Application 215430

Type: NDA
Sponsor: AXSOME THERAPEUTICS, INC.

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AUVELITY	DEXTROMETHORPHAN HYDROBROMIDE AND BUPROPION HYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	45MG/105MG	No	No
002	AUVELITY	BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE	TABLET, EXTENDED RELEASE;ORAL	105MG;30MG	Yes	No

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

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
N215430-001	AUVELITY	BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE	105MG;45MG	TABLET, EXTENDED RELEASE / ORAL		RLD, RS	2022-08-18
N215430-002	AUVELITY	BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE	105MG;30MG	TABLET, EXTENDED RELEASE / ORAL		RLD	2026-04-30

Orange Book patents#

Current patent rows page 1 of 4 · 268 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215430-001	8569328	2032-07-18	U-3419	Drug product	2022-09-16
N215430-001	8569328	2032-07-18	U-4516	Drug product	2022-09-16
N215430-001	10058518	2034-11-05	U-3419		2022-09-16
N215430-001	10058518	2034-11-05	U-4522		2022-09-16
N215430-001	10064857	2034-11-05	U-3419		2022-09-16
N215430-001	10064857	2034-11-05	U-4517		2022-09-16
N215430-001	10080727	2034-11-05	U-3419		2022-09-16
N215430-001	10080727	2034-11-05	U-4520		2022-09-16
N215430-001	10092560	2034-11-05	U-3419		2022-09-16
N215430-001	10092560	2034-11-05	U-4517		2022-09-16
N215430-001	10092561	2034-11-05	U-3419		2022-09-16
N215430-001	10092561	2034-11-05	U-4517		2022-09-16
N215430-001	10105327	2034-11-05	U-3419		2022-09-16
N215430-001	10105361	2034-11-05	U-3419		2022-09-16
N215430-001	10105361	2034-11-05	U-4522		2022-09-16
N215430-001	10251879	2034-11-05	U-3419		2022-09-16
N215430-001	10251879	2034-11-05	U-4517		2022-09-16
N215430-001	10463634	2034-11-05	U-3419		2022-09-16
N215430-001	10463634	2034-11-05	U-4517		2022-09-16
N215430-001	10512643	2034-11-05	U-3419		2022-09-16
N215430-001	10512643	2034-11-05	U-4517		2022-09-16
N215430-001	10548857	2034-11-05	U-3419		2022-09-16
N215430-001	10596167	2034-11-05	U-3419		2022-09-16
N215430-001	10596167	2034-11-05	U-4517		2022-09-16
N215430-001	10772850	2034-11-05	U-3419		2022-09-16
N215430-001	10780066	2034-11-05	U-3419		2022-09-16
N215430-001	10780066	2034-11-05	U-4517		2022-09-16
N215430-001	10786469	2034-11-05	U-3419		2022-09-16
N215430-001	10786496	2034-11-05	U-3419		2022-09-16
N215430-001	10786496	2034-11-05	U-4517		2022-09-16
N215430-001	10799497	2034-11-05	U-3419		2022-09-16
N215430-001	10806710	2034-11-05	U-3419		2022-09-16
N215430-001	10806710	2034-11-05	U-4517		2022-09-16
N215430-001	10864209	2034-11-05	U-3419		2022-09-16
N215430-001	10874663	2034-11-05	U-3419		2022-09-16
N215430-001	10874664	2034-11-05	U-3419		2022-09-16
N215430-001	10874665	2034-11-05	U-3419		2022-09-16
N215430-001	10881624	2034-11-05	U-3419		2022-09-16
N215430-001	10881624	2034-11-05	U-4517		2022-09-16
N215430-001	10881657	2034-11-05	U-3419		2022-09-16
N215430-001	10894046	2034-11-05	U-3419		2022-09-16
N215430-001	10894047	2034-11-05	U-3419		2022-09-16
N215430-001	10898453	2034-11-05	U-3419		2022-09-16
N215430-001	10933034	2034-11-05	U-3419		2022-09-16
N215430-001	10945973	2034-11-05	U-3419		2022-09-16
N215430-001	10966941	2034-11-05	U-3419		2022-09-16
N215430-001	10966941	2034-11-05	U-4517		2022-09-16
N215430-001	10966974	2034-11-05	U-3419		2022-09-16
N215430-001	11007189	2034-11-05	U-4516		2026-05-29
N215430-001	11020389	2034-11-05	U-3419		2022-09-16
N215430-001	11058648	2034-11-05	U-3419		2022-09-16
N215430-001	11065248	2034-11-05	U-3419		2025-11-20
N215430-001	11065248	2034-11-05	U-4517		2025-11-20
N215430-001	11090300	2034-11-05	U-3419		2022-09-16
N215430-001	11096937	2034-11-05	U-3419		2022-09-16
N215430-001	11123343	2034-11-05	U-3419		2022-09-16
N215430-001	11123344	2034-11-05	U-3419		2025-11-20
N215430-001	11123344	2034-11-05	U-4517		2025-11-20
N215430-001	11129826	2034-11-05	U-3419		2022-09-16
N215430-001	11141388	2034-11-05	U-3419		2022-09-16
N215430-001	11141416	2034-11-05	U-3419		2022-09-16
N215430-001	11147808	2034-11-05	U-3419		2022-09-16
N215430-001	11185515	2034-11-05	U-3419		2022-09-16
N215430-001	11191739	2034-11-05	U-3419	Drug product	2022-09-16
N215430-001	11191739	2034-11-05	U-4516	Drug product	2022-09-16
N215430-001	11197839	2034-11-05	U-3419	Drug product	2022-09-16
N215430-001	11197839	2034-11-05	U-4516	Drug product	2022-09-16
N215430-001	11207281	2034-11-05	U-3419		2022-09-16
N215430-001	11207281	2034-11-05	U-4537		2022-09-16
N215430-001	11213521	2034-11-05	U-3419		2022-09-16
N215430-001	11229640	2034-11-05	U-3419		2022-09-16
N215430-001	11234946	2034-11-05	U-3419		2022-09-16
N215430-001	11234946	2034-11-05	U-4526		2022-09-16
N215430-001	11253491	2034-11-05	U-3419		2022-09-16
N215430-001	11253492	2034-11-05	U-3419		2022-09-16
N215430-001	11253492	2034-11-05	U-4526		2022-09-16
N215430-001	11273133	2034-11-05	U-3419		2022-09-16
N215430-001	11273133	2034-11-05	U-4526		2022-09-16
N215430-001	11273134	2034-11-05	U-3419		2022-09-16
N215430-001	11273134	2034-11-05	U-4517		2022-09-16

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215430-001	I-913	2029-04-30
N215430-002	I-913	2029-04-30

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.

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	N215430-001	AUVELITY	105MG;45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-08-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215430-002	AUVELITY	105MG;30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2026-04-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215430-001	AUVELITY	105MG;45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-08-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215430-002	AUVELITY	105MG;30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2026-04-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215430-001	AUVELITY	105MG;45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-08-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215430-001	AUVELITY	105MG;45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215430-001	AUVELITY	105MG;45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215430-001	AUVELITY	105MG;45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-08-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215430-001	AUVELITY	105MG;45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-08-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215430-001	AUVELITY	105MG;45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215430-001	AUVELITY	105MG;45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215430-001	AUVELITY	105MG;45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215430-001	AUVELITY	105MG;45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-08-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215430-001	AUVELITY	105MG;45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-08-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215430-001	AUVELITY	105MG;45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-08-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215430-001	AUVELITY	105MG;45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-08-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215430-001	AUVELITY	105MG;45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-08-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215430-001	AUVELITY	105MG;45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-08-18	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215430-001	AUVELITY	105MG;45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-08-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215430-001	AUVELITY	105MG;45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-08-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215430-001	AUVELITY	105MG;45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-08-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215430-001	AUVELITY	105MG;45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-08-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215430-001	AUVELITY	105MG;45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-08-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215430-001	AUVELITY	105MG;45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-08-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215430-001	AUVELITY	105MG;45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-08-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215430-001	AUVELITY	105MG;45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-08-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215430-001	AUVELITY	105MG;45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-08-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215430-001	AUVELITY	105MG;45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-08-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N215430-001	AUVELITY	105MG;45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-08-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N215430-001	AUVELITY	105MG;45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-08-18	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215430-001	AUVELITY	105MG;45MG	TABLET, EXTENDED RELEASE / ORAL	RLD, RS	2022-08-18	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215430-002	AUVELITY	105MG;30MG	TABLET, EXTENDED RELEASE / ORAL	RLD	2026-04-30	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 92 · 3,655 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	N215430-001	8569328	2032-07-18	U-3419	Drug product	2022-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215430-001	8569328	2032-07-18	U-4516	Drug product	2022-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215430-001	10058518	2034-11-05	U-3419		2022-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215430-001	10058518	2034-11-05	U-4522		2022-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215430-001	10064857	2034-11-05	U-3419		2022-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215430-001	10064857	2034-11-05	U-4517		2022-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215430-001	10080727	2034-11-05	U-3419		2022-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215430-001	10080727	2034-11-05	U-4520		2022-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215430-001	10092560	2034-11-05	U-3419		2022-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215430-001	10092560	2034-11-05	U-4517		2022-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215430-001	10092561	2034-11-05	U-3419		2022-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215430-001	10092561	2034-11-05	U-4517		2022-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215430-001	10105327	2034-11-05	U-3419		2022-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215430-001	10105361	2034-11-05	U-3419		2022-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215430-001	10105361	2034-11-05	U-4522		2022-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215430-001	10251879	2034-11-05	U-3419		2022-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215430-001	10251879	2034-11-05	U-4517		2022-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215430-001	10463634	2034-11-05	U-3419		2022-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215430-001	10463634	2034-11-05	U-4517		2022-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215430-001	10512643	2034-11-05	U-3419		2022-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215430-001	10512643	2034-11-05	U-4517		2022-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215430-001	10548857	2034-11-05	U-3419		2022-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215430-001	10596167	2034-11-05	U-3419		2022-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215430-001	10596167	2034-11-05	U-4517		2022-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215430-001	10772850	2034-11-05	U-3419		2022-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215430-001	10780066	2034-11-05	U-3419		2022-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215430-001	10780066	2034-11-05	U-4517		2022-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215430-001	10786469	2034-11-05	U-3419		2022-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215430-001	10786496	2034-11-05	U-3419		2022-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215430-001	10786496	2034-11-05	U-4517		2022-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215430-001	10799497	2034-11-05	U-3419		2022-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215430-001	10806710	2034-11-05	U-3419		2022-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215430-001	10806710	2034-11-05	U-4517		2022-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215430-001	10864209	2034-11-05	U-3419		2022-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215430-001	10874663	2034-11-05	U-3419		2022-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215430-001	10874664	2034-11-05	U-3419		2022-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215430-001	10874665	2034-11-05	U-3419		2022-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215430-001	10881624	2034-11-05	U-3419		2022-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215430-001	10881624	2034-11-05	U-4517		2022-09-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215430-001	10881657	2034-11-05	U-3419		2022-09-16	`84e616aacf4f…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N215430-001	I-913	2029-04-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N215430-002	I-913	2029-04-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N215430-001	I-913	2029-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215430-002	I-913	2029-04-30	`caaa826d4ba7…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215430-001	NP	2025-08-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215430-001	NP	2025-08-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215430-001	NP	2025-08-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215430-001	NP	2025-08-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215430-001	NP	2025-08-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215430-001	NP	2025-08-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215430-001	NP	2025-08-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215430-001	NP	2025-08-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215430-001	NP	2025-08-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215430-001	NP	2025-08-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215430-001	NP	2025-08-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215430-001	NP	2025-08-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N215430-001	NP	2025-08-18	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N215430-001	NP	2025-08-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N215430-001	NP	2025-08-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N215430-001	NP	2025-08-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N215430-001	NP	2025-08-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N215430-001	NP	2025-08-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N215430-001	NP	2025-08-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N215430-001	NP	2025-08-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N215430-001	NP	2025-08-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N215430-001	NP	2025-08-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N215430-001	NP	2025-08-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N215430-001	NP	2025-08-18	`f41ea6bd6efb…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215430-001	I-913	2029-04-30	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N215430-002	I-913	2029-04-30	`a50c72e98297…`

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
AUVELITY	DEXTROMETHORPHAN HYDROBROMIDE, BUPROPION HYDROCHLORIDE	Axsome Therapeutics, Inc.	dcefda7c-9a68-278e-e053-2995a90aec79	2026-08-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 215430 application number: NDA215430 ndc (product): 81968-045

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
81968-045	AUVELITY	dextromethorphan hydrobromide, bupropion hydrochloride	Axsome Therapeutics, Inc.	NDA	Current
81968-045	AUVELITY	dextromethorphan hydrobromide, bupropion hydrochloride	Axsome Therapeutics, Inc.	NDA	Current
81968-045	AUVELITY	dextromethorphan hydrobromide, bupropion hydrochloride	Axsome Therapeutics, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85807	SUPPL	2026-05-12
85805	SUPPL	2026-05-12
85818	SUPPL	2026-05-06
85819	SUPPL	2026-05-04
85806	SUPPL	2026-05-01
84097	SUPPL	2025-11-06
84096	SUPPL	2025-11-06
84092	SUPPL	2025-11-06
78921	ORIG	2024-06-27
78431	SUPPL	2024-05-08
78420	SUPPL	2024-05-07
71853	ORIG	2022-08-19
71851	ORIG	2022-08-19
71849	ORIG	2022-08-19