Application 204569

Type: NDA
Sponsor: MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BELSOMRA	SUVOREXANT	TABLET;ORAL	5MG	Yes	No
002	BELSOMRA	SUVOREXANT	TABLET;ORAL	10MG	Yes	No
003	BELSOMRA	SUVOREXANT	TABLET;ORAL	15MG	Yes	No
004	BELSOMRA	SUVOREXANT	TABLET;ORAL	20MG	Yes	Yes

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N204569-001	BELSOMRA	SUVOREXANT	5MG	TABLET / ORAL	RLD	2014-08-13
N204569-002	BELSOMRA	SUVOREXANT	10MG	TABLET / ORAL	RLD	2014-08-13
N204569-003	BELSOMRA	SUVOREXANT	15MG	TABLET / ORAL	RLD	2014-08-13
N204569-004	BELSOMRA	SUVOREXANT	20MG	TABLET / ORAL	RLD, RS	2014-08-13

Orange Book patents#

Current patent rows page 1 of 1 · 16 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N204569-001	7951797	2029-11-20	U-620	Drug substance, Drug product	2014-09-10
N204569-001	10098892	2033-05-29		Drug product	2018-10-17
N204569-001	11980623	2033-05-29		Drug product	2024-05-20
N204569-001	12599610	2033-05-29		Drug product	2026-06-17
N204569-002	7951797	2029-11-20	U-620	Drug substance, Drug product	2014-09-10
N204569-002	10098892	2033-05-29		Drug product	2018-10-17
N204569-002	11980623	2033-05-29		Drug product	2024-05-20
N204569-002	12599610	2033-05-29		Drug product	2026-06-17
N204569-003	7951797	2029-11-20	U-620	Drug substance, Drug product	2014-09-10
N204569-003	10098892	2033-05-29		Drug product	2018-10-17
N204569-003	11980623	2033-05-29		Drug product	2024-05-20
N204569-003	12599610	2033-05-29		Drug product	2026-06-17
N204569-004	7951797	2029-11-20	U-620	Drug substance, Drug product	2014-09-10
N204569-004	10098892	2033-05-29		Drug product	2018-10-17
N204569-004	11980623	2033-05-29		Drug product	2024-05-20
N204569-004	12599610	2033-05-29		Drug product	2026-06-17

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 5 · 164 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	N204569-001	BELSOMRA	5MG	TABLET / ORAL	RLD	2014-08-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204569-002	BELSOMRA	10MG	TABLET / ORAL	RLD	2014-08-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204569-003	BELSOMRA	15MG	TABLET / ORAL	RLD	2014-08-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204569-004	BELSOMRA	20MG	TABLET / ORAL	RLD, RS	2014-08-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204569-001	BELSOMRA	5MG	TABLET / ORAL	RLD	2014-08-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204569-002	BELSOMRA	10MG	TABLET / ORAL	RLD	2014-08-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204569-003	BELSOMRA	15MG	TABLET / ORAL	RLD	2014-08-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204569-004	BELSOMRA	20MG	TABLET / ORAL	RLD, RS	2014-08-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204569-001	BELSOMRA	5MG	TABLET / ORAL	RLD	2014-08-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204569-002	BELSOMRA	10MG	TABLET / ORAL	RLD	2014-08-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204569-003	BELSOMRA	15MG	TABLET / ORAL	RLD	2014-08-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204569-004	BELSOMRA	20MG	TABLET / ORAL	RLD, RS	2014-08-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204569-001	BELSOMRA	5MG	TABLET / ORAL	RLD	2014-08-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204569-002	BELSOMRA	10MG	TABLET / ORAL	RLD	2014-08-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204569-003	BELSOMRA	15MG	TABLET / ORAL	RLD	2014-08-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204569-004	BELSOMRA	20MG	TABLET / ORAL	RLD, RS	2014-08-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204569-001	BELSOMRA	5MG	TABLET / ORAL	RLD	2014-08-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204569-002	BELSOMRA	10MG	TABLET / ORAL	RLD	2014-08-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204569-003	BELSOMRA	15MG	TABLET / ORAL	RLD	2014-08-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204569-004	BELSOMRA	20MG	TABLET / ORAL	RLD, RS	2014-08-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204569-001	BELSOMRA	5MG	TABLET / ORAL	RLD	2014-08-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204569-002	BELSOMRA	10MG	TABLET / ORAL	RLD	2014-08-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204569-003	BELSOMRA	15MG	TABLET / ORAL	RLD	2014-08-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204569-004	BELSOMRA	20MG	TABLET / ORAL	RLD, RS	2014-08-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204569-001	BELSOMRA	5MG	TABLET / ORAL	RLD	2014-08-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204569-002	BELSOMRA	10MG	TABLET / ORAL	RLD	2014-08-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204569-003	BELSOMRA	15MG	TABLET / ORAL	RLD	2014-08-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204569-004	BELSOMRA	20MG	TABLET / ORAL	RLD, RS	2014-08-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204569-001	BELSOMRA	5MG	TABLET / ORAL	RLD	2014-08-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204569-002	BELSOMRA	10MG	TABLET / ORAL	RLD	2014-08-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204569-003	BELSOMRA	15MG	TABLET / ORAL	RLD	2014-08-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204569-004	BELSOMRA	20MG	TABLET / ORAL	RLD, RS	2014-08-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204569-001	BELSOMRA	5MG	TABLET / ORAL	RLD	2014-08-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204569-002	BELSOMRA	10MG	TABLET / ORAL	RLD	2014-08-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204569-003	BELSOMRA	15MG	TABLET / ORAL	RLD	2014-08-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204569-004	BELSOMRA	20MG	TABLET / ORAL	RLD, RS	2014-08-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204569-001	BELSOMRA	5MG	TABLET / ORAL	RLD	2014-08-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204569-002	BELSOMRA	10MG	TABLET / ORAL	RLD	2014-08-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204569-003	BELSOMRA	15MG	TABLET / ORAL	RLD	2014-08-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204569-004	BELSOMRA	20MG	TABLET / ORAL	RLD, RS	2014-08-13	`d06236e962d9…`

Observed Orange Book patent history#

Patent history page 1 of 10 · 388 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	N204569-001	7951797	2029-11-20	U-620	Drug substance, Drug product	2014-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204569-001	10098892	2033-05-29		Drug product	2018-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204569-001	11980623	2033-05-29		Drug product	2024-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204569-002	7951797	2029-11-20	U-620	Drug substance, Drug product	2014-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204569-002	10098892	2033-05-29		Drug product	2018-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204569-002	11980623	2033-05-29		Drug product	2024-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204569-003	7951797	2029-11-20	U-620	Drug substance, Drug product	2014-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204569-003	10098892	2033-05-29		Drug product	2018-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204569-003	11980623	2033-05-29		Drug product	2024-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204569-004	7951797	2029-11-20	U-620	Drug substance, Drug product	2014-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204569-004	10098892	2033-05-29		Drug product	2018-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204569-004	11980623	2033-05-29		Drug product	2024-05-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204569-001	7951797	2029-11-20	U-620	Drug substance, Drug product	2014-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204569-001	10098892	2033-05-29		Drug product	2018-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204569-001	11980623	2033-05-29		Drug product	2024-05-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204569-002	7951797	2029-11-20	U-620	Drug substance, Drug product	2014-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204569-002	10098892	2033-05-29		Drug product	2018-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204569-002	11980623	2033-05-29		Drug product	2024-05-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204569-003	7951797	2029-11-20	U-620	Drug substance, Drug product	2014-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204569-003	10098892	2033-05-29		Drug product	2018-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204569-003	11980623	2033-05-29		Drug product	2024-05-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204569-004	7951797	2029-11-20	U-620	Drug substance, Drug product	2014-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204569-004	10098892	2033-05-29		Drug product	2018-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204569-004	11980623	2033-05-29		Drug product	2024-05-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204569-001	7951797	2029-11-20	U-620	Drug substance, Drug product	2014-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204569-001	10098892	2033-05-29		Drug product	2018-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204569-001	11980623	2033-05-29		Drug product	2024-05-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204569-002	7951797	2029-11-20	U-620	Drug substance, Drug product	2014-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204569-002	10098892	2033-05-29		Drug product	2018-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204569-002	11980623	2033-05-29		Drug product	2024-05-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204569-003	7951797	2029-11-20	U-620	Drug substance, Drug product	2014-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204569-003	10098892	2033-05-29		Drug product	2018-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204569-003	11980623	2033-05-29		Drug product	2024-05-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204569-004	7951797	2029-11-20	U-620	Drug substance, Drug product	2014-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204569-004	10098892	2033-05-29		Drug product	2018-10-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204569-004	11980623	2033-05-29		Drug product	2024-05-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204569-001	7951797	2029-11-20	U-620	Drug substance, Drug product	2014-09-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204569-001	10098892	2033-05-29		Drug product	2018-10-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204569-001	11980623	2033-05-29		Drug product	2024-05-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204569-002	7951797	2029-11-20	U-620	Drug substance, Drug product	2014-09-10	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 96 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204569-001	M-253	2023-01-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204569-002	M-253	2023-01-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204569-003	M-253	2023-01-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204569-004	M-253	2023-01-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204569-001	M-253	2023-01-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N204569-002	M-253	2023-01-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N204569-003	M-253	2023-01-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N204569-004	M-253	2023-01-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204569-001	M-253	2023-01-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N204569-002	M-253	2023-01-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N204569-003	M-253	2023-01-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N204569-004	M-253	2023-01-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204569-001	NCE	2019-08-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204569-002	NCE	2019-08-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204569-003	NCE	2019-08-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204569-004	NCE	2019-08-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204569-001	M-253	2023-01-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N204569-002	M-253	2023-01-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N204569-003	M-253	2023-01-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N204569-004	M-253	2023-01-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204569-001	M-253	2023-01-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N204569-002	M-253	2023-01-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N204569-003	M-253	2023-01-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N204569-004	M-253	2023-01-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204569-001	M-253	2023-01-29	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204569-002	M-253	2023-01-29	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204569-003	M-253	2023-01-29	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N204569-004	M-253	2023-01-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N204569-001	M-253	2023-01-29	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N204569-002	M-253	2023-01-29	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N204569-003	M-253	2023-01-29	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N204569-004	M-253	2023-01-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N204569-001	M-253	2023-01-29	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N204569-002	M-253	2023-01-29	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N204569-003	M-253	2023-01-29	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N204569-004	M-253	2023-01-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N204569-001	M-253	2023-01-29	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N204569-002	M-253	2023-01-29	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N204569-003	M-253	2023-01-29	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N204569-004	M-253	2023-01-29	`c0c555d07b60…`

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
BELSOMRA	SUVOREXANT	Merck Sharp & Dohme LLC	e5b72731-1acb-45b7-9c13-290ad12d3951	2025-03-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 204569 application number: NDA204569 ndc (product): 0006-0005 ndc (product): 0006-0325 ndc (product): 0006-0335 ndc (product): 0006-0033

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0006-0005	BELSOMRA	suvorexant	Merck Sharp & Dohme Corp.	NDA	Current
0006-0005	BELSOMRA	suvorexant	Merck Sharp & Dohme Corp.	NDA	Current
0006-0005	BELSOMRA	suvorexant	Merck Sharp & Dohme Corp.	NDA	Current
0006-0005	BELSOMRA	suvorexant	Merck Sharp & Dohme LLC	NDA	Current
0006-0005	BELSOMRA	suvorexant	Merck Sharp & Dohme Corp.	NDA	Current
0006-0005	BELSOMRA	suvorexant	Merck Sharp & Dohme Corp.	NDA	Current
0006-0005	BELSOMRA	suvorexant	Merck Sharp & Dohme Corp.	NDA	Current
0006-0033	BELSOMRA	suvorexant	Merck Sharp & Dohme Corp.	NDA	Current
0006-0033	BELSOMRA	suvorexant	Merck Sharp & Dohme Corp.	NDA	Current
0006-0033	BELSOMRA	suvorexant	Merck Sharp & Dohme Corp.	NDA	Current
0006-0033	BELSOMRA	suvorexant	Merck Sharp & Dohme LLC	NDA	Current
0006-0033	BELSOMRA	suvorexant	Merck Sharp & Dohme Corp.	NDA	Current
0006-0033	BELSOMRA	suvorexant	Merck Sharp & Dohme Corp.	NDA	Current
0006-0033	BELSOMRA	suvorexant	Merck Sharp & Dohme Corp.	NDA	Current
0006-0325	BELSOMRA	suvorexant	Merck Sharp & Dohme Corp.	NDA	Current
0006-0325	BELSOMRA	suvorexant	Merck Sharp & Dohme Corp.	NDA	Current
0006-0325	BELSOMRA	suvorexant	Merck Sharp & Dohme Corp.	NDA	Current
0006-0325	BELSOMRA	suvorexant	Merck Sharp & Dohme LLC	NDA	Current
0006-0325	BELSOMRA	suvorexant	Merck Sharp & Dohme Corp.	NDA	Current
0006-0325	BELSOMRA	suvorexant	Merck Sharp & Dohme Corp.	NDA	Current
0006-0325	BELSOMRA	suvorexant	Merck Sharp & Dohme Corp.	NDA	Current
0006-0335	BELSOMRA	suvorexant	Merck Sharp & Dohme Corp.	NDA	Current
0006-0335	BELSOMRA	suvorexant	Merck Sharp & Dohme Corp.	NDA	Current
0006-0335	BELSOMRA	suvorexant	Merck Sharp & Dohme Corp.	NDA	Current
0006-0335	BELSOMRA	suvorexant	Merck Sharp & Dohme LLC	NDA	Current
0006-0335	BELSOMRA	suvorexant	Merck Sharp & Dohme Corp.	NDA	Current
0006-0335	BELSOMRA	suvorexant	Merck Sharp & Dohme Corp.	NDA	Current
0006-0335	BELSOMRA	suvorexant	Merck Sharp & Dohme Corp.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81539	SUPPL	2025-03-12
81531	SUPPL	2025-03-11
81530	SUPPL	2025-03-11
66897	SUPPL	2021-03-29
66896	SUPPL	2021-03-26
66895	SUPPL	2021-03-26
62191	SUPPL	2020-03-20
62190	SUPPL	2020-03-20
62205	SUPPL	2020-03-19
61743	SUPPL	2020-02-03
61749	SUPPL	2020-01-31
61748	SUPPL	2020-01-31
54896	SUPPL	2018-07-16
54882	SUPPL	2018-07-13
54881	SUPPL	2018-07-13
10356	SUPPL	2016-05-31
10355	SUPPL	2014-11-12
19571	SUPPL	2014-11-10
44905	ORIG	2014-09-12
43468	ORIG	2014-09-12
32568	ORIG	2014-08-14
19570	ORIG	2014-08-14