Application 209500

Type: NDA
Sponsor: INTRA-CELLULAR

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CAPLYTA	LUMATEPERONE TOSYLATE	CAPSULE;ORAL	EQ 42MG BASE	Yes	Yes
002	CAPLYTA	LUMATEPERONE TOSYLATE	CAPSULE;ORAL	EQ 10.5MG BASE	Yes	No
003	CAPLYTA	LUMATEPERONE TOSYLATE	CAPSULE;ORAL	EQ 21MG BASE	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	RLD / RS	Approval date
N209500-001	CAPLYTA	LUMATEPERONE TOSYLATE	EQ 42MG BASE	CAPSULE / ORAL	RLD, RS	2019-12-20
N209500-002	CAPLYTA	LUMATEPERONE TOSYLATE	EQ 10.5MG BASE	CAPSULE / ORAL	RLD	2022-04-22
N209500-003	CAPLYTA	LUMATEPERONE TOSYLATE	EQ 21MG BASE	CAPSULE / ORAL	RLD	2022-04-22

Orange Book patents#

Current patent rows page 1 of 2 · 97 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209500-001	10464938	2028-03-12		Drug product	2020-01-17
N209500-001	9199995	2029-03-12	U-2713		2020-01-17
N209500-001	9199995	2029-03-12	U-4343		2020-01-17
N209500-001	9586960	2029-03-12		Drug substance, Drug product	2020-01-17
N209500-001	RE48825	2029-03-12		Drug substance, Drug product	2021-12-21
N209500-001	10117867	2029-05-27	U-3271		2022-01-13
N209500-001	9616061	2029-05-27		Drug product	2020-01-17
N209500-001	8648077	2029-12-01		Drug substance, Drug product	2020-01-17
N209500-001	8598119	2029-12-28	U-543	Delist requested	2020-01-17
N209500-001	RE48839	2033-08-19	U-3271		2022-01-05
N209500-001	RE48839	2033-08-19	U-4344		2022-01-05
N209500-001	RE48839	2033-08-19	U-814		2022-01-05
N209500-001	10960009	2034-12-03	U-814		2021-04-20
N209500-001	11026951	2034-12-03	U-3274		2022-01-13
N209500-001	9956227	2034-12-03	U-2714		2020-01-17
N209500-001	12409176	2039-03-15	U-4261		2025-09-17
N209500-001	10695345	2039-08-30	U-543	Drug product	2020-07-16
N209500-001	11690842	2039-08-30	U-3362	Drug product	2023-08-03
N209500-001	11690842	2039-08-30	U-3363	Drug product	2023-08-03
N209500-001	11690842	2039-08-30	U-4341	Drug product	2023-08-03
N209500-001	11806348	2039-08-30	U-3362	Drug product	2023-11-17
N209500-001	11806348	2039-08-30	U-3363	Drug product	2023-11-17
N209500-001	11806348	2039-08-30	U-4341	Drug product	2023-11-17
N209500-001	12070459	2039-08-30	U-3362	Drug product	2024-08-29
N209500-001	12070459	2039-08-30	U-3363	Drug product	2024-08-29
N209500-001	12070459	2039-08-30	U-4341	Drug product	2024-08-29
N209500-001	12128043	2039-08-30	U-3362	Drug product	2024-10-30
N209500-001	12128043	2039-08-30	U-3363	Drug product	2024-10-30
N209500-001	11980617	2039-10-27	U-3940		2024-06-11
N209500-001	11980617	2039-10-27	U-4342		2024-06-11
N209500-001	12090155	2040-07-07	U-4000	Drug product	2024-10-04
N209500-001	11753419	2040-12-10		Drug product, Delist requested	2023-10-11
N209500-001	12122792	2040-12-10	U-4019	Drug product	2024-10-28
N209500-001	12122792	2040-12-10	U-4020	Drug product	2024-10-28
N209500-001	12122792	2040-12-10	U-4340	Drug product	2024-10-28
N209500-001	12410195	2040-12-10		Drug product	2025-09-17
N209500-002	10464938	2028-03-12		Drug product	2022-05-18
N209500-002	9199995	2029-03-12	U-2713		2022-05-18
N209500-002	9199995	2029-03-12	U-4343		2022-05-18
N209500-002	RE48825	2029-03-12		Drug substance	2022-05-18
N209500-002	10117867	2029-05-27	U-3271		2022-05-18
N209500-002	9168258	2029-05-27		Drug product	2023-12-12
N209500-002	9616061	2029-05-27		Drug product	2022-05-18
N209500-002	8648077	2029-12-01		Drug substance, Drug product	2022-05-18
N209500-002	RE48839	2033-08-19	U-3271		2022-05-18
N209500-002	RE48839	2033-08-19	U-4344		2022-05-18
N209500-002	RE48839	2033-08-19	U-814		2022-05-18
N209500-002	11026951	2034-12-03	U-3364		2022-05-18
N209500-002	9956227	2034-12-03	U-2714		2022-05-18
N209500-002	12409176	2039-03-15	U-4261		2025-09-17
N209500-002	10695345	2039-08-30	U-814	Drug product	2022-05-18
N209500-002	11052084	2039-08-30	U-3362	Drug product	2022-05-18
N209500-002	11052084	2039-08-30	U-3363	Drug product	2022-05-18
N209500-002	11052084	2039-08-30	U-4341	Drug product	2022-05-18
N209500-002	11690842	2039-08-30	U-3362	Drug product	2023-08-03
N209500-002	11690842	2039-08-30	U-3363	Drug product	2023-08-03
N209500-002	11690842	2039-08-30	U-4341	Drug product	2023-08-03
N209500-002	11806348	2039-08-30	U-3362	Drug product	2023-11-17
N209500-002	11806348	2039-08-30	U-3363	Drug product	2023-11-17
N209500-002	11806348	2039-08-30	U-4341	Drug product	2023-11-17
N209500-002	11980617	2039-10-27	U-3940		2024-06-11
N209500-002	11980617	2039-10-27	U-4342		2024-06-11
N209500-002	11753419	2040-12-10		Drug product, Delist requested	2023-10-11
N209500-002	12122792	2040-12-10	U-4019	Drug product	2024-10-28
N209500-002	12122792	2040-12-10	U-4020	Drug product	2024-10-28
N209500-002	12122792	2040-12-10	U-4340	Drug product	2024-10-28
N209500-002	12410195	2040-12-10		Drug product	2025-09-17
N209500-003	10464938	2028-03-12		Drug product	2022-05-18
N209500-003	9199995	2029-03-12	U-2713		2022-05-18
N209500-003	9199995	2029-03-12	U-4343		2022-05-18
N209500-003	RE48825	2029-03-12		Drug substance	2022-05-18
N209500-003	10117867	2029-05-27	U-3271		2022-05-18
N209500-003	9616061	2029-05-27		Drug product	2022-05-18
N209500-003	8648077	2029-12-01		Drug substance, Drug product	2022-05-18
N209500-003	RE48839	2033-08-19	U-3271		2022-05-18
N209500-003	RE48839	2033-08-19	U-4344		2022-05-18
N209500-003	RE48839	2033-08-19	U-814		2022-05-18
N209500-003	11026951	2034-12-03	U-3364		2022-05-18
N209500-003	9956227	2034-12-03	U-2714		2022-05-18
N209500-003	12409176	2039-03-15	U-4261		2025-09-17

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N209500-001	I-904	2028-11-05
N209500-001	M-319	2029-04-24
N209500-002	I-904	2028-11-05
N209500-002	M-319	2029-04-24
N209500-003	I-904	2028-11-05
N209500-003	M-319	2029-04-24

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 3 · 101 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N209500-001	CAPLYTA	EQ 42MG BASE	CAPSULE / ORAL	RLD, RS	2019-12-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-002	CAPLYTA	EQ 10.5MG BASE	CAPSULE / ORAL	RLD	2022-04-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-003	CAPLYTA	EQ 21MG BASE	CAPSULE / ORAL	RLD	2022-04-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209500-001	CAPLYTA	EQ 42MG BASE	CAPSULE / ORAL	RLD, RS	2019-12-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209500-002	CAPLYTA	EQ 10.5MG BASE	CAPSULE / ORAL	RLD	2022-04-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209500-003	CAPLYTA	EQ 21MG BASE	CAPSULE / ORAL	RLD	2022-04-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209500-001	CAPLYTA	EQ 42MG BASE	CAPSULE / ORAL	RLD, RS	2019-12-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209500-002	CAPLYTA	EQ 10.5MG BASE	CAPSULE / ORAL	RLD	2022-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209500-003	CAPLYTA	EQ 21MG BASE	CAPSULE / ORAL	RLD	2022-04-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209500-001	CAPLYTA	EQ 42MG BASE	CAPSULE / ORAL	RLD, RS	2019-12-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209500-002	CAPLYTA	EQ 10.5MG BASE	CAPSULE / ORAL	RLD	2022-04-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209500-003	CAPLYTA	EQ 21MG BASE	CAPSULE / ORAL	RLD	2022-04-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209500-001	CAPLYTA	EQ 42MG BASE	CAPSULE / ORAL	RLD, RS	2019-12-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209500-002	CAPLYTA	EQ 10.5MG BASE	CAPSULE / ORAL	RLD	2022-04-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209500-003	CAPLYTA	EQ 21MG BASE	CAPSULE / ORAL	RLD	2022-04-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209500-001	CAPLYTA	EQ 42MG BASE	CAPSULE / ORAL	RLD, RS	2019-12-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209500-002	CAPLYTA	EQ 10.5MG BASE	CAPSULE / ORAL	RLD	2022-04-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209500-003	CAPLYTA	EQ 21MG BASE	CAPSULE / ORAL	RLD	2022-04-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209500-001	CAPLYTA	EQ 42MG BASE	CAPSULE / ORAL	RLD, RS	2019-12-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209500-002	CAPLYTA	EQ 10.5MG BASE	CAPSULE / ORAL	RLD	2022-04-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209500-003	CAPLYTA	EQ 21MG BASE	CAPSULE / ORAL	RLD	2022-04-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209500-001	CAPLYTA	EQ 42MG BASE	CAPSULE / ORAL	RLD, RS	2019-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209500-002	CAPLYTA	EQ 10.5MG BASE	CAPSULE / ORAL	RLD	2022-04-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209500-003	CAPLYTA	EQ 21MG BASE	CAPSULE / ORAL	RLD	2022-04-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209500-001	CAPLYTA	EQ 42MG BASE	CAPSULE / ORAL	RLD, RS	2019-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209500-002	CAPLYTA	EQ 10.5MG BASE	CAPSULE / ORAL	RLD	2022-04-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209500-003	CAPLYTA	EQ 21MG BASE	CAPSULE / ORAL	RLD	2022-04-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209500-001	CAPLYTA	EQ 42MG BASE	CAPSULE / ORAL	RLD, RS	2019-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209500-002	CAPLYTA	EQ 10.5MG BASE	CAPSULE / ORAL	RLD	2022-04-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209500-003	CAPLYTA	EQ 21MG BASE	CAPSULE / ORAL	RLD	2022-04-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209500-001	CAPLYTA	EQ 42MG BASE	CAPSULE / ORAL	RLD, RS	2019-12-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209500-002	CAPLYTA	EQ 10.5MG BASE	CAPSULE / ORAL	RLD	2022-04-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209500-003	CAPLYTA	EQ 21MG BASE	CAPSULE / ORAL	RLD	2022-04-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209500-001	CAPLYTA	EQ 42MG BASE	CAPSULE / ORAL	RLD, RS	2019-12-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209500-002	CAPLYTA	EQ 10.5MG BASE	CAPSULE / ORAL	RLD	2022-04-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209500-003	CAPLYTA	EQ 21MG BASE	CAPSULE / ORAL	RLD	2022-04-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209500-001	CAPLYTA	EQ 42MG BASE	CAPSULE / ORAL	RLD, RS	2019-12-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209500-002	CAPLYTA	EQ 10.5MG BASE	CAPSULE / ORAL	RLD	2022-04-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209500-003	CAPLYTA	EQ 21MG BASE	CAPSULE / ORAL	RLD	2022-04-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209500-001	CAPLYTA	EQ 42MG BASE	CAPSULE / ORAL	RLD, RS	2019-12-20	`301d65b070ca…`

Observed Orange Book patent history#

Patent history page 1 of 50 · 1,973 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N209500-001	10464938	2028-03-12		Drug product	2020-01-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-001	9199995	2029-03-12	U-2713		2020-01-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-001	9199995	2029-03-12	U-4343		2020-01-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-001	9586960	2029-03-12		Drug substance, Drug product	2020-01-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-001	RE48825	2029-03-12		Drug substance, Drug product	2021-12-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-001	10117867	2029-05-27	U-3271		2022-01-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-001	9616061	2029-05-27		Drug product	2020-01-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-001	8648077	2029-12-01		Drug substance, Drug product	2020-01-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-001	8598119	2029-12-28	U-543	Delist requested	2020-01-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-001	RE48839	2033-08-19	U-4344		2022-01-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-001	RE48839	2033-08-19	U-3271		2022-01-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-001	RE48839	2033-08-19	U-814		2022-01-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-001	10960009	2034-12-03	U-814		2021-04-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-001	11026951	2034-12-03	U-3274		2022-01-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-001	9956227	2034-12-03	U-2714		2020-01-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-001	12409176	2039-03-15	U-4261		2025-09-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-001	10695345	2039-08-30	U-543	Drug product	2020-07-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-001	11690842	2039-08-30	U-4341	Drug product	2023-08-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-001	11690842	2039-08-30	U-3362	Drug product	2023-08-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-001	11690842	2039-08-30	U-3363	Drug product	2023-08-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-001	11806348	2039-08-30	U-3362	Drug product	2023-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-001	11806348	2039-08-30	U-3363	Drug product	2023-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-001	11806348	2039-08-30	U-4341	Drug product	2023-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-001	12070459	2039-08-30	U-3362	Drug product	2024-08-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-001	12070459	2039-08-30	U-3363	Drug product	2024-08-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-001	12070459	2039-08-30	U-4341	Drug product	2024-08-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-001	12128043	2039-08-30	U-3362	Drug product	2024-10-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-001	12128043	2039-08-30	U-3363	Drug product	2024-10-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-001	11980617	2039-10-27	U-4342		2024-06-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-001	11980617	2039-10-27	U-3940		2024-06-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-001	12090155	2040-07-07	U-4000	Drug product	2024-10-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-001	11753419	2040-12-10		Drug product, Delist requested	2023-10-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-001	12122792	2040-12-10	U-4019	Drug product	2024-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-001	12122792	2040-12-10	U-4020	Drug product	2024-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-001	12122792	2040-12-10	U-4340	Drug product	2024-10-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-001	12410195	2040-12-10		Drug product	2025-09-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-002	10464938	2028-03-12		Drug product	2022-05-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-002	9199995	2029-03-12	U-4343		2022-05-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-002	9199995	2029-03-12	U-2713		2022-05-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-002	RE48825	2029-03-12		Drug substance	2022-05-18	`84e616aacf4f…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 127 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N209500-001	I-904	2028-11-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-001	M-319	2029-04-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-002	I-904	2028-11-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-002	M-319	2029-04-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-003	I-904	2028-11-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209500-003	M-319	2029-04-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209500-001	I-904	2028-11-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209500-001	M-319	2029-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209500-002	I-904	2028-11-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209500-002	M-319	2029-04-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209500-003	I-904	2028-11-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209500-003	M-319	2029-04-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209500-001	I-904	2028-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209500-002	I-904	2028-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209500-003	I-904	2028-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209500-001	I-904	2028-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209500-002	I-904	2028-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209500-003	I-904	2028-11-05	`31067a03dcf5…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209500-001	I-882	2024-12-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209500-001	NCE	2024-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209500-002	NCE	2024-12-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209500-003	NCE	2024-12-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209500-001	I-882	2024-12-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209500-001	NCE	2024-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209500-002	NCE	2024-12-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209500-003	NCE	2024-12-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209500-001	I-882	2024-12-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209500-001	NCE	2024-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209500-002	NCE	2024-12-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209500-003	NCE	2024-12-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209500-001	I-882	2024-12-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209500-001	NCE	2024-12-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209500-002	NCE	2024-12-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209500-003	NCE	2024-12-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209500-001	I-882	2024-12-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209500-001	NCE	2024-12-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209500-002	NCE	2024-12-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209500-003	NCE	2024-12-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209500-001	I-882	2024-12-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209500-001	NCE	2024-12-20	`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
CAPLYTA	LUMATEPERONE	Intra-Cellular Therapies, Inc	db730b06-6351-47fd-8183-e61e61bbead5	2025-06-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 209500 application number: NDA209500 ndc (product): 72060-142 ndc (product): 72060-121 ndc (product): 72060-110

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 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70518-3497	CAPLYTA	lumateperone	REMEDYREPACK INC.	NDA	Current
72060-110	CAPLYTA	lumateperone	Intra-Cellular Therapies, Inc	NDA	Current
72060-110	CAPLYTA	lumateperone	Intra-Cellular Therapies, Inc	NDA	Current
72060-121	CAPLYTA	lumateperone	Intra-Cellular Therapies, Inc	NDA	Current
72060-121	CAPLYTA	lumateperone	Intra-Cellular Therapies, Inc	NDA	Current
72060-142	CAPLYTA	lumateperone	Intra-Cellular Therapies, Inc	NDA	Current
72060-142	CAPLYTA	lumateperone	Intra-Cellular Therapies, Inc	NDA	Current
72060-142	CAPLYTA	lumateperone	Intra-Cellular Therapies, Inc	NDA	Current
72060-142	CAPLYTA	lumateperone	Intra-Cellular Therapies, Inc	NDA	Current
72060-142	CAPLYTA	lumateperone	Intra-Cellular Therapies, Inc	NDA	Current
72060-142	CAPLYTA	lumateperone	Intra-Cellular Therapies, Inc	NDA	Current
72060-142	CAPLYTA	lumateperone	Intra-Cellular Therapies, Inc	NDA	Current
72060-142	CAPLYTA	lumateperone	Intra-Cellular Therapies, Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85775	SUPPL	2026-04-28
85771	SUPPL	2026-04-27
84120	SUPPL	2025-11-06
84119	SUPPL	2025-11-06
84091	SUPPL	2025-11-06
74660	SUPPL	2023-06-29
74654	SUPPL	2023-06-29
70835	SUPPL	2022-04-27
70834	SUPPL	2022-04-27
70725	SUPPL	2022-04-07
70724	SUPPL	2022-04-07
69719	SUPPL	2021-12-21
69718	SUPPL	2021-12-21
69644	SUPPL	2021-12-19
69643	SUPPL	2021-12-19
69642	SUPPL	2021-12-19
61607	ORIG	2020-01-21
61606	ORIG	2020-01-21
61400	SUPPL	2019-12-23
61374	SUPPL	2019-12-23