Application 211635

Type: NDA
Sponsor: NEURELIS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VALTOCO	DIAZEPAM	SPRAY;NASAL	5MG/SPRAY	Yes	No
002	VALTOCO	DIAZEPAM	SPRAY;NASAL	7.5MG/SPRAY	Yes	No
003	VALTOCO	DIAZEPAM	SPRAY;NASAL	10MG/SPRAY	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N211635-001	VALTOCO	DIAZEPAM	5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10
N211635-002	VALTOCO	DIAZEPAM	7.5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10
N211635-003	VALTOCO	DIAZEPAM	10MG/SPRAY	SPRAY / NASAL	RLD, RS	2020-01-10

Orange Book patents#

Current patent rows page 1 of 1 · 24 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N211635-001	11241414	2029-03-27		Drug product	2022-03-01
N211635-001	11793786	2029-03-27		Drug product	2023-10-31
N211635-001	12268664	2029-03-27		Drug product	2025-04-09
N211635-001	12521400	2029-03-27		Drug product	2026-01-15
N211635-001	8895546	2029-03-27		Drug product	2020-02-06
N211635-001	12337061	2032-06-13	U-4173		2025-06-27
N211635-001	12324852	2032-10-16	U-4173		2025-06-27
N211635-001	12599611	2042-06-10	U-4455		2026-04-20
N211635-002	11241414	2029-03-27		Drug product	2022-03-01
N211635-002	11793786	2029-03-27		Drug product	2023-10-31
N211635-002	12268664	2029-03-27		Drug product	2025-04-09
N211635-002	12521400	2029-03-27		Drug product	2026-01-15
N211635-002	8895546	2029-03-27		Drug product	2020-02-06
N211635-002	12337061	2032-06-13	U-4173		2025-06-27
N211635-002	12324852	2032-10-16	U-4173		2025-06-27
N211635-002	12599611	2042-06-10	U-4455		2026-04-20
N211635-003	11241414	2029-03-27		Drug product	2022-03-01
N211635-003	11793786	2029-03-27		Drug product	2023-10-31
N211635-003	12268664	2029-03-27		Drug product	2025-04-09
N211635-003	12521400	2029-03-27		Drug product	2026-01-15
N211635-003	8895546	2029-03-27		Drug product	2020-02-06
N211635-003	12337061	2032-06-13	U-4173		2025-06-27
N211635-003	12324852	2032-10-16	U-4173		2025-06-27
N211635-003	12599611	2042-06-10	U-4455		2026-04-20

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N211635-001	ODE-279	2027-01-10
N211635-001	NPP	2028-04-15
N211635-002	ODE-279	2027-01-10
N211635-002	NPP	2028-04-15
N211635-003	ODE-279	2027-01-10
N211635-003	NPP	2028-04-15

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 3 · 117 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	N211635-001	VALTOCO	5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-002	VALTOCO	7.5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-003	VALTOCO	10MG/SPRAY	SPRAY / NASAL	RLD, RS	2020-01-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N211635-001	VALTOCO	5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211635-002	VALTOCO	7.5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211635-003	VALTOCO	10MG/SPRAY	SPRAY / NASAL	RLD, RS	2020-01-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211635-001	VALTOCO	5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211635-002	VALTOCO	7.5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211635-003	VALTOCO	10MG/SPRAY	SPRAY / NASAL	RLD, RS	2020-01-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211635-001	VALTOCO	5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211635-002	VALTOCO	7.5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211635-003	VALTOCO	10MG/SPRAY	SPRAY / NASAL	RLD, RS	2020-01-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211635-001	VALTOCO	5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211635-002	VALTOCO	7.5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211635-003	VALTOCO	10MG/SPRAY	SPRAY / NASAL	RLD, RS	2020-01-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211635-001	VALTOCO	5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211635-002	VALTOCO	7.5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211635-003	VALTOCO	10MG/SPRAY	SPRAY / NASAL	RLD, RS	2020-01-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211635-001	VALTOCO	5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211635-002	VALTOCO	7.5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211635-003	VALTOCO	10MG/SPRAY	SPRAY / NASAL	RLD, RS	2020-01-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211635-001	VALTOCO	5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211635-002	VALTOCO	7.5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211635-003	VALTOCO	10MG/SPRAY	SPRAY / NASAL	RLD, RS	2020-01-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211635-001	VALTOCO	5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211635-002	VALTOCO	7.5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211635-003	VALTOCO	10MG/SPRAY	SPRAY / NASAL	RLD, RS	2020-01-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211635-001	VALTOCO	5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211635-002	VALTOCO	7.5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211635-003	VALTOCO	10MG/SPRAY	SPRAY / NASAL	RLD, RS	2020-01-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211635-001	VALTOCO	5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211635-002	VALTOCO	7.5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211635-003	VALTOCO	10MG/SPRAY	SPRAY / NASAL	RLD, RS	2020-01-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211635-001	VALTOCO	5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211635-002	VALTOCO	7.5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211635-003	VALTOCO	10MG/SPRAY	SPRAY / NASAL	RLD, RS	2020-01-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211635-001	VALTOCO	5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211635-002	VALTOCO	7.5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211635-003	VALTOCO	10MG/SPRAY	SPRAY / NASAL	RLD, RS	2020-01-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211635-001	VALTOCO	5MG/SPRAY	SPRAY / NASAL	RLD	2020-01-10	`301d65b070ca…`

Observed Orange Book patent history#

Patent history page 1 of 18 · 684 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	N211635-001	11241414	2029-03-27		Drug product	2022-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-001	11793786	2029-03-27		Drug product	2023-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-001	12268664	2029-03-27		Drug product	2025-04-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-001	12521400	2029-03-27		Drug product	2026-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-001	8895546	2029-03-27		Drug product	2020-02-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-001	12337061	2032-06-13	U-4173		2025-06-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-001	12324852	2032-10-16	U-4173		2025-06-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-001	12599611	2042-06-10	U-4455		2026-04-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-002	11241414	2029-03-27		Drug product	2022-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-002	11793786	2029-03-27		Drug product	2023-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-002	12268664	2029-03-27		Drug product	2025-04-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-002	12521400	2029-03-27		Drug product	2026-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-002	8895546	2029-03-27		Drug product	2020-02-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-002	12337061	2032-06-13	U-4173		2025-06-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-002	12324852	2032-10-16	U-4173		2025-06-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-002	12599611	2042-06-10	U-4455		2026-04-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-003	11241414	2029-03-27		Drug product	2022-03-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-003	11793786	2029-03-27		Drug product	2023-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-003	12268664	2029-03-27		Drug product	2025-04-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-003	12521400	2029-03-27		Drug product	2026-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-003	8895546	2029-03-27		Drug product	2020-02-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-003	12337061	2032-06-13	U-4173		2025-06-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-003	12324852	2032-10-16	U-4173		2025-06-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211635-003	12599611	2042-06-10	U-4455		2026-04-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N211635-001	11241414	2029-03-27		Drug product	2022-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211635-001	11793786	2029-03-27		Drug product	2023-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211635-001	12268664	2029-03-27		Drug product	2025-04-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211635-001	12521400	2029-03-27		Drug product	2026-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211635-001	8895546	2029-03-27		Drug product	2020-02-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211635-001	12337061	2032-06-13	U-4173		2025-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211635-001	12324852	2032-10-16	U-4173		2025-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211635-001	12599611	2042-06-10	U-4455		2026-04-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211635-002	11241414	2029-03-27		Drug product	2022-03-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211635-002	11793786	2029-03-27		Drug product	2023-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211635-002	12268664	2029-03-27		Drug product	2025-04-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211635-002	12521400	2029-03-27		Drug product	2026-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211635-002	8895546	2029-03-27		Drug product	2020-02-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211635-002	12337061	2032-06-13	U-4173		2025-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211635-002	12324852	2032-10-16	U-4173		2025-06-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211635-002	12599611	2042-06-10	U-4455		2026-04-20	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 4 of 5 · 195 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2024-02-18 07:12 UTC	2024-02	N211635-001	ODE-279	2027-01-10	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N211635-002	ODE-279	2027-01-10	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N211635-003	ODE-279	2027-01-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211635-001	NP	2023-01-10	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N211635-001	ODE-279	2027-01-10	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N211635-002	NP	2023-01-10	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N211635-002	ODE-279	2027-01-10	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N211635-003	NP	2023-01-10	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N211635-003	ODE-279	2027-01-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211635-001	NP	2023-01-10	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211635-001	ODE-279	2027-01-10	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211635-002	NP	2023-01-10	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211635-002	ODE-279	2027-01-10	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211635-003	NP	2023-01-10	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211635-003	ODE-279	2027-01-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211635-001	NP	2023-01-10	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211635-001	ODE-279	2027-01-10	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211635-002	NP	2023-01-10	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211635-002	ODE-279	2027-01-10	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211635-003	NP	2023-01-10	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211635-003	ODE-279	2027-01-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211635-001	NP	2023-01-10	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211635-001	ODE-279	2027-01-10	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211635-002	NP	2023-01-10	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211635-002	ODE-279	2027-01-10	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211635-003	NP	2023-01-10	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211635-003	ODE-279	2027-01-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211635-001	NP	2023-01-10	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211635-001	ODE-279	2027-01-10	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211635-002	NP	2023-01-10	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211635-002	ODE-279	2027-01-10	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211635-003	NP	2023-01-10	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211635-003	ODE-279	2027-01-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N211635-001	NP	2023-01-10	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N211635-001	ODE-279	2027-01-10	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N211635-002	NP	2023-01-10	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N211635-002	ODE-279	2027-01-10	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N211635-003	NP	2023-01-10	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N211635-003	ODE-279	2027-01-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N211635-001	NP	2023-01-10	`3bdfa0b2c4d7…`

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
Valtoco	DIAZEPAM	Neurelis, Inc	1a8bcc90-68fa-474d-832c-0df01e825f39	2026-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 211635 application number: NDA211635 ndc (product): 72252-510 ndc (product): 72252-505 ndc (product): 72252-515 ndc (product): 72252-520

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 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
72252-505	Valtoco	diazepam	Neurelis, Inc	NDA	Current
72252-505	Valtoco	diazepam	Neurelis, Inc	NDA	Current
72252-505	Valtoco	diazepam	Neurelis, Inc	NDA	Current
72252-505	Valtoco	diazepam	Neurelis, Inc	NDA	Current
72252-510	Valtoco	diazepam	Neurelis, Inc	NDA	Current
72252-510	Valtoco	diazepam	Neurelis, Inc	NDA	Current
72252-510	Valtoco	diazepam	Neurelis, Inc	NDA	Current
72252-510	Valtoco	diazepam	Neurelis, Inc	NDA	Current
72252-515	Valtoco	diazepam	Neurelis, Inc	NDA	Current
72252-515	Valtoco	diazepam	Neurelis, Inc	NDA	Current
72252-515	Valtoco	diazepam	Neurelis, Inc	NDA	Current
72252-515	Valtoco	diazepam	Neurelis, Inc	NDA	Current
72252-520	Valtoco	diazepam	Neurelis, Inc	NDA	Current
72252-520	Valtoco	diazepam	Neurelis, Inc	NDA	Current
72252-520	Valtoco	diazepam	Neurelis, Inc	NDA	Current
72252-520	Valtoco	diazepam	Neurelis, Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83289	SUPPL	2025-10-27
83288	SUPPL	2025-10-27
82005	SUPPL	2025-04-25
80656	SUPPL	2025-04-21
73213	SUPPL	2023-01-17
73212	SUPPL	2023-01-17
73187	SUPPL	2023-01-17
70126	SUPPL	2022-02-08
70125	SUPPL	2022-02-08
70112	SUPPL	2022-02-08
66159	SUPPL	2021-02-09
66158	SUPPL	2021-02-09
66143	SUPPL	2021-02-09
64552	ORIG	2020-09-10
61558	ORIG	2020-01-14
61556	ORIG	2020-01-13
61555	ORIG	2020-01-13