Application 204447

Type: NDA
Sponsor: TAKEDA PHARMS USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TRINTELLIX	VORTIOXETINE HYDROBROMIDE	TABLET;ORAL	EQ 5MG BASE	Yes	No
002	TRINTELLIX	VORTIOXETINE HYDROBROMIDE	TABLET;ORAL	EQ 10MG BASE	Yes	No
003	TRINTELLIX	VORTIOXETINE HYDROBROMIDE	TABLET;ORAL	EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	TRINTELLIX	VORTIOXETINE HYDROBROMIDE	TABLET;ORAL	EQ 20MG BASE	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N204447-001	TRINTELLIX	VORTIOXETINE HYDROBROMIDE	EQ 5MG BASE	TABLET / ORAL	RLD	2013-09-30
N204447-002	TRINTELLIX	VORTIOXETINE HYDROBROMIDE	EQ 10MG BASE	TABLET / ORAL	RLD	2013-09-30
N204447-003	TRINTELLIX	VORTIOXETINE HYDROBROMIDE	EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-09-30
N204447-004	TRINTELLIX	VORTIOXETINE HYDROBROMIDE	EQ 20MG BASE	TABLET / ORAL	RLD, RS	2013-09-30

Orange Book patents#

Current patent rows page 1 of 1 · 80 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N204447-001	7144884	2026-06-17	U-1439	Drug substance, Drug product	2013-10-16
N204447-001	7144884*PED	2026-12-17		Pediatric extension
N204447-001	11458134	2027-06-15	U-3463	Drug product	2022-11-02
N204447-001	8969355	2027-06-15	U-1668		2015-03-19
N204447-001	9125908	2027-06-15	U-2309		2018-05-24
N204447-001	9125909	2027-06-15	U-2309		2018-05-24
N204447-001	9125910	2027-06-15	U-2309		2018-05-24
N204447-001	9227946	2027-06-15	U-1668		2016-01-21
N204447-001	9861630	2027-06-15	U-1668		2018-01-18
N204447-001	11458134*PED	2027-12-15		Pediatric extension
N204447-001	8969355*PED	2027-12-15		Pediatric extension
N204447-001	9125908*PED	2027-12-15		Pediatric extension
N204447-001	9125909*PED	2027-12-15		Pediatric extension
N204447-001	9125910*PED	2027-12-15		Pediatric extension
N204447-001	9227946*PED	2027-12-15		Pediatric extension
N204447-001	9861630*PED	2027-12-15		Pediatric extension
N204447-001	8722684	2031-06-30		Drug substance, Drug product	2014-06-09
N204447-001	8722684*PED	2031-12-30		Pediatric extension
N204447-001	9278096	2032-03-21	U-2436		2018-11-13
N204447-001	9278096*PED	2032-09-21		Pediatric extension
N204447-002	7144884	2026-06-17	U-1439	Drug substance, Drug product	2013-10-16
N204447-002	7144884*PED	2026-12-17		Pediatric extension
N204447-002	11458134	2027-06-15	U-3463	Drug product	2022-11-02
N204447-002	8969355	2027-06-15	U-1668		2015-03-19
N204447-002	9125908	2027-06-15	U-2309		2018-05-24
N204447-002	9125909	2027-06-15	U-2309		2018-05-24
N204447-002	9125910	2027-06-15	U-2309		2018-05-24
N204447-002	9227946	2027-06-15	U-1668		2016-01-21
N204447-002	9861630	2027-06-15	U-1668		2018-01-18
N204447-002	11458134*PED	2027-12-15		Pediatric extension
N204447-002	8969355*PED	2027-12-15		Pediatric extension
N204447-002	9125908*PED	2027-12-15		Pediatric extension
N204447-002	9125909*PED	2027-12-15		Pediatric extension
N204447-002	9125910*PED	2027-12-15		Pediatric extension
N204447-002	9227946*PED	2027-12-15		Pediatric extension
N204447-002	9861630*PED	2027-12-15		Pediatric extension
N204447-002	8722684	2031-06-30		Drug substance, Drug product	2014-06-09
N204447-002	8722684*PED	2031-12-30		Pediatric extension
N204447-002	9278096	2032-03-21	U-2436		2018-11-13
N204447-002	9278096*PED	2032-09-21		Pediatric extension
N204447-003	7144884	2026-06-17	U-1439	Drug substance, Drug product	2013-10-16
N204447-003	7144884*PED	2026-12-17		Pediatric extension
N204447-003	11458134	2027-06-15	U-3463	Drug product	2022-11-02
N204447-003	8969355	2027-06-15	U-1668		2015-03-19
N204447-003	9125908	2027-06-15	U-2309		2018-05-24
N204447-003	9125909	2027-06-15	U-2309		2018-05-24
N204447-003	9125910	2027-06-15	U-2309		2018-05-24
N204447-003	9227946	2027-06-15	U-1668		2016-01-21
N204447-003	9861630	2027-06-15	U-1668		2018-01-18
N204447-003	11458134*PED	2027-12-15		Pediatric extension
N204447-003	8969355*PED	2027-12-15		Pediatric extension
N204447-003	9125908*PED	2027-12-15		Pediatric extension
N204447-003	9125909*PED	2027-12-15		Pediatric extension
N204447-003	9125910*PED	2027-12-15		Pediatric extension
N204447-003	9227946*PED	2027-12-15		Pediatric extension
N204447-003	9861630*PED	2027-12-15		Pediatric extension
N204447-003	8722684	2031-06-30		Drug substance, Drug product	2014-06-09
N204447-003	8722684*PED	2031-12-30		Pediatric extension
N204447-003	9278096	2032-03-21	U-2436		2018-11-13
N204447-003	9278096*PED	2032-09-21		Pediatric extension
N204447-004	7144884	2026-06-17	U-1439	Drug substance, Drug product	2013-10-16
N204447-004	7144884*PED	2026-12-17		Pediatric extension
N204447-004	11458134	2027-06-15	U-3463	Drug product	2022-11-02
N204447-004	8969355	2027-06-15	U-1668		2015-03-19
N204447-004	9125908	2027-06-15	U-2309		2018-05-24
N204447-004	9125909	2027-06-15	U-2309		2018-05-24
N204447-004	9125910	2027-06-15	U-2309		2018-05-24
N204447-004	9227946	2027-06-15	U-1668		2016-01-21
N204447-004	9861630	2027-06-15	U-1668		2018-01-18
N204447-004	11458134*PED	2027-12-15		Pediatric extension
N204447-004	8969355*PED	2027-12-15		Pediatric extension
N204447-004	9125908*PED	2027-12-15		Pediatric extension
N204447-004	9125909*PED	2027-12-15		Pediatric extension
N204447-004	9125910*PED	2027-12-15		Pediatric extension
N204447-004	9227946*PED	2027-12-15		Pediatric extension
N204447-004	9861630*PED	2027-12-15		Pediatric extension
N204447-004	8722684	2031-06-30		Drug substance, Drug product	2014-06-09
N204447-004	8722684*PED	2031-12-30		Pediatric extension
N204447-004	9278096	2032-03-21	U-2436		2018-11-13
N204447-004	9278096*PED	2032-09-21		Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 8 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N204447-001	M-232	2026-08-23
N204447-001	PED	2027-02-23
N204447-002	M-232	2026-08-23
N204447-002	PED	2027-02-23
N204447-003	M-232	2026-08-23
N204447-003	PED	2027-02-23
N204447-004	M-232	2026-08-23
N204447-004	PED	2027-02-23

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
2026-08-18 06:07:40	2026-07	N204447-001	TRINTELLIX	EQ 5MG BASE	TABLET / ORAL	RLD	2013-09-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	TRINTELLIX	EQ 10MG BASE	TABLET / ORAL	RLD	2013-09-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-003	TRINTELLIX	EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-09-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-004	TRINTELLIX	EQ 20MG BASE	TABLET / ORAL	RLD, RS	2013-09-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204447-001	TRINTELLIX	EQ 5MG BASE	TABLET / ORAL	RLD	2013-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204447-002	TRINTELLIX	EQ 10MG BASE	TABLET / ORAL	RLD	2013-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204447-003	TRINTELLIX	EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204447-004	TRINTELLIX	EQ 20MG BASE	TABLET / ORAL	RLD, RS	2013-09-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204447-001	TRINTELLIX	EQ 5MG BASE	TABLET / ORAL	RLD	2013-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204447-002	TRINTELLIX	EQ 10MG BASE	TABLET / ORAL	RLD	2013-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204447-003	TRINTELLIX	EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204447-004	TRINTELLIX	EQ 20MG BASE	TABLET / ORAL	RLD, RS	2013-09-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204447-001	TRINTELLIX	EQ 5MG BASE	TABLET / ORAL	RLD	2013-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204447-002	TRINTELLIX	EQ 10MG BASE	TABLET / ORAL	RLD	2013-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204447-003	TRINTELLIX	EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204447-004	TRINTELLIX	EQ 20MG BASE	TABLET / ORAL	RLD, RS	2013-09-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204447-001	TRINTELLIX	EQ 5MG BASE	TABLET / ORAL	RLD	2013-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204447-002	TRINTELLIX	EQ 10MG BASE	TABLET / ORAL	RLD	2013-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204447-003	TRINTELLIX	EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204447-004	TRINTELLIX	EQ 20MG BASE	TABLET / ORAL	RLD, RS	2013-09-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204447-001	TRINTELLIX	EQ 5MG BASE	TABLET / ORAL	RLD	2013-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204447-002	TRINTELLIX	EQ 10MG BASE	TABLET / ORAL	RLD	2013-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204447-003	TRINTELLIX	EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204447-004	TRINTELLIX	EQ 20MG BASE	TABLET / ORAL	RLD, RS	2013-09-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204447-001	TRINTELLIX	EQ 5MG BASE	TABLET / ORAL	RLD	2013-09-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204447-002	TRINTELLIX	EQ 10MG BASE	TABLET / ORAL	RLD	2013-09-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204447-003	TRINTELLIX	EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-09-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204447-004	TRINTELLIX	EQ 20MG BASE	TABLET / ORAL	RLD, RS	2013-09-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204447-001	TRINTELLIX	EQ 5MG BASE	TABLET / ORAL	RLD	2013-09-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204447-002	TRINTELLIX	EQ 10MG BASE	TABLET / ORAL	RLD	2013-09-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204447-003	TRINTELLIX	EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-09-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204447-004	TRINTELLIX	EQ 20MG BASE	TABLET / ORAL	RLD, RS	2013-09-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204447-001	TRINTELLIX	EQ 5MG BASE	TABLET / ORAL	RLD	2013-09-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204447-002	TRINTELLIX	EQ 10MG BASE	TABLET / ORAL	RLD	2013-09-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204447-003	TRINTELLIX	EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-09-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204447-004	TRINTELLIX	EQ 20MG BASE	TABLET / ORAL	RLD, RS	2013-09-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204447-001	TRINTELLIX	EQ 5MG BASE	TABLET / ORAL	RLD	2013-09-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204447-002	TRINTELLIX	EQ 10MG BASE	TABLET / ORAL	RLD	2013-09-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204447-003	TRINTELLIX	EQ 15MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2013-09-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204447-004	TRINTELLIX	EQ 20MG BASE	TABLET / ORAL	RLD, RS	2013-09-30	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-04-04 05:41 UTC	2022-04	N204447-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N204447-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N204447-004	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N204447-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N204447-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N204447-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N204447-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N204447-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N204447-004	AB	1	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 64 · 2,528 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	N204447-001	7144884	2026-06-17	U-1439	Drug substance, Drug product	2013-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-001	7144884*PED	2026-12-17		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-001	11458134	2027-06-15	U-3463	Drug product	2022-11-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-001	8969355	2027-06-15	U-1668		2015-03-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-001	9125908	2027-06-15	U-2309		2018-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-001	9125909	2027-06-15	U-2309		2018-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-001	9125910	2027-06-15	U-2309		2018-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-001	9227946	2027-06-15	U-1668		2016-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-001	9861630	2027-06-15	U-1668		2018-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-001	11458134*PED	2027-12-15		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-001	8969355*PED	2027-12-15		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-001	9125908*PED	2027-12-15		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-001	9125909*PED	2027-12-15		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-001	9125910*PED	2027-12-15		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-001	9227946*PED	2027-12-15		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-001	9861630*PED	2027-12-15		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-001	8722684	2031-06-30		Drug substance, Drug product	2014-06-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-001	8722684*PED	2031-12-30		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-001	9278096	2032-03-21	U-2436		2018-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-001	9278096*PED	2032-09-21		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	7144884	2026-06-17	U-1439	Drug substance, Drug product	2013-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	7144884*PED	2026-12-17		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	11458134	2027-06-15	U-3463	Drug product	2022-11-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	8969355	2027-06-15	U-1668		2015-03-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	9125908	2027-06-15	U-2309		2018-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	9125909	2027-06-15	U-2309		2018-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	9125910	2027-06-15	U-2309		2018-05-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	9227946	2027-06-15	U-1668		2016-01-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	9861630	2027-06-15	U-1668		2018-01-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	11458134*PED	2027-12-15		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	8969355*PED	2027-12-15		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	9125908*PED	2027-12-15		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	9125909*PED	2027-12-15		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	9125910*PED	2027-12-15		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	9227946*PED	2027-12-15		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	9861630*PED	2027-12-15		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	8722684	2031-06-30		Drug substance, Drug product	2014-06-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	8722684*PED	2031-12-30		Pediatric extension		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	9278096	2032-03-21	U-2436		2018-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	9278096*PED	2032-09-21		Pediatric extension		`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 11 · 420 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	N204447-001	M-232	2026-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-001	PED	2027-02-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	M-232	2026-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-002	PED	2027-02-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-003	M-232	2026-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-003	PED	2027-02-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-004	M-232	2026-08-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204447-004	PED	2027-02-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204447-001	M-232	2026-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204447-001	PED	2027-02-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204447-002	M-232	2026-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204447-002	PED	2027-02-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204447-003	M-232	2026-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204447-003	PED	2027-02-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204447-004	M-232	2026-08-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204447-004	PED	2027-02-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204447-001	M-232	2026-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204447-001	PED	2027-02-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204447-002	M-232	2026-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204447-002	PED	2027-02-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204447-003	M-232	2026-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204447-003	PED	2027-02-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204447-004	M-232	2026-08-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204447-004	PED	2027-02-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204447-001	M-232	2026-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204447-001	PED	2027-02-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204447-002	M-232	2026-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204447-002	PED	2027-02-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204447-003	M-232	2026-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204447-003	PED	2027-02-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204447-004	M-232	2026-08-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204447-004	PED	2027-02-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204447-001	M-232	2026-08-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204447-001	PED	2027-02-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204447-002	M-232	2026-08-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204447-002	PED	2027-02-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204447-003	M-232	2026-08-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204447-003	PED	2027-02-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204447-004	M-232	2026-08-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204447-004	PED	2027-02-23	`fd3edfee7708…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Trintellix	VORTIOXETINE	REMEDYREPACK INC.	239215eb-be32-4286-9677-1e5556c6cccf	2026-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204447 application number: NDA204447
Trintellix	VORTIOXETINE	REMEDYREPACK INC.	bd0107e5-1cb9-4b40-a6af-fa65fcbe6b4e	2026-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204447 application number: NDA204447
Trintellix	VORTIOXETINE	Cardinal Health 107, LLC	cb1e9df4-dd74-4073-9d78-bb55593dd000	2026-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204447 application number: NDA204447 ndc (product): 55154-0256 ndc (product): 55154-0257
Trintellix	VORTIOXETINE	Takeda Pharmaceuticals America, Inc.	1a5b68e2-14d0-419d-9ec6-1ca97145e838	2025-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 204447 application number: NDA204447 ndc (product): 64764-720 ndc (product): 64764-750 ndc (product): 64764-730

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 56 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55154-0256	Trintellix	vortioxetine	Cardinal Health	NDA	Current
55154-0256	Trintellix	vortioxetine	Cardinal Health	NDA	Current
55154-0256	Trintellix	vortioxetine	Cardinal Health 107, LLC	NDA	Current
55154-0256	Trintellix	vortioxetine	Cardinal Health 107, LLC	NDA	Current
55154-0256	Trintellix	vortioxetine	Cardinal Health	NDA	Current
55154-0256	Trintellix	vortioxetine	Cardinal Health	NDA	Current
55154-0256	Trintellix	vortioxetine	Cardinal Health	NDA	Current
55154-0256	Trintellix	vortioxetine	Cardinal Health	NDA	Current
55154-0256	Trintellix	vortioxetine	Cardinal Health	NDA	Current
55154-0256	Trintellix	vortioxetine	Cardinal Health	NDA	Current
55154-0256	Trintellix	vortioxetine	Cardinal Health	NDA	Current
55154-0256	Trintellix	vortioxetine	Cardinal Health	NDA	Current
55154-0256	Trintellix	vortioxetine	Cardinal Health	NDA	Current
55154-0256	Trintellix	vortioxetine	Cardinal Health	NDA	Current
55154-0256	Trintellix	vortioxetine	Cardinal Health 107, LLC	NDA	Current
55154-0257	Trintellix	vortioxetine	Cardinal Health	NDA	Current
55154-0257	Trintellix	vortioxetine	Cardinal Health	NDA	Current
55154-0257	Trintellix	vortioxetine	Cardinal Health 107, LLC	NDA	Current
55154-0257	Trintellix	vortioxetine	Cardinal Health 107, LLC	NDA	Current
55154-0257	Trintellix	vortioxetine	Cardinal Health	NDA	Current
55154-0257	Trintellix	vortioxetine	Cardinal Health	NDA	Current
55154-0257	Trintellix	vortioxetine	Cardinal Health	NDA	Current
55154-0257	Trintellix	vortioxetine	Cardinal Health	NDA	Current
55154-0257	Trintellix	vortioxetine	Cardinal Health	NDA	Current
55154-0257	Trintellix	vortioxetine	Cardinal Health	NDA	Current
55154-0257	Trintellix	vortioxetine	Cardinal Health	NDA	Current
55154-0257	Trintellix	vortioxetine	Cardinal Health	NDA	Current
55154-0257	Trintellix	vortioxetine	Cardinal Health	NDA	Current
55154-0257	Trintellix	vortioxetine	Cardinal Health	NDA	Current
55154-0257	Trintellix	vortioxetine	Cardinal Health 107, LLC	NDA	Current
64764-550	Brintellix	vortioxetine	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-560	Brintellix	vortioxetine	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-570	Brintellix	vortioxetine	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-580	Brintellix	vortioxetine	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-720	Trintellix	vortioxetine	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-720	Trintellix	vortioxetine	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-720	Trintellix	vortioxetine	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-720	Trintellix	vortioxetine	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-720	Trintellix	vortioxetine	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-720	Trintellix	vortioxetine	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-730	Trintellix	vortioxetine	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-730	Trintellix	vortioxetine	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-730	Trintellix	vortioxetine	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-730	Trintellix	vortioxetine	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-730	Trintellix	vortioxetine	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-730	Trintellix	vortioxetine	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-750	Trintellix	vortioxetine	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-750	Trintellix	vortioxetine	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-750	Trintellix	vortioxetine	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-750	Trintellix	vortioxetine	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-750	Trintellix	vortioxetine	Takeda Pharmaceuticals America, Inc.	NDA	Current
64764-750	Trintellix	vortioxetine	Takeda Pharmaceuticals America, Inc.	NDA	Current
70518-2642	Trintellix	vortioxetine	REMEDYREPACK INC.	NDA	Current
70518-2642	Trintellix	vortioxetine	REMEDYREPACK INC.	NDA	Current
70518-2642	Trintellix	vortioxetine	REMEDYREPACK INC.	NDA	Current
70518-2642	Trintellix	vortioxetine	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
75282	SUPPL	2023-08-24
75281	SUPPL	2023-08-24
75276	SUPPL	2023-08-24
75233	SUPPL	2023-08-22
75198	SUPPL	2023-08-22
70730	SUPPL	2022-04-07
70729	SUPPL	2022-04-07
70728	SUPPL	2022-04-07
68823	SUPPL	2021-09-30
68822	SUPPL	2021-09-30
68735	SUPPL	2021-09-23
66015	SUPPL	2021-01-28
66010	SUPPL	2021-01-28
66009	SUPPL	2021-01-28
65989	SUPPL	2021-01-26
65988	SUPPL	2021-01-26
65233	SUPPL	2020-11-16
65224	SUPPL	2020-11-16
59450	SUPPL	2019-07-25
59449	SUPPL	2019-07-25
59437	SUPPL	2019-07-24
56082	SUPPL	2018-10-23
56048	SUPPL	2018-10-22
54014	SUPPL	2018-05-04
54002	SUPPL	2018-05-03
48034	SUPPL	2017-04-14
47988	SUPPL	2017-04-12
47872	SUPPL	2017-04-05
47850	SUPPL	2017-04-04
47556	SUPPL	2017-03-14
47533	SUPPL	2017-03-13
47278	SUPPL	2017-02-22
45560	SUPPL	2016-10-19
45219	SUPPL	2016-08-30
45183	SUPPL	2016-08-30
10345	SUPPL	2016-05-04
40393	SUPPL	2016-05-03
40392	SUPPL	2014-09-09
19564	SUPPL	2014-07-29
10344	SUPPL	2014-07-21
44902	ORIG	2013-10-30
43465	ORIG	2013-10-30
32563	ORIG	2013-10-02
19563	ORIG	2013-10-01