Application 212268

Type: NDA
Sponsor: HISAMITSU

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SECUADO	ASENAPINE	SYSTEM;TRANSDERMAL	3.8MG/24HR	Yes	No
002	SECUADO	ASENAPINE	SYSTEM;TRANSDERMAL	5.7MG/24HR	Yes	No
003	SECUADO	ASENAPINE	SYSTEM;TRANSDERMAL	7.6MG/24HR	Yes	Yes

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

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
N212268-001	SECUADO	ASENAPINE	3.8MG/24HR	SYSTEM / TRANSDERMAL	RLD, RS	2019-10-11
N212268-002	SECUADO	ASENAPINE	5.7MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11
N212268-003	SECUADO	ASENAPINE	7.6MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N212268-001	10022445	2033-07-25		Drug product	2019-10-18
N212268-001	10583121	2033-07-25	U-2763	Drug product	2020-03-27
N212268-001	10814002	2033-07-25	U-2763	Drug product	2020-11-13
N212268-001	11123305	2033-07-25		Drug product	2021-10-21
N212268-001	9687474	2033-07-25		Drug product	2019-10-18
N212268-001	11813364	2033-09-22		Drug product	2023-12-11
N212268-002	10022445	2033-07-25		Drug product	2019-10-18
N212268-002	10583121	2033-07-25	U-2763	Drug product	2020-03-27
N212268-002	10814002	2033-07-25	U-2763	Drug product	2020-11-13
N212268-002	11123305	2033-07-25		Drug product	2021-10-21
N212268-002	9687474	2033-07-25		Drug product	2019-10-18
N212268-002	11813364	2033-09-22		Drug product	2023-12-11
N212268-003	10022445	2033-07-25		Drug product	2019-10-18
N212268-003	10583121	2033-07-25	U-2763	Drug product	2020-03-27
N212268-003	10814002	2033-07-25	U-2763	Drug product	2020-11-13
N212268-003	11123305	2033-07-25		Drug product	2021-10-21
N212268-003	9687474	2033-07-25		Drug product	2019-10-18
N212268-003	11813364	2033-09-22		Drug product	2023-12-11

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 · 117 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	N212268-001	SECUADO	3.8MG/24HR	SYSTEM / TRANSDERMAL	RLD, RS	2019-10-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212268-002	SECUADO	5.7MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212268-003	SECUADO	7.6MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212268-001	SECUADO	3.8MG/24HR	SYSTEM / TRANSDERMAL	RLD, RS	2019-10-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212268-002	SECUADO	5.7MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212268-003	SECUADO	7.6MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212268-001	SECUADO	3.8MG/24HR	SYSTEM / TRANSDERMAL	RLD, RS	2019-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212268-002	SECUADO	5.7MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212268-003	SECUADO	7.6MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212268-001	SECUADO	3.8MG/24HR	SYSTEM / TRANSDERMAL	RLD, RS	2019-10-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212268-002	SECUADO	5.7MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212268-003	SECUADO	7.6MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212268-001	SECUADO	3.8MG/24HR	SYSTEM / TRANSDERMAL	RLD, RS	2019-10-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212268-002	SECUADO	5.7MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212268-003	SECUADO	7.6MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212268-001	SECUADO	3.8MG/24HR	SYSTEM / TRANSDERMAL	RLD, RS	2019-10-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212268-002	SECUADO	5.7MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212268-003	SECUADO	7.6MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212268-001	SECUADO	3.8MG/24HR	SYSTEM / TRANSDERMAL	RLD, RS	2019-10-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212268-002	SECUADO	5.7MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212268-003	SECUADO	7.6MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212268-001	SECUADO	3.8MG/24HR	SYSTEM / TRANSDERMAL	RLD, RS	2019-10-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212268-002	SECUADO	5.7MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212268-003	SECUADO	7.6MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212268-001	SECUADO	3.8MG/24HR	SYSTEM / TRANSDERMAL	RLD, RS	2019-10-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212268-002	SECUADO	5.7MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212268-003	SECUADO	7.6MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212268-001	SECUADO	3.8MG/24HR	SYSTEM / TRANSDERMAL	RLD, RS	2019-10-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212268-002	SECUADO	5.7MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212268-003	SECUADO	7.6MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212268-001	SECUADO	3.8MG/24HR	SYSTEM / TRANSDERMAL	RLD, RS	2019-10-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212268-002	SECUADO	5.7MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212268-003	SECUADO	7.6MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212268-001	SECUADO	3.8MG/24HR	SYSTEM / TRANSDERMAL	RLD, RS	2019-10-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212268-002	SECUADO	5.7MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212268-003	SECUADO	7.6MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212268-001	SECUADO	3.8MG/24HR	SYSTEM / TRANSDERMAL	RLD, RS	2019-10-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212268-002	SECUADO	5.7MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212268-003	SECUADO	7.6MG/24HR	SYSTEM / TRANSDERMAL	RLD	2019-10-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212268-001	SECUADO	3.8MG/24HR	SYSTEM / TRANSDERMAL	RLD, RS	2019-10-11	`8072bd15b7f6…`

Observed Orange Book patent history#

Patent history page 1 of 16 · 603 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	N212268-001	10022445	2033-07-25		Drug product	2019-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212268-001	10583121	2033-07-25	U-2763	Drug product	2020-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212268-001	10814002	2033-07-25	U-2763	Drug product	2020-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212268-001	11123305	2033-07-25		Drug product	2021-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212268-001	9687474	2033-07-25		Drug product	2019-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212268-001	11813364	2033-09-22		Drug product	2023-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212268-002	10022445	2033-07-25		Drug product	2019-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212268-002	10583121	2033-07-25	U-2763	Drug product	2020-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212268-002	10814002	2033-07-25	U-2763	Drug product	2020-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212268-002	11123305	2033-07-25		Drug product	2021-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212268-002	9687474	2033-07-25		Drug product	2019-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212268-002	11813364	2033-09-22		Drug product	2023-12-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212268-003	10022445	2033-07-25		Drug product	2019-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212268-003	10583121	2033-07-25	U-2763	Drug product	2020-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212268-003	10814002	2033-07-25	U-2763	Drug product	2020-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212268-003	11123305	2033-07-25		Drug product	2021-10-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212268-003	9687474	2033-07-25		Drug product	2019-10-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212268-003	11813364	2033-09-22		Drug product	2023-12-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212268-001	10022445	2033-07-25		Drug product	2019-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212268-001	10583121	2033-07-25	U-2763	Drug product	2020-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212268-001	10814002	2033-07-25	U-2763	Drug product	2020-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212268-001	11123305	2033-07-25		Drug product	2021-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212268-001	9687474	2033-07-25		Drug product	2019-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212268-001	11813364	2033-09-22		Drug product	2023-12-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212268-002	10022445	2033-07-25		Drug product	2019-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212268-002	10583121	2033-07-25	U-2763	Drug product	2020-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212268-002	10814002	2033-07-25	U-2763	Drug product	2020-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212268-002	11123305	2033-07-25		Drug product	2021-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212268-002	9687474	2033-07-25		Drug product	2019-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212268-002	11813364	2033-09-22		Drug product	2023-12-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212268-003	10022445	2033-07-25		Drug product	2019-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212268-003	10583121	2033-07-25	U-2763	Drug product	2020-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212268-003	10814002	2033-07-25	U-2763	Drug product	2020-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212268-003	11123305	2033-07-25		Drug product	2021-10-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212268-003	9687474	2033-07-25		Drug product	2019-10-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212268-003	11813364	2033-09-22		Drug product	2023-12-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212268-001	10022445	2033-07-25		Drug product	2019-10-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212268-001	10583121	2033-07-25	U-2763	Drug product	2020-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212268-001	10814002	2033-07-25	U-2763	Drug product	2020-11-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212268-001	11123305	2033-07-25		Drug product	2021-10-21	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212268-001	NP	2022-10-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212268-002	NP	2022-10-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212268-003	NP	2022-10-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212268-001	NP	2022-10-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N212268-002	NP	2022-10-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N212268-003	NP	2022-10-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212268-001	NP	2022-10-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N212268-002	NP	2022-10-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N212268-003	NP	2022-10-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N212268-001	NP	2022-10-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N212268-002	NP	2022-10-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N212268-003	NP	2022-10-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N212268-001	NP	2022-10-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N212268-002	NP	2022-10-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N212268-003	NP	2022-10-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N212268-001	NP	2022-10-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N212268-002	NP	2022-10-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N212268-003	NP	2022-10-11	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212268-001	NP	2022-10-11	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212268-002	NP	2022-10-11	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212268-003	NP	2022-10-11	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N212268-001	NP	2022-10-11	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N212268-002	NP	2022-10-11	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N212268-003	NP	2022-10-11	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N212268-001	NP	2022-10-11	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N212268-002	NP	2022-10-11	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N212268-003	NP	2022-10-11	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N212268-001	NP	2022-10-11	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N212268-002	NP	2022-10-11	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N212268-003	NP	2022-10-11	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N212268-001	NP	2022-10-11	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N212268-002	NP	2022-10-11	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N212268-003	NP	2022-10-11	`3f01610625f2…`
2023-01-26 05:58 UTC	2023-01	N212268-001	NP	2022-10-11	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N212268-002	NP	2022-10-11	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N212268-003	NP	2022-10-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N212268-001	NP	2022-10-11	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N212268-002	NP	2022-10-11	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N212268-003	NP	2022-10-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N212268-001	NP	2022-10-11	`f41ea6bd6efb…`

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
SECUADO	ASENAPINE	Noven Therapeutics, LLC	685eaf44-5944-4f38-afba-0a4fc0b3462b	2025-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 212268 application number: NDA212268 ndc (product): 68968-0172 ndc (product): 68968-0174 ndc (product): 68968-0173

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68968-0172	SECUADO	ASENAPINE	Noven Therapeutics, LLC	NDA	Current
68968-0172	SECUADO	ASENAPINE	Noven Therapeutics, LLC	NDA	Current
68968-0172	SECUADO	ASENAPINE	Noven Therapeutics, LLC	NDA	Current
68968-0172	SECUADO	ASENAPINE	Noven Therapeutics, LLC	NDA	Current
68968-0173	SECUADO	ASENAPINE	Noven Therapeutics, LLC	NDA	Current
68968-0173	SECUADO	ASENAPINE	Noven Therapeutics, LLC	NDA	Current
68968-0173	SECUADO	ASENAPINE	Noven Therapeutics, LLC	NDA	Current
68968-0173	SECUADO	ASENAPINE	Noven Therapeutics, LLC	NDA	Current
68968-0174	SECUADO	ASENAPINE	Noven Therapeutics, LLC	NDA	Current
68968-0174	SECUADO	ASENAPINE	Noven Therapeutics, LLC	NDA	Current
68968-0174	SECUADO	ASENAPINE	Noven Therapeutics, LLC	NDA	Current
68968-0174	SECUADO	ASENAPINE	Noven Therapeutics, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81164	SUPPL	2025-02-07
80934	SUPPL	2025-02-05
61641	ORIG	2020-01-24
60609	ORIG	2019-10-21
60562	ORIG	2019-10-15