Application 211230

Type: NDA
Sponsor: JAZZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SUNOSI	SOLRIAMFETOL HYDROCHLORIDE	TABLET;ORAL	EQ 75MG BASE	Yes	No
002	SUNOSI	SOLRIAMFETOL HYDROCHLORIDE	TABLET;ORAL	EQ 150MG BASE	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N211230-001	SUNOSI	SOLRIAMFETOL HYDROCHLORIDE	EQ 75MG BASE	TABLET / ORAL	AB	RLD	2019-06-17
N211230-002	SUNOSI	SOLRIAMFETOL HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	RLD, RS	2019-06-17

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N211230-001	AB
N211230-002	AB

Orange Book patents#

Current patent rows page 1 of 2 · 81 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N211230-001	10351517	2026-06-07	U-2548		2019-08-16
N211230-001	11753368	2026-06-07	U-2548		2023-09-14
N211230-001	12209059	2026-06-07	U-2548		2025-02-07
N211230-001	8877806	2026-06-07	U-2548		2019-06-24
N211230-001	9604917	2026-06-07	U-2548		2019-06-24
N211230-001	8440715	2031-06-11	U-2548		2019-06-24
N211230-001	10195151	2037-09-05		Drug product	2019-06-24
N211230-001	10512609	2037-09-05	U-2548		2020-01-22
N211230-001	11439597	2037-09-05		Drug product	2022-10-13
N211230-001	11998639	2037-09-05	U-2548	Drug product	2024-06-10
N211230-001	12390419	2037-09-05	U-2548	Drug product	2025-08-26
N211230-001	10912754	2038-06-01	U-3082		2021-03-10
N211230-001	10959976	2038-06-01	U-3151		2021-04-27
N211230-001	11648232	2038-06-01	U-3602		2023-05-26
N211230-001	11865098	2038-06-01	U-2548		2024-02-08
N211230-001	12384743	2038-11-01	U-2548	Drug substance, Drug product	2025-09-03
N211230-001	11560354	2039-03-06	U-3520	Drug product	2023-02-13
N211230-001	10940133	2040-03-19	U-3099		2021-04-07
N211230-001	11160779	2040-03-19	U-3521		2023-02-13
N211230-001	11839598	2040-03-19	U-3765		2023-12-15
N211230-001	11839599	2040-03-19	U-3764		2023-12-15
N211230-001	11850226	2040-03-19	U-3775		2023-12-29
N211230-001	11850227	2040-03-19	U-3775		2023-12-29
N211230-001	11850228	2040-03-19	U-3775		2023-12-29
N211230-001	11857528	2040-03-19	U-3521		2024-01-19
N211230-001	11969404	2040-03-19	U-3892		2024-05-02
N211230-001	11986454	2040-03-19	U-3775		2024-05-31
N211230-001	11986455	2040-03-19	U-3521		2024-05-31
N211230-001	12194016	2040-03-19	U-4106		2025-01-16
N211230-001	12318362	2040-03-19	U-3765		2025-06-10
N211230-001	11771666	2042-12-30	U-3693		2023-10-06
N211230-001	11771667	2042-12-30	U-3693		2023-10-06
N211230-001	11779554	2042-12-30	U-3693		2023-10-12
N211230-001	11793776	2042-12-30	U-3693		2023-10-27
N211230-001	11872203	2042-12-30	U-3693		2024-01-19
N211230-001	11872204	2042-12-30	U-3693		2024-01-19
N211230-001	12005036	2042-12-30	U-3693		2024-06-13
N211230-001	12036194	2042-12-30	U-3693		2024-08-05
N211230-001	12064411	2042-12-30	U-3693		2024-08-26
N211230-001	12090126	2042-12-30	U-3693		2024-09-27
N211230-001	12102609	2042-12-30	U-3693		2024-10-15
N211230-001	12263145	2042-12-30	U-3693		2025-04-11
N211230-002	10351517	2026-06-07	U-2548		2019-08-16
N211230-002	11753368	2026-06-07	U-2548		2023-09-14
N211230-002	12209059	2026-06-07	U-2548		2025-02-07
N211230-002	8877806	2026-06-07	U-2548		2019-06-24
N211230-002	9604917	2026-06-07	U-2548		2019-06-24
N211230-002	8440715	2031-06-11	U-2548		2019-06-24
N211230-002	10195151	2037-09-05		Drug product	2019-06-24
N211230-002	10512609	2037-09-05	U-2548		2020-01-22
N211230-002	11439597	2037-09-05		Drug product	2022-10-13
N211230-002	11998639	2037-09-05	U-2548	Drug product	2024-06-10
N211230-002	12390419	2037-09-05	U-2548	Drug product	2025-08-26
N211230-002	10912754	2038-06-01	U-3082		2021-03-10
N211230-002	10959976	2038-06-01	U-3151		2021-04-27
N211230-002	11648232	2038-06-01	U-3602		2023-05-26
N211230-002	11865098	2038-06-01	U-2548		2024-02-08
N211230-002	12384743	2038-11-01	U-2548	Drug substance, Drug product	2025-09-03
N211230-002	11560354	2039-03-06	U-3520	Drug product	2023-02-13
N211230-002	11160779	2040-03-19	U-3521		2023-02-13
N211230-002	11839598	2040-03-19	U-3765		2023-12-15
N211230-002	11839599	2040-03-19	U-3764		2023-12-15
N211230-002	11850226	2040-03-19	U-3775		2023-12-29
N211230-002	11850227	2040-03-19	U-3775		2023-12-29
N211230-002	11850228	2040-03-19	U-3775		2023-12-29
N211230-002	11857528	2040-03-19	U-3521		2024-01-19
N211230-002	11969404	2040-03-19	U-3892		2024-05-02
N211230-002	11986454	2040-03-19	U-3775		2024-05-31
N211230-002	11986455	2040-03-19	U-3521		2024-05-31
N211230-002	12194016	2040-03-19	U-4106		2025-01-16
N211230-002	11771666	2042-12-30	U-3693		2023-10-06
N211230-002	11771667	2042-12-30	U-3693		2023-10-06
N211230-002	11779554	2042-12-30	U-3693		2023-10-12
N211230-002	11793776	2042-12-30	U-3693		2023-10-27
N211230-002	11872203	2042-12-30	U-3693		2024-01-19
N211230-002	11872204	2042-12-30	U-3693		2024-01-19
N211230-002	12005036	2042-12-30	U-3693		2024-06-13
N211230-002	12036194	2042-12-30	U-3693		2024-08-05
N211230-002	12064411	2042-12-30	U-3693		2024-08-26
N211230-002	12090126	2042-12-30	U-3693		2024-09-27

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N211230-001	ODE-254	2026-06-17
N211230-002	ODE-254	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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N211230-001	SUNOSI	EQ 75MG BASE	TABLET / ORAL	AB	RLD	2019-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211230-002	SUNOSI	EQ 150MG BASE	TABLET / ORAL	AB	RLD, RS	2019-06-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211230-001	SUNOSI	EQ 75MG BASE	TABLET / ORAL		RLD	2019-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211230-002	SUNOSI	EQ 150MG BASE	TABLET / ORAL		RLD, RS	2019-06-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211230-001	SUNOSI	EQ 75MG BASE	TABLET / ORAL		RLD	2019-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211230-002	SUNOSI	EQ 150MG BASE	TABLET / ORAL		RLD, RS	2019-06-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211230-001	SUNOSI	EQ 75MG BASE	TABLET / ORAL		RLD	2019-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211230-002	SUNOSI	EQ 150MG BASE	TABLET / ORAL		RLD, RS	2019-06-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211230-001	SUNOSI	EQ 75MG BASE	TABLET / ORAL		RLD	2019-06-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211230-002	SUNOSI	EQ 150MG BASE	TABLET / ORAL		RLD, RS	2019-06-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211230-001	SUNOSI	EQ 75MG BASE	TABLET / ORAL		RLD	2019-06-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211230-002	SUNOSI	EQ 150MG BASE	TABLET / ORAL		RLD, RS	2019-06-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211230-001	SUNOSI	EQ 75MG BASE	TABLET / ORAL		RLD	2019-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211230-002	SUNOSI	EQ 150MG BASE	TABLET / ORAL		RLD, RS	2019-06-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211230-001	SUNOSI	EQ 75MG BASE	TABLET / ORAL		RLD	2019-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211230-002	SUNOSI	EQ 150MG BASE	TABLET / ORAL		RLD, RS	2019-06-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211230-001	SUNOSI	EQ 75MG BASE	TABLET / ORAL		RLD	2019-06-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211230-002	SUNOSI	EQ 150MG BASE	TABLET / ORAL		RLD, RS	2019-06-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211230-001	SUNOSI	EQ 75MG BASE	TABLET / ORAL		RLD	2019-06-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211230-002	SUNOSI	EQ 150MG BASE	TABLET / ORAL		RLD, RS	2019-06-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211230-001	SUNOSI	EQ 75MG BASE	TABLET / ORAL		RLD	2019-06-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211230-002	SUNOSI	EQ 150MG BASE	TABLET / ORAL		RLD, RS	2019-06-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211230-001	SUNOSI	EQ 75MG BASE	TABLET / ORAL		RLD	2019-06-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211230-002	SUNOSI	EQ 150MG BASE	TABLET / ORAL		RLD, RS	2019-06-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211230-001	SUNOSI	EQ 75MG BASE	TABLET / ORAL		RLD	2019-06-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211230-002	SUNOSI	EQ 150MG BASE	TABLET / ORAL		RLD, RS	2019-06-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211230-001	SUNOSI	EQ 75MG BASE	TABLET / ORAL		RLD	2019-06-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N211230-002	SUNOSI	EQ 150MG BASE	TABLET / ORAL		RLD, RS	2019-06-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N211230-001	SUNOSI	EQ 75MG BASE	TABLET / ORAL		RLD	2019-06-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N211230-002	SUNOSI	EQ 150MG BASE	TABLET / ORAL		RLD, RS	2019-06-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211230-001	SUNOSI	EQ 75MG BASE	TABLET / ORAL		RLD	2019-06-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N211230-002	SUNOSI	EQ 150MG BASE	TABLET / ORAL		RLD, RS	2019-06-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N211230-001	SUNOSI	EQ 75MG BASE	TABLET / ORAL		RLD	2019-06-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N211230-002	SUNOSI	EQ 150MG BASE	TABLET / ORAL		RLD, RS	2019-06-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N211230-001	SUNOSI	EQ 75MG BASE	TABLET / ORAL		RLD	2019-06-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N211230-002	SUNOSI	EQ 150MG BASE	TABLET / ORAL		RLD, RS	2019-06-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N211230-001	SUNOSI	75MG	TABLET / ORAL		RLD	2019-06-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N211230-002	SUNOSI	150MG	TABLET / ORAL		RLD	2019-06-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N211230-001	SUNOSI	EQ 75MG BASE	TABLET / ORAL		RLD	2019-06-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N211230-002	SUNOSI	EQ 150MG BASE	TABLET / ORAL		RLD, RS	2019-06-17	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N211230-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211230-002	AB	1	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N211230-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N211230-002	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 43 · 1,681 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N211230-001	10351517	2026-06-07	U-2548		2019-08-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211230-001	11753368	2026-06-07	U-2548		2023-09-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211230-001	12209059	2026-06-07	U-2548		2025-02-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211230-001	8877806	2026-06-07	U-2548		2019-06-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211230-001	9604917	2026-06-07	U-2548		2019-06-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211230-001	8440715	2031-06-11	U-2548		2019-06-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211230-001	10195151	2037-09-05		Drug product	2019-06-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211230-001	10512609	2037-09-05	U-2548		2020-01-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211230-001	11439597	2037-09-05		Drug product	2022-10-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211230-001	11998639	2037-09-05	U-2548	Drug product	2024-06-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211230-001	12390419	2037-09-05	U-2548	Drug product	2025-08-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211230-001	10912754	2038-06-01	U-3082		2021-03-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211230-001	10959976	2038-06-01	U-3151		2021-04-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211230-001	11648232	2038-06-01	U-3602		2023-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211230-001	11865098	2038-06-01	U-2548		2024-02-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211230-001	12384743	2038-11-01	U-2548	Drug substance, Drug product	2025-09-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211230-001	11560354	2039-03-06	U-3520	Drug product	2023-02-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211230-001	10940133	2040-03-19	U-3099		2021-04-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211230-001	11160779	2040-03-19	U-3521		2023-02-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211230-001	11839598	2040-03-19	U-3765		2023-12-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211230-001	11839599	2040-03-19	U-3764		2023-12-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211230-001	11850226	2040-03-19	U-3775		2023-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211230-001	11850227	2040-03-19	U-3775		2023-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211230-001	11850228	2040-03-19	U-3775		2023-12-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211230-001	11857528	2040-03-19	U-3521		2024-01-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211230-001	11969404	2040-03-19	U-3892		2024-05-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211230-001	11986454	2040-03-19	U-3775		2024-05-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211230-001	11986455	2040-03-19	U-3521		2024-05-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211230-001	12194016	2040-03-19	U-4106		2025-01-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211230-001	12318362	2040-03-19	U-3765		2025-06-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211230-001	11771666	2042-12-30	U-3693		2023-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211230-001	11771667	2042-12-30	U-3693		2023-10-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211230-001	11779554	2042-12-30	U-3693		2023-10-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211230-001	11793776	2042-12-30	U-3693		2023-10-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211230-001	11872203	2042-12-30	U-3693		2024-01-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211230-001	11872204	2042-12-30	U-3693		2024-01-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211230-001	12005036	2042-12-30	U-3693		2024-06-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211230-001	12036194	2042-12-30	U-3693		2024-08-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211230-001	12064411	2042-12-30	U-3693		2024-08-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211230-001	12090126	2042-12-30	U-3693		2024-09-27	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 150 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N211230-001	ODE-254	2026-06-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211230-002	ODE-254	2026-06-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211230-001	ODE-254	2026-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N211230-002	ODE-254	2026-06-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211230-001	ODE-254	2026-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N211230-002	ODE-254	2026-06-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N211230-001	ODE-254	2026-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N211230-002	ODE-254	2026-06-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211230-001	ODE-254	2026-06-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N211230-002	ODE-254	2026-06-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211230-001	ODE-254	2026-06-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N211230-002	ODE-254	2026-06-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211230-001	NCE	2024-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211230-001	ODE-254	2026-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211230-002	NCE	2024-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N211230-002	ODE-254	2026-06-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211230-001	NCE	2024-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211230-001	ODE-254	2026-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211230-002	NCE	2024-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N211230-002	ODE-254	2026-06-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211230-001	NCE	2024-06-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211230-001	ODE-254	2026-06-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211230-002	NCE	2024-06-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N211230-002	ODE-254	2026-06-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211230-001	NCE	2024-06-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211230-001	ODE-254	2026-06-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211230-002	NCE	2024-06-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N211230-002	ODE-254	2026-06-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N211230-001	NCE	2024-06-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211230-001	ODE-254	2026-06-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211230-002	NCE	2024-06-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N211230-002	ODE-254	2026-06-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211230-001	NCE	2024-06-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211230-001	ODE-254	2026-06-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211230-002	NCE	2024-06-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N211230-002	ODE-254	2026-06-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211230-001	NCE	2024-06-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211230-001	ODE-254	2026-06-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211230-002	NCE	2024-06-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N211230-002	ODE-254	2026-06-17	`301d65b070ca…`

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
SUNOSI	SOLRIAMFETOL	Axsome Therapeutics, Inc.	362f206b-73e7-4009-8c34-5a9df55679ab	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211230 application number: NDA211230 ndc (product): 81968-350 ndc (product): 81968-351

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
68727-350	SUNOSI	solriamfetol	Jazz Pharmaceuticals, Inc.	NDA	Current
68727-350	SUNOSI	solriamfetol	Jazz Pharmaceuticals, Inc.	NDA	Current
68727-350	SUNOSI	solriamfetol	Jazz Pharmaceuticals, Inc.	NDA	Current
68727-350	SUNOSI	solriamfetol	Jazz Pharmaceuticals, Inc.	NDA	Current
68727-350	SUNOSI	solriamfetol	Jazz Pharmaceuticals, Inc.	NDA	Current
68727-350	SUNOSI	solriamfetol	Jazz Pharmaceuticals, Inc.	NDA	Current
68727-351	SUNOSI	solriamfetol	Jazz Pharmaceuticals, Inc.	NDA	Current
68727-351	SUNOSI	solriamfetol	Jazz Pharmaceuticals, Inc.	NDA	Current
68727-351	SUNOSI	solriamfetol	Jazz Pharmaceuticals, Inc.	NDA	Current
68727-351	SUNOSI	solriamfetol	Jazz Pharmaceuticals, Inc.	NDA	Current
68727-351	SUNOSI	solriamfetol	Jazz Pharmaceuticals, Inc.	NDA	Current
68727-351	SUNOSI	solriamfetol	Jazz Pharmaceuticals, Inc.	NDA	Current
81968-350	SUNOSI	solriamfetol	Axsome Therapeutics, Inc.	NDA	Current
81968-350	SUNOSI	solriamfetol	Axsome Therapeutics, Inc.	NDA	Current
81968-351	SUNOSI	solriamfetol	Axsome Therapeutics, Inc.	NDA	Current
81968-351	SUNOSI	solriamfetol	Axsome Therapeutics, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74665	SUPPL	2023-06-29
74664	SUPPL	2023-06-29
74653	SUPPL	2023-06-29
72773	SUPPL	2022-12-05
72763	SUPPL	2022-12-02
69136	SUPPL	2021-10-27
69063	SUPPL	2021-10-21
68944	ORIG	2021-10-08
68943	ORIG	2021-10-08
58060	ORIG	2020-03-20
58052	ORIG	2020-03-20
58051	ORIG	2020-03-20
58050	ORIG	2020-03-20
58049	ORIG	2020-03-20
58048	ORIG	2020-03-20
60470	SUPPL	2019-10-09
60273	SUPPL	2019-10-07
58467	ORIG	2019-04-29
58466	ORIG	2019-04-29