Application 022567

Type: NDA
Sponsor: ALLERGAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VIIBRYD	VILAZODONE HYDROCHLORIDE	TABLET;ORAL	10MG	Yes	Yes
002	VIIBRYD	VILAZODONE HYDROCHLORIDE	TABLET;ORAL	20MG	Yes	No
003	VIIBRYD	VILAZODONE HYDROCHLORIDE	TABLET;ORAL	40MG	Yes	No

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	TE codes	RLD / RS	Approval date
N022567-001	VIIBRYD	VILAZODONE HYDROCHLORIDE	10MG	TABLET / ORAL	AB	RLD, RS	2011-01-21
N022567-002	VIIBRYD	VILAZODONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RLD	2011-01-21
N022567-003	VIIBRYD	VILAZODONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	RLD	2011-01-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N022567-001	AB
N022567-002	AB
N022567-003	AB

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 4 · 129 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
2026-09-14 22:38:34	2026-08	N022567-001	VIIBRYD	10MG	TABLET / ORAL	AB	RLD, RS	2011-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022567-002	VIIBRYD	20MG	TABLET / ORAL	AB	RLD	2011-01-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022567-003	VIIBRYD	40MG	TABLET / ORAL	AB	RLD	2011-01-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022567-001	VIIBRYD	10MG	TABLET / ORAL	AB	RLD, RS	2011-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022567-002	VIIBRYD	20MG	TABLET / ORAL	AB	RLD	2011-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022567-003	VIIBRYD	40MG	TABLET / ORAL	AB	RLD	2011-01-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022567-001	VIIBRYD	10MG	TABLET / ORAL	AB	RLD, RS	2011-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022567-002	VIIBRYD	20MG	TABLET / ORAL	AB	RLD	2011-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022567-003	VIIBRYD	40MG	TABLET / ORAL	AB	RLD	2011-01-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022567-001	VIIBRYD	10MG	TABLET / ORAL	AB	RLD, RS	2011-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022567-002	VIIBRYD	20MG	TABLET / ORAL	AB	RLD	2011-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022567-003	VIIBRYD	40MG	TABLET / ORAL	AB	RLD	2011-01-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022567-001	VIIBRYD	10MG	TABLET / ORAL	AB	RLD, RS	2011-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022567-002	VIIBRYD	20MG	TABLET / ORAL	AB	RLD	2011-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022567-003	VIIBRYD	40MG	TABLET / ORAL	AB	RLD	2011-01-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022567-001	VIIBRYD	10MG	TABLET / ORAL	AB	RLD, RS	2011-01-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022567-002	VIIBRYD	20MG	TABLET / ORAL	AB	RLD	2011-01-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022567-003	VIIBRYD	40MG	TABLET / ORAL	AB	RLD	2011-01-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022567-001	VIIBRYD	10MG	TABLET / ORAL	AB	RLD, RS	2011-01-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022567-002	VIIBRYD	20MG	TABLET / ORAL	AB	RLD	2011-01-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022567-003	VIIBRYD	40MG	TABLET / ORAL	AB	RLD	2011-01-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022567-001	VIIBRYD	10MG	TABLET / ORAL	AB	RLD, RS	2011-01-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022567-002	VIIBRYD	20MG	TABLET / ORAL	AB	RLD	2011-01-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022567-003	VIIBRYD	40MG	TABLET / ORAL	AB	RLD	2011-01-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022567-001	VIIBRYD	10MG	TABLET / ORAL	AB	RLD, RS	2011-01-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022567-002	VIIBRYD	20MG	TABLET / ORAL	AB	RLD	2011-01-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022567-003	VIIBRYD	40MG	TABLET / ORAL	AB	RLD	2011-01-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022567-001	VIIBRYD	10MG	TABLET / ORAL	AB	RLD, RS	2011-01-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022567-002	VIIBRYD	20MG	TABLET / ORAL	AB	RLD	2011-01-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022567-003	VIIBRYD	40MG	TABLET / ORAL	AB	RLD	2011-01-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022567-001	VIIBRYD	10MG	TABLET / ORAL	AB	RLD, RS	2011-01-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022567-002	VIIBRYD	20MG	TABLET / ORAL	AB	RLD	2011-01-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022567-003	VIIBRYD	40MG	TABLET / ORAL	AB	RLD	2011-01-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022567-001	VIIBRYD	10MG	TABLET / ORAL	AB	RLD, RS	2011-01-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022567-002	VIIBRYD	20MG	TABLET / ORAL	AB	RLD	2011-01-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022567-003	VIIBRYD	40MG	TABLET / ORAL	AB	RLD	2011-01-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022567-001	VIIBRYD	10MG	TABLET / ORAL	AB	RLD, RS	2011-01-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022567-002	VIIBRYD	20MG	TABLET / ORAL	AB	RLD	2011-01-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022567-003	VIIBRYD	40MG	TABLET / ORAL	AB	RLD	2011-01-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022567-001	VIIBRYD	10MG	TABLET / ORAL	AB	RLD, RS	2011-01-21	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N022567-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022567-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N022567-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022567-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022567-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022567-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022567-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022567-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022567-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022567-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022567-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022567-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022567-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022567-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022567-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022567-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022567-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022567-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022567-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022567-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022567-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022567-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022567-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022567-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022567-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022567-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022567-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022567-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022567-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022567-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022567-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022567-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022567-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022567-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022567-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022567-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022567-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022567-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022567-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022567-001	AB	1	`301d65b070ca…`

Observed Orange Book patent history#

Patent history page 1 of 10 · 396 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022567-001	7834020	2022-06-05	U-839	Drug substance, Drug product	2011-01-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022567-001	8193195	2022-06-05	U-839		2012-06-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022567-001	8236804	2022-06-05	U-839		2012-08-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022567-001	8673921	2022-06-05		Drug substance, Drug product	2014-03-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022567-001	7834020*PED	2022-12-05		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022567-001	8193195*PED	2022-12-05		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022567-001	8236804*PED	2022-12-05		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022567-001	8673921*PED	2022-12-05		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022567-002	7834020	2022-06-05	U-839	Drug substance, Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022567-002	8193195	2022-06-05	U-839		2012-06-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022567-002	8236804	2022-06-05	U-839			`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022567-002	8673921	2022-06-05		Drug substance, Drug product	2014-03-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022567-002	7834020*PED	2022-12-05		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022567-002	8193195*PED	2022-12-05		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022567-002	8236804*PED	2022-12-05		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022567-002	8673921*PED	2022-12-05		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022567-003	7834020	2022-06-05	U-839	Drug substance, Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022567-003	8193195	2022-06-05	U-839		2012-06-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022567-003	8236804	2022-06-05	U-839			`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022567-003	8673921	2022-06-05		Drug substance, Drug product	2014-03-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022567-003	7834020*PED	2022-12-05		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022567-003	8193195*PED	2022-12-05		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022567-003	8236804*PED	2022-12-05		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022567-003	8673921*PED	2022-12-05		Pediatric extension		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022567-001	7834020	2022-06-05	U-839	Drug substance, Drug product	2011-01-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022567-001	8193195	2022-06-05	U-839		2012-06-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022567-001	8236804	2022-06-05	U-839		2012-08-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022567-001	8673921	2022-06-05		Drug substance, Drug product	2014-03-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022567-001	7834020*PED	2022-12-05		Pediatric extension		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022567-001	8193195*PED	2022-12-05		Pediatric extension		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022567-001	8236804*PED	2022-12-05		Pediatric extension		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022567-001	8673921*PED	2022-12-05		Pediatric extension		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022567-002	7834020	2022-06-05	U-839	Drug substance, Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022567-002	8193195	2022-06-05	U-839		2012-06-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022567-002	8236804	2022-06-05	U-839			`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022567-002	8673921	2022-06-05		Drug substance, Drug product	2014-03-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022567-002	7834020*PED	2022-12-05		Pediatric extension		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022567-002	8193195*PED	2022-12-05		Pediatric extension		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022567-002	8236804*PED	2022-12-05		Pediatric extension		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022567-002	8673921*PED	2022-12-05		Pediatric extension		`5d02ea3f76ae…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 120 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	N022567-001	M-254	2023-01-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022567-001	PED	2023-07-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022567-002	M-254	2023-01-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022567-002	PED	2023-07-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022567-003	M-254	2023-01-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022567-003	PED	2023-07-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022567-001	M-254	2023-01-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022567-001	PED	2023-07-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022567-002	M-254	2023-01-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022567-002	PED	2023-07-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022567-003	M-254	2023-01-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022567-003	PED	2023-07-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022567-001	M-254	2023-01-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022567-001	PED	2023-07-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022567-002	M-254	2023-01-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022567-002	PED	2023-07-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022567-003	M-254	2023-01-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022567-003	PED	2023-07-31	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N022567-001	M-254	2023-01-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022567-001	PED	2023-07-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022567-002	M-254	2023-01-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022567-002	PED	2023-07-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022567-003	M-254	2023-01-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022567-003	PED	2023-07-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022567-001	M-254	2023-01-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022567-001	PED	2023-07-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022567-002	M-254	2023-01-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022567-002	PED	2023-07-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022567-003	M-254	2023-01-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022567-003	PED	2023-07-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022567-001	M-254	2023-01-31	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022567-001	PED	2023-07-31	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022567-002	M-254	2023-01-31	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022567-002	PED	2023-07-31	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022567-003	M-254	2023-01-31	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022567-003	PED	2023-07-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022567-001	M-254	2023-01-31	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022567-001	PED	2023-07-31	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022567-002	M-254	2023-01-31	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022567-002	PED	2023-07-31	`5aa47cf7b7d7…`

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
VIIBRYD	VILAZODONE HYDROCHLORIDE	Allergan, Inc.	4c55ccfb-c4cf-11df-851a-0800200c9a66	2023-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022567 application number: NDA022567 ndc (product): 0456-1101 ndc (product): 0456-1140 ndc (product): 0456-1110 ndc (product): 0456-1120 ndc (product): 0456-1100

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 · 44 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0456-1100	VIIBRYD	vilazodone hydrochloride	Allergan, Inc.	NDA	Current
0456-1100	VIIBRYD	vilazodone hydrochloride	Allergan, Inc.	NDA	Current
0456-1100	VIIBRYD	vilazodone hydrochloride	Allergan, Inc.	NDA	Current
0456-1100	VIIBRYD	vilazodone hydrochloride	Allergan, Inc.	NDA	Current
0456-1100	VIIBRYD	vilazodone hydrochloride	Allergan, Inc.	NDA	Current
0456-1100	VIIBRYD	vilazodone hydrochloride	Allergan, Inc.	NDA	Current
0456-1101	VIIBRYD	vilazodone hydrochloride	Allergan, Inc.	NDA	Current
0456-1101	VIIBRYD	vilazodone hydrochloride	Allergan, Inc.	NDA	Current
0456-1101	VIIBRYD	vilazodone hydrochloride	Allergan, Inc.	NDA	Current
0456-1101	VIIBRYD	vilazodone hydrochloride	Allergan, Inc.	NDA	Current
0456-1101	VIIBRYD	vilazodone hydrochloride	Allergan, Inc.	NDA	Current
0456-1101	VIIBRYD	vilazodone hydrochloride	Allergan, Inc.	NDA	Current
0456-1110	VIIBRYD	vilazodone hydrochloride	Allergan, Inc.	NDA	Current
0456-1110	VIIBRYD	vilazodone hydrochloride	Allergan, Inc.	NDA	Current
0456-1110	VIIBRYD	vilazodone hydrochloride	Allergan, Inc.	NDA	Current
0456-1110	VIIBRYD	vilazodone hydrochloride	Allergan, Inc.	NDA	Current
0456-1110	VIIBRYD	vilazodone hydrochloride	Allergan, Inc.	NDA	Current
0456-1110	VIIBRYD	vilazodone hydrochloride	Allergan, Inc.	NDA	Current
0456-1120	VIIBRYD	vilazodone hydrochloride	Allergan, Inc.	NDA	Current
0456-1120	VIIBRYD	vilazodone hydrochloride	Allergan, Inc.	NDA	Current
0456-1120	VIIBRYD	vilazodone hydrochloride	Allergan, Inc.	NDA	Current
0456-1120	VIIBRYD	vilazodone hydrochloride	Allergan, Inc.	NDA	Current
0456-1120	VIIBRYD	vilazodone hydrochloride	Allergan, Inc.	NDA	Current
0456-1120	VIIBRYD	vilazodone hydrochloride	Allergan, Inc.	NDA	Current
0456-1140	VIIBRYD	vilazodone hydrochloride	Allergan, Inc.	NDA	Current
0456-1140	VIIBRYD	vilazodone hydrochloride	Allergan, Inc.	NDA	Current
0456-1140	VIIBRYD	vilazodone hydrochloride	Allergan, Inc.	NDA	Current
0456-1140	VIIBRYD	vilazodone hydrochloride	Allergan, Inc.	NDA	Current
0456-1140	VIIBRYD	vilazodone hydrochloride	Allergan, Inc.	NDA	Current
0456-1140	VIIBRYD	vilazodone hydrochloride	Allergan, Inc.	NDA	Current
51407-691	vilazodone	vilazodone hydrochloride	Golden State Medical Supply, Inc.	NDA AUTHORIZED GENERIC	Current
51407-692	Vilazodone	vilazodone hydrochloride	Golden State Medical Supply, Inc.	NDA AUTHORIZED GENERIC	Current
51407-693	Vilazodone	vilazodone hydrochloride	Golden State Medical Supply, Inc.	NDA AUTHORIZED GENERIC	Current
55154-4624	VIIBRYD	vilazodone hydrochloride	Cardinal Health 107, LLC	NDA	Current
55154-4624	VIIBRYD	vilazodone hydrochloride	Cardinal Health	NDA	Current
55154-4624	VIIBRYD	vilazodone hydrochloride	Cardinal Health	NDA	Current
55154-4624	VIIBRYD	vilazodone hydrochloride	Cardinal Health	NDA	Current
55154-4627	VIIBRYD	vilazodone hydrochloride	Cardinal Health 107, LLC	NDA	Current
55154-4627	VIIBRYD	vilazodone hydrochloride	Cardinal Health	NDA	Current
55154-4627	VIIBRYD	vilazodone hydrochloride	Cardinal Health	NDA	Current
55154-4627	VIIBRYD	vilazodone hydrochloride	Cardinal Health	NDA	Current
60505-4772	vilazodone	vilazodone hydrochloride	Apotex Corp	NDA AUTHORIZED GENERIC	Current
60505-4773	Vilazodone	vilazodone hydrochloride	Apotex Corp	NDA AUTHORIZED GENERIC	Current
60505-4774	Vilazodone	vilazodone hydrochloride	Apotex Corp	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78265	SUPPL	2024-04-25
78229	SUPPL	2024-04-24
78200	SUPPL	2024-04-22
75243	SUPPL	2023-08-22
75177	SUPPL	2023-08-21
68772	SUPPL	2021-09-24
68771	SUPPL	2021-09-24
68724	SUPPL	2021-09-22
61763	SUPPL	2020-02-04
61756	SUPPL	2020-02-03
61755	SUPPL	2020-02-03
46786	SUPPL	2017-01-11
46785	SUPPL	2017-01-11
46680	SUPPL	2017-01-06
45275	SUPPL	2016-09-08
45244	SUPPL	2016-09-06
7539	SUPPL	2015-04-02
17717	SUPPL	2015-03-19
17718	SUPPL	2014-07-17
7540	SUPPL	2014-07-17
29865	SUPPL	2014-04-09
17716	SUPPL	2014-04-08
17715	SUPPL	2013-12-19
7538	SUPPL	2013-12-19
17714	SUPPL	2013-01-11
29864	SUPPL	2012-12-26
23713	ORIG	2012-02-13
17713	SUPPL	2011-09-23
7536	SUPPL	2011-09-23
7537	SUPPL	2011-07-06
24342	ORIG	2011-03-01
22059	ORIG	2011-03-01
7535	ORIG	2011-01-26
38842	ORIG	2011-01-24
64950	ORIG	1900-01-01
63981	ORIG	1900-01-01
63980	ORIG	1900-01-01