Application 200603

Type: NDA
Sponsor: SUNOVION PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LATUDA	LURASIDONE HYDROCHLORIDE	TABLET;ORAL	40MG	Yes	Yes
002	LATUDA	LURASIDONE HYDROCHLORIDE	TABLET;ORAL	80MG	Yes	No
003	LATUDA	LURASIDONE HYDROCHLORIDE	TABLET;ORAL	20MG	Yes	No
004	LATUDA	LURASIDONE HYDROCHLORIDE	TABLET;ORAL	120MG	Yes	No
005	LATUDA	LURASIDONE HYDROCHLORIDE	TABLET;ORAL	60MG	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N200603-001	LATUDA	LURASIDONE HYDROCHLORIDE	40MG	TABLET / ORAL	AB	RLD, RS	2010-10-28
N200603-002	LATUDA	LURASIDONE HYDROCHLORIDE	80MG	TABLET / ORAL	AB	RLD	2010-10-28
N200603-003	LATUDA	LURASIDONE HYDROCHLORIDE	20MG	TABLET / ORAL	AB	RLD	2011-12-07
N200603-004	LATUDA	LURASIDONE HYDROCHLORIDE	120MG	TABLET / ORAL	AB	RLD	2012-04-26
N200603-005	LATUDA	LURASIDONE HYDROCHLORIDE	60MG	TABLET / ORAL	AB	RLD	2013-07-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
N200603-001	AB
N200603-002	AB
N200603-003	AB
N200603-004	AB
N200603-005	AB

Orange Book patents#

Current patent rows page 1 of 1 · 55 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N200603-001	8729085	2026-05-26		Drug product	2014-05-29
N200603-001	8883794	2026-05-26		Drug product	2014-11-12
N200603-001	9555027	2026-05-26	U-543	Drug product	2017-03-01
N200603-001	9907794	2026-05-26		Drug product	2018-03-19
N200603-001	8729085*PED	2026-11-26		Pediatric extension
N200603-001	8883794*PED	2026-11-26		Pediatric extension
N200603-001	9907794*PED	2026-11-26		Pediatric extension
N200603-001	9259423	2031-05-23	U-1822		2016-03-15
N200603-001	9827242	2031-05-23	U-2199		2017-12-19
N200603-001	9827242	2031-05-23	U-2201		2017-12-19
N200603-001	9259423*PED	2031-11-23		Pediatric extension
N200603-002	8729085	2026-05-26		Drug product	2014-05-29
N200603-002	8883794	2026-05-26		Drug product	2014-11-12
N200603-002	9555027	2026-05-26	U-543	Drug product	2017-03-01
N200603-002	9907794	2026-05-26		Drug product	2018-03-19
N200603-002	8729085*PED	2026-11-26		Pediatric extension
N200603-002	8883794*PED	2026-11-26		Pediatric extension
N200603-002	9907794*PED	2026-11-26		Pediatric extension
N200603-002	9259423	2031-05-23	U-1822		2016-03-15
N200603-002	9827242	2031-05-23	U-2199		2017-12-19
N200603-002	9827242	2031-05-23	U-2201		2017-12-19
N200603-002	9259423*PED	2031-11-23		Pediatric extension
N200603-003	8729085	2026-05-26		Drug product	2014-05-29
N200603-003	8883794	2026-05-26		Drug product	2014-11-12
N200603-003	9555027	2026-05-26	U-543	Drug product	2017-03-01
N200603-003	9907794	2026-05-26		Drug product	2018-03-19
N200603-003	8729085*PED	2026-11-26		Pediatric extension
N200603-003	8883794*PED	2026-11-26		Pediatric extension
N200603-003	9907794*PED	2026-11-26		Pediatric extension
N200603-003	9259423	2031-05-23	U-1822		2016-03-15
N200603-003	9827242	2031-05-23	U-2199		2017-12-19
N200603-003	9827242	2031-05-23	U-2201		2017-12-19
N200603-003	9259423*PED	2031-11-23		Pediatric extension
N200603-004	8729085	2026-05-26		Drug product	2014-05-29
N200603-004	8883794	2026-05-26		Drug product	2014-11-12
N200603-004	9555027	2026-05-26	U-543	Drug product	2017-03-01
N200603-004	9907794	2026-05-26		Drug product	2018-03-19
N200603-004	8729085*PED	2026-11-26		Pediatric extension
N200603-004	8883794*PED	2026-11-26		Pediatric extension
N200603-004	9907794*PED	2026-11-26		Pediatric extension
N200603-004	9259423	2031-05-23	U-1822		2016-03-15
N200603-004	9827242	2031-05-23	U-2199		2017-12-19
N200603-004	9827242	2031-05-23	U-2201		2017-12-19
N200603-004	9259423*PED	2031-11-23		Pediatric extension
N200603-005	8729085	2026-05-26		Drug product	2014-05-29
N200603-005	8883794	2026-05-26		Drug product	2014-11-12
N200603-005	9555027	2026-05-26	U-543	Drug product	2017-03-01
N200603-005	9907794	2026-05-26		Drug product	2018-03-19
N200603-005	8729085*PED	2026-11-26		Pediatric extension
N200603-005	8883794*PED	2026-11-26		Pediatric extension
N200603-005	9907794*PED	2026-11-26		Pediatric extension
N200603-005	9259423	2031-05-23	U-1822		2016-03-15
N200603-005	9827242	2031-05-23	U-2199		2017-12-19
N200603-005	9827242	2031-05-23	U-2201		2017-12-19
N200603-005	9259423*PED	2031-11-23		Pediatric extension

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 6 · 205 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
2026-02-19 14:30 UTC	2026-02	N200603-001	LATUDA	40MG	TABLET / ORAL	AB	RLD, RS	2010-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-002	LATUDA	80MG	TABLET / ORAL	AB	RLD	2010-10-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-003	LATUDA	20MG	TABLET / ORAL	AB	RLD	2011-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-004	LATUDA	120MG	TABLET / ORAL	AB	RLD	2012-04-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-005	LATUDA	60MG	TABLET / ORAL	AB	RLD	2013-07-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200603-001	LATUDA	40MG	TABLET / ORAL	AB	RLD, RS	2010-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200603-002	LATUDA	80MG	TABLET / ORAL	AB	RLD	2010-10-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200603-003	LATUDA	20MG	TABLET / ORAL	AB	RLD	2011-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200603-004	LATUDA	120MG	TABLET / ORAL	AB	RLD	2012-04-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200603-005	LATUDA	60MG	TABLET / ORAL	AB	RLD	2013-07-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200603-001	LATUDA	40MG	TABLET / ORAL	AB	RLD, RS	2010-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200603-002	LATUDA	80MG	TABLET / ORAL	AB	RLD	2010-10-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200603-003	LATUDA	20MG	TABLET / ORAL	AB	RLD	2011-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200603-004	LATUDA	120MG	TABLET / ORAL	AB	RLD	2012-04-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200603-005	LATUDA	60MG	TABLET / ORAL	AB	RLD	2013-07-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200603-001	LATUDA	40MG	TABLET / ORAL	AB	RLD, RS	2010-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200603-002	LATUDA	80MG	TABLET / ORAL	AB	RLD	2010-10-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200603-003	LATUDA	20MG	TABLET / ORAL	AB	RLD	2011-12-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200603-004	LATUDA	120MG	TABLET / ORAL	AB	RLD	2012-04-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200603-005	LATUDA	60MG	TABLET / ORAL	AB	RLD	2013-07-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200603-001	LATUDA	40MG	TABLET / ORAL	AB	RLD, RS	2010-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200603-002	LATUDA	80MG	TABLET / ORAL	AB	RLD	2010-10-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200603-003	LATUDA	20MG	TABLET / ORAL	AB	RLD	2011-12-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200603-004	LATUDA	120MG	TABLET / ORAL	AB	RLD	2012-04-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200603-005	LATUDA	60MG	TABLET / ORAL	AB	RLD	2013-07-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200603-001	LATUDA	40MG	TABLET / ORAL	AB	RLD, RS	2010-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200603-002	LATUDA	80MG	TABLET / ORAL	AB	RLD	2010-10-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200603-003	LATUDA	20MG	TABLET / ORAL	AB	RLD	2011-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200603-004	LATUDA	120MG	TABLET / ORAL	AB	RLD	2012-04-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200603-005	LATUDA	60MG	TABLET / ORAL	AB	RLD	2013-07-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200603-001	LATUDA	40MG	TABLET / ORAL	AB	RLD, RS	2010-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200603-002	LATUDA	80MG	TABLET / ORAL	AB	RLD	2010-10-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200603-003	LATUDA	20MG	TABLET / ORAL	AB	RLD	2011-12-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200603-004	LATUDA	120MG	TABLET / ORAL	AB	RLD	2012-04-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200603-005	LATUDA	60MG	TABLET / ORAL	AB	RLD	2013-07-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200603-001	LATUDA	40MG	TABLET / ORAL	AB	RLD, RS	2010-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200603-002	LATUDA	80MG	TABLET / ORAL	AB	RLD	2010-10-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200603-003	LATUDA	20MG	TABLET / ORAL	AB	RLD	2011-12-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200603-004	LATUDA	120MG	TABLET / ORAL	AB	RLD	2012-04-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200603-005	LATUDA	60MG	TABLET / ORAL	AB	RLD	2013-07-12	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N200603-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200603-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200603-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200603-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200603-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200603-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200603-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200603-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200603-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200603-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N200603-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200603-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200603-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200603-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200603-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200603-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200603-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200603-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200603-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200603-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200603-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200603-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200603-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200603-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200603-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200603-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200603-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200603-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200603-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200603-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200603-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200603-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200603-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200603-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200603-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200603-005	AB	1	`5bbf6a4d5a75…`

Observed Orange Book patent history#

Patent history page 1 of 82 · 3,275 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	N200603-001	8729085	2026-05-26		Drug product	2014-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-001	8883794	2026-05-26		Drug product	2014-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-001	9555027	2026-05-26	U-543	Drug product	2017-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-001	9907794	2026-05-26		Drug product	2018-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-001	8729085*PED	2026-11-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-001	8883794*PED	2026-11-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-001	9907794*PED	2026-11-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-001	9259423	2031-05-23	U-1822		2016-03-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-001	9827242	2031-05-23	U-2199		2017-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-001	9827242	2031-05-23	U-2201		2017-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-001	9259423*PED	2031-11-23		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-002	8729085	2026-05-26		Drug product	2014-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-002	8883794	2026-05-26		Drug product	2014-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-002	9555027	2026-05-26	U-543	Drug product	2017-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-002	9907794	2026-05-26		Drug product	2018-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-002	8729085*PED	2026-11-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-002	8883794*PED	2026-11-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-002	9907794*PED	2026-11-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-002	9259423	2031-05-23	U-1822		2016-03-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-002	9827242	2031-05-23	U-2201		2017-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-002	9827242	2031-05-23	U-2199		2017-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-002	9259423*PED	2031-11-23		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-003	8729085	2026-05-26		Drug product	2014-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-003	8883794	2026-05-26		Drug product	2014-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-003	9555027	2026-05-26	U-543	Drug product	2017-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-003	9907794	2026-05-26		Drug product	2018-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-003	8729085*PED	2026-11-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-003	8883794*PED	2026-11-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-003	9907794*PED	2026-11-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-003	9259423	2031-05-23	U-1822		2016-03-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-003	9827242	2031-05-23	U-2199		2017-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-003	9827242	2031-05-23	U-2201		2017-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-003	9259423*PED	2031-11-23		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-004	8729085	2026-05-26		Drug product	2014-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-004	8883794	2026-05-26		Drug product	2014-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-004	9555027	2026-05-26	U-543	Drug product	2017-03-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-004	9907794	2026-05-26		Drug product	2018-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-004	8729085*PED	2026-11-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-004	8883794*PED	2026-11-26		Pediatric extension		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N200603-004	9907794*PED	2026-11-26		Pediatric extension		`011fe1cb6892…`

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
2019-12-13 00:20 UTC	2019-12	N200603-001	M-195	2020-01-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200603-001	NPP	2020-01-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200603-001	PED	2020-07-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200603-001	PED	2020-07-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200603-001	NPP	2021-03-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200603-002	NPP	2020-01-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200603-002	PED	2020-07-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200603-002	NPP	2021-03-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200603-003	M-195	2020-01-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200603-003	NPP	2020-01-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200603-003	PED	2020-07-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200603-003	PED	2020-07-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200603-003	NPP	2021-03-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200603-005	M-195	2020-01-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200603-005	NPP	2020-01-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200603-005	PED	2020-07-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200603-005	PED	2020-07-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N200603-005	NPP	2021-03-05	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N200603-001	NPP	2021-03-05	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N200603-002	NPP	2021-03-05	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N200603-003	NPP	2021-03-05	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N200603-005	NPP	2021-03-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N200603-001	NPP	2021-03-05	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N200603-002	NPP	2021-03-05	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N200603-003	NPP	2021-03-05	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N200603-005	NPP	2021-03-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N200603-001	NPP	2021-03-05	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N200603-002	NPP	2021-03-05	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N200603-003	NPP	2021-03-05	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N200603-005	NPP	2021-03-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N200603-001	M-195	2020-01-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N200603-001	NPP	2020-01-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N200603-001	PED	2020-07-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N200603-001	PED	2020-07-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N200603-001	NPP	2021-03-05	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N200603-002	NPP	2020-01-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N200603-002	PED	2020-07-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N200603-002	NPP	2021-03-05	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N200603-003	M-195	2020-01-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N200603-003	NPP	2020-01-27	`8869cabd3fbd…`

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
Latuda	LURASIDONE HYDROCHLORIDE	Sumitomo Pharma America, Inc.	afad3051-9df2-4c54-9684-e8262a133af8	2025-01-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 200603 application number: NDA200603 ndc (product): 63402-306 ndc (product): 63402-302 ndc (product): 63402-304 ndc (product): 63402-312 ndc (product): 63402-308

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63402-302	Latuda	lurasidone hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-302	Latuda	lurasidone hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-302	Latuda	lurasidone hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-302	Latuda	lurasidone hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-304	Latuda	lurasidone hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-304	Latuda	lurasidone hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-304	Latuda	lurasidone hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-304	Latuda	lurasidone hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-306	Latuda	lurasidone hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-306	Latuda	lurasidone hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-306	Latuda	lurasidone hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-306	Latuda	lurasidone hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-308	Latuda	lurasidone hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-308	Latuda	lurasidone hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-308	Latuda	lurasidone hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-308	Latuda	lurasidone hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-312	Latuda	lurasidone hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-312	Latuda	lurasidone hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-312	Latuda	lurasidone hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-312	Latuda	lurasidone hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
70518-1812	Latuda	lurasidone hydrochloride	REMEDYREPACK INC.	NDA	Current
70518-1812	Latuda	lurasidone hydrochloride	REMEDYREPACK INC.	NDA	Current
70518-1824	Latuda	lurasidone hydrochloride	REMEDYREPACK INC.	NDA	Current
70518-1936	Latuda	lurasidone hydrochloride	REMEDYREPACK INC.	NDA	Current
70518-1936	Latuda	lurasidone hydrochloride	REMEDYREPACK INC.	NDA	Current
70518-3010	Latuda	lurasidone hydrochloride	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81082	SUPPL	2025-02-06
80936	SUPPL	2025-02-05
80935	SUPPL	2025-02-05
61179	SUPPL	2019-12-06
61178	SUPPL	2019-12-06
61162	SUPPL	2019-12-05
53010	SUPPL	2018-03-15
52854	SUPPL	2018-03-08
51322	SUPPL	2018-01-22
51321	SUPPL	2018-01-22
49863	SUPPL	2017-09-26
49858	SUPPL	2017-09-26
47384	SUPPL	2017-03-02
47355	SUPPL	2017-02-27
47074	SUPPL	2017-02-01
47072	SUPPL	2017-02-01
47044	SUPPL	2017-01-31
47043	SUPPL	2017-01-31
46877	SUPPL	2017-01-18
46802	SUPPL	2017-01-11
52324	SUPPL	2016-12-20
52323	SUPPL	2016-12-20
43350	SUPPL	2015-11-17
22833	SUPPL	2015-11-17
18971	SUPPL	2013-09-24
32041	SUPPL	2013-09-05
40035	SUPPL	2013-07-17
40033	SUPPL	2013-07-09
18970	SUPPL	2013-07-09
32040	SUPPL	2013-07-02
9835	SUPPL	2013-07-02
32039	SUPPL	2013-01-24
9836	SUPPL	2013-01-24
40034	SUPPL	2013-01-23
40032	SUPPL	2013-01-23
18969	SUPPL	2012-05-01
18968	SUPPL	2012-05-01
32038	SUPPL	2012-04-27
32037	SUPPL	2012-04-27
23954	ORIG	2011-12-22
40031	SUPPL	2011-12-13
40030	SUPPL	2011-12-13
9834	SUPPL	2011-12-13
9833	SUPPL	2011-12-13
44824	ORIG	2011-02-17
9832	SUPPL	2010-12-28
40029	SUPPL	2010-12-23
43349	ORIG	2010-12-03
9831	ORIG	2010-11-03
18967	ORIG	2010-10-29
66957	ORIG	1900-01-01
66956	ORIG	1900-01-01
63139	ORIG	1900-01-01
63138	SUPPL	1900-01-01
63136	SUPPL	1900-01-01
63135	SUPPL	1900-01-01
63134	SUPPL	1900-01-01
51320	SUPPL	1900-01-01
51319	SUPPL	1900-01-01
51318	SUPPL	1900-01-01