-200	2027-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214985-002	M-310	2027-09-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214985-001	NCE	2027-04-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214985-001	M-200	2027-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214985-001	M-310	2027-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214985-002	NCE	2027-04-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214985-002	M-200	2027-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214985-002	M-310	2027-09-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214985-001	NCE	2027-04-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214985-001	M-200	2027-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214985-001	M-310	2027-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214985-002	NCE	2027-04-07	`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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
QUVIVIQ	DARIDOREXANT	Idorsia Pharmaceuticals Ltd	3a2d1503-b816-40c9-9fac-7e03c5a3bcef	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214985 application number: NDA214985 ndc (product): 80491-7825 ndc (product): 80491-7850

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
80491-7825	QUVIVIQ	Daridorexant	Idorsia Pharmaceuticals Ltd	NDA	Current
80491-7825	QUVIVIQ	Daridorexant	Idorsia Pharmaceuticals Ltd	NDA	Current
80491-7850	QUVIVIQ	Daridorexant	Idorsia Pharmaceuticals Ltd	NDA	Current
80491-7850	QUVIVIQ	Daridorexant	Idorsia Pharmaceuticals Ltd	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79797	SUPPL	2024-10-01
79796	SUPPL	2024-10-01
79795	SUPPL	2024-10-01
79792	SUPPL	2024-10-01
79791	SUPPL	2024-10-01
79790	SUPPL	2024-10-01
79788	SUPPL	2024-10-01
76741	SUPPL	2023-12-06
76010	SUPPL	2023-10-31
76009	SUPPL	2023-10-31
75994	SUPPL	2023-10-31
75993	SUPPL	2023-10-31
72589	SUPPL	2022-11-10
72588	SUPPL	2022-11-10
72583	SUPPL	2022-11-09
71542	ORIG	2022-07-13
70155	ORIG	2022-02-14
69833	ORIG	2022-01-11
69832	ORIG	2022-01-11
69829	ORIG	2022-01-11