Application 211243

Type: NDA
Sponsor: JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SPRAVATO	ESKETAMINE HYDROCHLORIDE	SPRAY;NASAL	EQ 28MG BASE	Yes	Yes

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

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
N211243-001	SPRAVATO	ESKETAMINE HYDROCHLORIDE	EQ 28MG BASE	SPRAY / NASAL		RLD, RS	2019-03-05

Orange Book patents#

Current patent rows page 1 of 1 · 25 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N211243-001	9592207	2027-03-20	U-2502	2019-04-03
N211243-001	9592207	2027-03-20	U-4112	2019-04-03
N211243-001	8785500	2033-03-05	U-2502	2019-04-03
N211243-001	8785500	2033-03-05	U-4112	2019-04-03
N211243-001	11446260	2034-03-14	U-3444	2022-10-14
N211243-001	11446260	2034-03-14	U-3445	2022-10-14
N211243-001	11446260	2034-03-14	U-3446	2022-10-14
N211243-001	11446260	2034-03-14	U-4118	2022-10-14
N211243-001	11446260	2034-03-14	U-4119	2022-10-14
N211243-001	10869844	2035-09-10	U-3034	2021-01-15
N211243-001	10869844	2035-09-10	U-3035	2021-01-15
N211243-001	10869844	2035-09-10	U-3036	2021-01-15
N211243-001	10869844	2035-09-10	U-4113	2021-01-15
N211243-001	10869844	2035-09-10	U-4114	2021-01-15
N211243-001	11173134	2035-09-10	U-3257	2021-12-16
N211243-001	11173134	2035-09-10	U-3536	2021-12-16
N211243-001	11173134	2035-09-10	U-4115	2021-12-16
N211243-001	11311500	2035-09-10	U-3034	2022-05-26
N211243-001	11311500	2035-09-10	U-3035	2022-05-26
N211243-001	11311500	2035-09-10	U-3036	2022-05-26
N211243-001	11311500	2035-09-10	U-4116	2022-05-26
N211243-001	11311500	2035-09-10	U-4117	2022-05-26
N211243-001	11883526	2040-02-18	U-3812	2024-02-16
N211243-001	11883526	2040-02-18	U-3813	2024-02-16
N211243-001	11883526	2040-02-18	U-4120	2024-02-16

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N211243-001	I-959	2028-01-17

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 2 · 43 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	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N211243-001	SPRAVATO	EQ 28MG BASE	SPRAY / NASAL	RLD, RS	2019-03-05	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 14 · 546 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N211243-001	9592207	2027-03-20	U-2502	2019-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	9592207	2027-03-20	U-4112	2019-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	8785500	2033-03-05	U-2502	2019-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	8785500	2033-03-05	U-4112	2019-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	11446260	2034-03-14	U-4118	2022-10-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	11446260	2034-03-14	U-4119	2022-10-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	11446260	2034-03-14	U-3444	2022-10-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	11446260	2034-03-14	U-3445	2022-10-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	11446260	2034-03-14	U-3446	2022-10-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	10869844	2035-09-10	U-4113	2021-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	10869844	2035-09-10	U-4114	2021-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	10869844	2035-09-10	U-3035	2021-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	10869844	2035-09-10	U-3034	2021-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	10869844	2035-09-10	U-3036	2021-01-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	11173134	2035-09-10	U-4115	2021-12-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	11173134	2035-09-10	U-3536	2021-12-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	11173134	2035-09-10	U-3257	2021-12-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	11311500	2035-09-10	U-4116	2022-05-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	11311500	2035-09-10	U-4117	2022-05-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	11311500	2035-09-10	U-3034	2022-05-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	11311500	2035-09-10	U-3036	2022-05-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	11311500	2035-09-10	U-3035	2022-05-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	11883526	2040-02-18	U-4120	2024-02-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	11883526	2040-02-18	U-3812	2024-02-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N211243-001	11883526	2040-02-18	U-3813	2024-02-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N211243-001	9592207	2027-03-20	U-2502	2019-04-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211243-001	9592207	2027-03-20	U-4112	2019-04-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211243-001	8785500	2033-03-05	U-2502	2019-04-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211243-001	8785500	2033-03-05	U-4112	2019-04-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211243-001	11446260	2034-03-14	U-4118	2022-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211243-001	11446260	2034-03-14	U-4119	2022-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211243-001	11446260	2034-03-14	U-3444	2022-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211243-001	11446260	2034-03-14	U-3445	2022-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211243-001	11446260	2034-03-14	U-3446	2022-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211243-001	10869844	2035-09-10	U-4113	2021-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211243-001	10869844	2035-09-10	U-4114	2021-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211243-001	10869844	2035-09-10	U-3035	2021-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211243-001	10869844	2035-09-10	U-3034	2021-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211243-001	10869844	2035-09-10	U-3036	2021-01-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211243-001	11173134	2035-09-10	U-4115	2021-12-16	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 62 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	N211243-001	I-959	2028-01-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N211243-001	I-959	2028-01-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211243-001	I-959	2028-01-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211243-001	I-959	2028-01-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211243-001	I-959	2028-01-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211243-001	I-959	2028-01-17	`fd3edfee7708…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211243-001	NCE*	2024-03-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211243-001	NCE*	2024-03-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211243-001	NCE*	2024-03-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211243-001	NCE*	2024-03-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211243-001	NCE*	2024-03-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211243-001	NCE*	2024-03-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211243-001	NCE*	2024-03-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211243-001	NCE*	2024-03-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211243-001	NCE*	2024-03-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211243-001	I-840	2023-07-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211243-001	NCE*	2024-03-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211243-001	I-840	2023-07-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N211243-001	NCE*	2024-03-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211243-001	I-840	2023-07-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N211243-001	NCE*	2024-03-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N211243-001	NCE*	2024-03-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N211243-001	I-840	2023-07-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N211243-001	NCE*	2024-03-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N211243-001	I-840	2023-07-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N211243-001	NCE*	2024-03-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211243-001	I-840	2023-07-31	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N211243-001	NCE*	2024-03-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N211243-001	I-840	2023-07-31	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N211243-001	NCE*	2024-03-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N211243-001	I-840	2023-07-31	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N211243-001	NCE*	2024-03-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N211243-001	I-840	2023-07-31	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N211243-001	NCE*	2024-03-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N211243-001	NCE*	2024-03-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N211243-001	NCE*	2024-03-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N211243-001	NCE*	2024-03-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N211243-001	NCE*	2024-03-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N211243-001	NCE*	2024-03-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N211243-001	I-840	2023-07-31	`ea1830bbd6c7…`

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
Spravato	ESKETAMINE HYDROCHLORIDE	Janssen Pharmaceuticals, Inc.	d81a6a79-a74a-44b7-822c-0dfa3036eaed	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 211243 application number: NDA211243 ndc (product): 50458-028

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50458-028	Spravato	Esketamine Hydrochloride	Janssen Pharmaceuticals Inc.	NDA	Current
50458-028	Spravato	Esketamine Hydrochloride	Janssen Pharmaceuticals Inc.	NDA	Current
50458-028	Spravato	Esketamine Hydrochloride	Janssen Pharmaceuticals Inc.	NDA	Current
50458-028	Spravato	Esketamine Hydrochloride	Janssen Pharmaceuticals Inc.	NDA	Current
50458-028	Spravato	Esketamine Hydrochloride	Janssen Pharmaceuticals Inc.	NDA	Current
50458-028	Spravato	Esketamine Hydrochloride	Janssen Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85729	SUPPL	2026-04-21
84831	SUPPL	2026-01-26
83724	SUPPL	2025-10-10
83018	SUPPL	2025-08-01
82200	SUPPL	2025-05-19
82124	SUPPL	2025-05-01
82041	SUPPL	2025-04-29
82040	SUPPL	2025-04-29
81764	SUPPL	2025-03-28
80902	SUPPL	2025-02-04
80895	SUPPL	2025-02-04
80805	SUPPL	2025-01-02
80174	SUPPL	2024-11-05
80151	SUPPL	2024-11-05
75861	SUPPL	2023-10-19
75847	SUPPL	2023-10-19
73287	SUPPL	2023-01-25
72841	SUPPL	2022-12-09
69814	SUPPL	2022-01-05
64192	SUPPL	2020-08-03
64191	SUPPL	2020-08-03
64179	SUPPL	2020-08-03
61874	SUPPL	2020-02-12
61873	SUPPL	2020-02-12
61869	SUPPL	2020-02-12
59219	ORIG	2019-07-02
59174	SUPPL	2019-06-26
58642	SUPPL	2019-05-13
58637	SUPPL	2019-05-10
58636	SUPPL	2019-05-10
58220	ORIG	2019-04-05
57911	ORIG	2019-03-06
57910	ORIG	2019-03-06
57909	ORIG	2019-03-06