Application 204370

Type: NDA
Sponsor: ALLERGAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VRAYLAR	CARIPRAZINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 1.5MG BASE	Yes	No
002	VRAYLAR	CARIPRAZINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 3MG BASE	Yes	No
003	VRAYLAR	CARIPRAZINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 4.5MG BASE	Yes	No
004	VRAYLAR	CARIPRAZINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 6MG BASE	Yes	Yes
005	VRAYLAR	CARIPRAZINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 0.5MG BASE	Yes	No
006	VRAYLAR	CARIPRAZINE HYDROCHLORIDE	CAPSULE;ORAL	EQ 0.75MG BASE	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N204370-001	VRAYLAR	CARIPRAZINE HYDROCHLORIDE	EQ 1.5MG BASE	CAPSULE / ORAL	RLD, RS	2015-09-17
N204370-002	VRAYLAR	CARIPRAZINE HYDROCHLORIDE	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-09-17
N204370-003	VRAYLAR	CARIPRAZINE HYDROCHLORIDE	EQ 4.5MG BASE	CAPSULE / ORAL	RLD	2015-09-17
N204370-004	VRAYLAR	CARIPRAZINE HYDROCHLORIDE	EQ 6MG BASE	CAPSULE / ORAL	RLD	2015-09-17
N204370-005	VRAYLAR	CARIPRAZINE HYDROCHLORIDE	EQ 0.5MG BASE	CAPSULE / ORAL	RLD	2025-12-18
N204370-006	VRAYLAR	CARIPRAZINE HYDROCHLORIDE	EQ 0.75MG BASE	CAPSULE / ORAL	RLD	2025-12-18

Orange Book patents#

Current patent rows page 1 of 2 · 106 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N204370-001	7943621	2028-12-16		Drug substance, Drug product	2015-10-16
N204370-001	7943621*PED	2029-06-16		Pediatric extension
N204370-001	RE47350	2029-07-16	U-1750		2019-05-15
N204370-001	RE47350	2029-07-16	U-2543		2019-05-15
N204370-001	RE47350	2029-07-16	U-2544		2019-05-15
N204370-001	RE47350	2029-07-16	U-2545		2019-05-15
N204370-001	RE47350	2029-07-16	U-3503		2019-05-15
N204370-001	RE49110	2029-07-16	U-2543		2022-07-21
N204370-001	RE49110	2029-07-16	U-2544		2022-07-21
N204370-001	RE49110	2029-07-16	U-2545		2022-07-21
N204370-001	RE49110	2029-07-16	U-3503		2022-07-21
N204370-001	RE49302	2029-07-16	U-2543		2023-01-13
N204370-001	RE49302	2029-07-16	U-2544		2023-01-13
N204370-001	RE49302	2029-07-16	U-2545		2023-01-13
N204370-001	RE49302	2029-07-16	U-3503		2023-01-13
N204370-001	7737142	2029-09-17	U-1750	Drug substance, Drug product	2015-10-16
N204370-001	7737142	2029-09-17	U-2543	Drug substance, Drug product	2015-10-16
N204370-001	7737142	2029-09-17	U-2544	Drug substance, Drug product	2015-10-16
N204370-001	7737142	2029-09-17	U-2545	Drug substance, Drug product	2015-10-16
N204370-001	7737142	2029-09-17	U-3503	Drug substance, Drug product	2015-10-16
N204370-001	RE47350*PED	2030-01-16		Pediatric extension
N204370-001	RE49110*PED	2030-01-16		Pediatric extension
N204370-001	RE49302*PED	2030-01-16		Pediatric extension
N204370-001	7737142*PED	2030-03-17		Pediatric extension
N204370-002	7943621	2028-12-16		Drug substance, Drug product	2015-10-16
N204370-002	7943621*PED	2029-06-16		Pediatric extension
N204370-002	RE49110	2029-07-16	U-2543		2022-07-21
N204370-002	RE49110	2029-07-16	U-2544		2022-07-21
N204370-002	RE49110	2029-07-16	U-2545		2022-07-21
N204370-002	RE49110	2029-07-16	U-3503		2022-07-21
N204370-002	RE49302	2029-07-16	U-2543		2023-01-13
N204370-002	RE49302	2029-07-16	U-2544		2023-01-13
N204370-002	RE49302	2029-07-16	U-2545		2023-01-13
N204370-002	RE49302	2029-07-16	U-3503		2023-01-13
N204370-002	7737142	2029-09-17	U-1750	Drug substance, Drug product	2015-10-16
N204370-002	7737142	2029-09-17	U-2543	Drug substance, Drug product	2015-10-16
N204370-002	7737142	2029-09-17	U-2544	Drug substance, Drug product	2015-10-16
N204370-002	7737142	2029-09-17	U-2545	Drug substance, Drug product	2015-10-16
N204370-002	7737142	2029-09-17	U-3503	Drug substance, Drug product	2015-10-16
N204370-002	RE49110*PED	2030-01-16		Pediatric extension
N204370-002	RE49302*PED	2030-01-16		Pediatric extension
N204370-002	7737142*PED	2030-03-17		Pediatric extension
N204370-003	7943621	2028-12-16		Drug substance, Drug product	2015-10-16
N204370-003	7943621*PED	2029-06-16		Pediatric extension
N204370-003	RE49110	2029-07-16	U-2543		2022-07-21
N204370-003	RE49110	2029-07-16	U-2544		2022-07-21
N204370-003	RE49110	2029-07-16	U-2545		2022-07-21
N204370-003	RE49302	2029-07-16	U-2543		2023-01-13
N204370-003	RE49302	2029-07-16	U-2544		2023-01-13
N204370-003	RE49302	2029-07-16	U-2545		2023-01-13
N204370-003	RE49302	2029-07-16	U-3503		2023-01-13
N204370-003	7737142	2029-09-17	U-1750	Drug substance, Drug product	2015-10-16
N204370-003	7737142	2029-09-17	U-2543	Drug substance, Drug product	2015-10-16
N204370-003	7737142	2029-09-17	U-2544	Drug substance, Drug product	2015-10-16
N204370-003	RE49110*PED	2030-01-16		Pediatric extension
N204370-003	RE49302*PED	2030-01-16		Pediatric extension
N204370-003	7737142*PED	2030-03-17		Pediatric extension
N204370-004	7943621	2028-12-16		Drug substance, Drug product	2015-10-16
N204370-004	7943621*PED	2029-06-16		Pediatric extension
N204370-004	RE49110	2029-07-16	U-2543		2022-07-21
N204370-004	RE49110	2029-07-16	U-2544		2022-07-21
N204370-004	RE49110	2029-07-16	U-2545		2022-07-21
N204370-004	RE49302	2029-07-16	U-2543		2023-01-13
N204370-004	RE49302	2029-07-16	U-2544		2023-01-13
N204370-004	RE49302	2029-07-16	U-2545		2023-01-13
N204370-004	RE49302	2029-07-16	U-3503		2023-01-13
N204370-004	7737142	2029-09-17	U-1750	Drug substance, Drug product	2015-10-16
N204370-004	7737142	2029-09-17	U-2543	Drug substance, Drug product	2015-10-16
N204370-004	7737142	2029-09-17	U-2544	Drug substance, Drug product	2015-10-16
N204370-004	RE49110*PED	2030-01-16		Pediatric extension
N204370-004	RE49302*PED	2030-01-16		Pediatric extension
N204370-004	7737142*PED	2030-03-17		Pediatric extension
N204370-005	7943621	2028-12-20		Drug substance, Drug product	2026-01-14
N204370-005	7943621*PED	2029-06-20		Pediatric extension
N204370-005	RE47350	2029-07-16	U-2543		2026-01-14
N204370-005	RE47350	2029-07-16	U-2544		2026-01-14
N204370-005	RE47350	2029-07-16	U-2545		2026-01-14
N204370-005	RE47350	2029-07-16	U-3503		2026-01-14
N204370-005	RE49110	2029-07-16	U-2543		2026-01-14
N204370-005	RE49110	2029-07-16	U-2544		2026-01-14

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 22 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N204370-001	M-14	2028-12-18
N204370-001	NPP	2028-12-18
N204370-001	PED	2029-06-18
N204370-001	PED	2029-06-18
N204370-002	M-14	2028-12-18
N204370-002	NPP	2028-12-18
N204370-002	PED	2029-06-18
N204370-002	PED	2029-06-18
N204370-003	M-14	2028-12-18
N204370-003	NPP	2028-12-18
N204370-003	PED	2029-06-18
N204370-003	PED	2029-06-18
N204370-004	M-14	2028-12-18
N204370-004	PED	2029-06-18
N204370-005	M-14	2028-12-18
N204370-005	NPP	2028-12-18
N204370-005	PED	2029-06-18
N204370-005	PED	2029-06-18
N204370-006	M-14	2028-12-18
N204370-006	NPP	2028-12-18
N204370-006	PED	2029-06-18
N204370-006	PED	2029-06-18

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 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N204370-001	VRAYLAR	EQ 1.5MG BASE	CAPSULE / ORAL	RLD, RS	2015-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-002	VRAYLAR	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-003	VRAYLAR	EQ 4.5MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-004	VRAYLAR	EQ 6MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-005	VRAYLAR	EQ 0.5MG BASE	CAPSULE / ORAL	RLD	2025-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-006	VRAYLAR	EQ 0.75MG BASE	CAPSULE / ORAL	RLD	2025-12-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204370-001	VRAYLAR	EQ 1.5MG BASE	CAPSULE / ORAL	RLD, RS	2015-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204370-002	VRAYLAR	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204370-003	VRAYLAR	EQ 4.5MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204370-004	VRAYLAR	EQ 6MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204370-001	VRAYLAR	EQ 1.5MG BASE	CAPSULE / ORAL	RLD, RS	2015-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204370-002	VRAYLAR	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204370-003	VRAYLAR	EQ 4.5MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204370-004	VRAYLAR	EQ 6MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204370-001	VRAYLAR	EQ 1.5MG BASE	CAPSULE / ORAL	RLD, RS	2015-09-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204370-002	VRAYLAR	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204370-003	VRAYLAR	EQ 4.5MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204370-004	VRAYLAR	EQ 6MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204370-001	VRAYLAR	EQ 1.5MG BASE	CAPSULE / ORAL	RLD, RS	2015-09-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204370-002	VRAYLAR	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204370-003	VRAYLAR	EQ 4.5MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204370-004	VRAYLAR	EQ 6MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204370-001	VRAYLAR	EQ 1.5MG BASE	CAPSULE / ORAL	RLD, RS	2015-09-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204370-002	VRAYLAR	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204370-003	VRAYLAR	EQ 4.5MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204370-004	VRAYLAR	EQ 6MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204370-001	VRAYLAR	EQ 1.5MG BASE	CAPSULE / ORAL	RLD, RS	2015-09-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204370-002	VRAYLAR	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204370-003	VRAYLAR	EQ 4.5MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204370-004	VRAYLAR	EQ 6MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204370-001	VRAYLAR	EQ 1.5MG BASE	CAPSULE / ORAL	RLD, RS	2015-09-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204370-002	VRAYLAR	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204370-003	VRAYLAR	EQ 4.5MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204370-004	VRAYLAR	EQ 6MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204370-001	VRAYLAR	EQ 1.5MG BASE	CAPSULE / ORAL	RLD, RS	2015-09-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204370-002	VRAYLAR	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204370-003	VRAYLAR	EQ 4.5MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204370-004	VRAYLAR	EQ 6MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204370-001	VRAYLAR	EQ 1.5MG BASE	CAPSULE / ORAL	RLD, RS	2015-09-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204370-002	VRAYLAR	EQ 3MG BASE	CAPSULE / ORAL	RLD	2015-09-17	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204370-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204370-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204370-003	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N204370-004	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N204370-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N204370-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N204370-003	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N204370-004	AB	1	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 45 · 1,786 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N204370-001	7943621	2028-12-16		Drug substance, Drug product	2015-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-001	RE47350	2029-07-16	U-1750		2019-05-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-001	RE47350	2029-07-16	U-2543		2019-05-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-001	RE47350	2029-07-16	U-3503		2019-05-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-001	RE47350	2029-07-16	U-2544		2019-05-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-001	RE47350	2029-07-16	U-2545		2019-05-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-001	RE49110	2029-07-16	U-2545		2022-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-001	RE49110	2029-07-16	U-2544		2022-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-001	RE49110	2029-07-16	U-2543		2022-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-001	RE49110	2029-07-16	U-3503		2022-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-001	RE49302	2029-07-16	U-2543		2023-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-001	RE49302	2029-07-16	U-3503		2023-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-001	RE49302	2029-07-16	U-2544		2023-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-001	RE49302	2029-07-16	U-2545		2023-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-001	7737142	2029-09-17	U-2544	Drug substance, Drug product	2015-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-001	7737142	2029-09-17	U-2545	Drug substance, Drug product	2015-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-001	7737142	2029-09-17	U-2543	Drug substance, Drug product	2015-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-001	7737142	2029-09-17	U-1750	Drug substance, Drug product	2015-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-001	7737142	2029-09-17	U-3503	Drug substance, Drug product	2015-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-002	7943621	2028-12-16		Drug substance, Drug product	2015-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-002	RE49110	2029-07-16	U-2545		2022-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-002	RE49110	2029-07-16	U-2543		2022-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-002	RE49110	2029-07-16	U-2544		2022-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-002	RE49110	2029-07-16	U-3503		2022-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-002	RE49302	2029-07-16	U-2543		2023-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-002	RE49302	2029-07-16	U-2545		2023-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-002	RE49302	2029-07-16	U-2544		2023-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-002	RE49302	2029-07-16	U-3503		2023-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-002	7737142	2029-09-17	U-2545	Drug substance, Drug product	2015-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-002	7737142	2029-09-17	U-2544	Drug substance, Drug product	2015-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-002	7737142	2029-09-17	U-1750	Drug substance, Drug product	2015-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-002	7737142	2029-09-17	U-3503	Drug substance, Drug product	2015-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-002	7737142	2029-09-17	U-2543	Drug substance, Drug product	2015-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-003	7943621	2028-12-16		Drug substance, Drug product	2015-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-003	RE49110	2029-07-16	U-2544		2022-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-003	RE49110	2029-07-16	U-2543		2022-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-003	RE49110	2029-07-16	U-2545		2022-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-003	RE49302	2029-07-16	U-2543		2023-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-003	RE49302	2029-07-16	U-2544		2023-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204370-003	RE49302	2029-07-16	U-3503		2023-01-13	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 6 · 226 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204370-001	I-904	2025-12-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204370-002	I-904	2025-12-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204370-003	I-904	2025-12-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204370-004	I-904	2025-12-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204370-001	I-904	2025-12-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204370-002	I-904	2025-12-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204370-003	I-904	2025-12-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204370-004	I-904	2025-12-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204370-001	I-904	2025-12-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204370-002	I-904	2025-12-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204370-003	I-904	2025-12-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204370-004	I-904	2025-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204370-001	I-904	2025-12-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204370-002	I-904	2025-12-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204370-003	I-904	2025-12-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204370-004	I-904	2025-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204370-001	I-904	2025-12-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204370-002	I-904	2025-12-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204370-003	I-904	2025-12-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204370-004	I-904	2025-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204370-001	I-904	2025-12-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204370-002	I-904	2025-12-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204370-003	I-904	2025-12-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204370-004	I-904	2025-12-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204370-001	I-904	2025-12-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204370-002	I-904	2025-12-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204370-003	I-904	2025-12-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204370-004	I-904	2025-12-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204370-001	I-904	2025-12-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204370-002	I-904	2025-12-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204370-003	I-904	2025-12-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204370-004	I-904	2025-12-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204370-001	I-904	2025-12-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204370-002	I-904	2025-12-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204370-003	I-904	2025-12-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204370-004	I-904	2025-12-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204370-001	I-904	2025-12-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204370-002	I-904	2025-12-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204370-003	I-904	2025-12-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204370-004	I-904	2025-12-16	`79d66fd596c7…`

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
Vraylar	CARIPRAZINE	Allergan, Inc.	4b5f7c65-aa2d-452a-b3db-bc85c06ff12f	2025-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204370 application number: NDA204370 ndc (product): 61874-160 ndc (product): 61874-130 ndc (product): 61874-170 ndc (product): 61874-115 ndc (product): 61874-145

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
61874-115	Vraylar	cariprazine	Allergan, Inc.	NDA	Current
61874-115	Vraylar	cariprazine	Allergan, Inc.	NDA	Current
61874-115	Vraylar	cariprazine	Allergan, Inc.	NDA	Current
61874-115	Vraylar	cariprazine	Allergan, Inc.	NDA	Current
61874-115	Vraylar	cariprazine	Allergan, Inc.	NDA	Current
61874-115	Vraylar	cariprazine	Allergan, Inc.	NDA	Current
61874-130	Vraylar	cariprazine	Allergan, Inc.	NDA	Current
61874-130	Vraylar	cariprazine	Allergan, Inc.	NDA	Current
61874-130	Vraylar	cariprazine	Allergan, Inc.	NDA	Current
61874-130	Vraylar	cariprazine	Allergan, Inc.	NDA	Current
61874-130	Vraylar	cariprazine	Allergan, Inc.	NDA	Current
61874-130	Vraylar	cariprazine	Allergan, Inc.	NDA	Current
61874-145	Vraylar	cariprazine	Allergan, Inc.	NDA	Current
61874-145	Vraylar	cariprazine	Allergan, Inc.	NDA	Current
61874-145	Vraylar	cariprazine	Allergan, Inc.	NDA	Current
61874-145	Vraylar	cariprazine	Allergan, Inc.	NDA	Current
61874-145	Vraylar	cariprazine	Allergan, Inc.	NDA	Current
61874-145	Vraylar	cariprazine	Allergan, Inc.	NDA	Current
61874-160	Vraylar	cariprazine	Allergan, Inc.	NDA	Current
61874-160	Vraylar	cariprazine	Allergan, Inc.	NDA	Current
61874-160	Vraylar	cariprazine	Allergan, Inc.	NDA	Current
61874-160	Vraylar	cariprazine	Allergan, Inc.	NDA	Current
61874-160	Vraylar	cariprazine	Allergan, Inc.	NDA	Current
61874-160	Vraylar	cariprazine	Allergan, Inc.	NDA	Current
61874-170	Vraylar	cariprazine	Allergan, Inc.	NDA	Current
61874-170	Vraylar	cariprazine	Allergan, Inc.	NDA	Current
61874-170	Vraylar	cariprazine	Allergan, Inc.	NDA	Current
61874-170	Vraylar	cariprazine	Allergan, Inc.	NDA	Current
61874-170	Vraylar	cariprazine	Allergan, Inc.	NDA	Current
61874-170	Vraylar	cariprazine	Allergan, Inc.	NDA	Current
70518-3157	Vraylar	cariprazine	REMEDYREPACK INC.	NDA	Current
70518-3157	Vraylar	cariprazine	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85143	SUPPL	2026-02-24
85141	SUPPL	2026-02-24
84490	SUPPL	2025-12-22
84489	SUPPL	2025-12-22
84488	SUPPL	2025-12-22
84487	SUPPL	2025-12-22
84479	SUPPL	2025-12-19
84478	SUPPL	2025-12-19
84477	SUPPL	2025-12-19
84476	SUPPL	2025-12-19
80422	SUPPL	2024-11-26
80344	SUPPL	2024-11-25
80342	SUPPL	2024-11-25
72928	SUPPL	2022-12-20
72924	SUPPL	2022-12-19
72923	SUPPL	2022-12-19
58946	SUPPL	2019-06-04
58878	SUPPL	2019-05-29
58877	SUPPL	2019-05-24
56809	SUPPL	2018-12-19
50431	SUPPL	2017-11-15
50430	SUPPL	2017-11-15
50405	SUPPL	2017-11-14
50404	SUPPL	2017-11-14
47397	SUPPL	2017-03-02
47308	SUPPL	2017-02-24
22954	ORIG	2015-10-28
40380	ORIG	2015-09-18
10333	ORIG	2015-09-18