Application 210655

Type: NDA
Sponsor: INDIVIOR INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PERSERIS KIT	RISPERIDONE	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	90MG	Yes	No
002	PERSERIS KIT	RISPERIDONE	FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	120MG	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N210655-001	PERSERIS KIT	RISPERIDONE	90MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS		RLD	2018-07-27
N210655-002	PERSERIS KIT	RISPERIDONE	120MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS		RLD	2018-07-27

Orange Book patents#

Current patent rows page 1 of 1 · 20 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210655-001	10406160	2026-06-26	U-2608	Drug product	2019-09-26
N210655-001	10058554	2026-09-26	U-2363		2018-08-28
N210655-001	9597402	2026-09-26		Drug product	2018-07-31
N210655-001	11110093	2026-11-05	U-3135	Drug product	2021-09-07
N210655-001	10010612	2028-02-13		Drug product	2018-07-31
N210655-001	10376590	2028-02-13	U-2608		2019-08-29
N210655-001	11013809	2028-02-13	U-3135	Drug product	2021-07-01
N210655-001	11712475	2028-02-13	U-3135		2023-08-31
N210655-001	9180197	2028-02-13		Drug product	2018-07-31
N210655-001	9186413	2028-02-13	U-543		2018-07-31
N210655-002	10406160	2026-06-26	U-2608	Drug product	2019-09-26
N210655-002	10058554	2026-09-26	U-2363		2018-08-28
N210655-002	9597402	2026-09-26		Drug product	2018-07-31
N210655-002	11110093	2026-11-05	U-3135	Drug product	2021-09-07
N210655-002	10010612	2028-02-13		Drug product	2018-07-31
N210655-002	10376590	2028-02-13	U-2608		2019-08-29
N210655-002	11013809	2028-02-13	U-3135	Drug product	2021-07-01
N210655-002	11712475	2028-02-13	U-3135		2023-08-31
N210655-002	9180197	2028-02-13		Drug product	2018-07-31
N210655-002	9186413	2028-02-13	U-543		2018-07-31

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 · 82 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	N210655-001	PERSERIS KIT	90MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2018-07-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210655-002	PERSERIS KIT	120MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2018-07-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210655-001	PERSERIS KIT	90MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2018-07-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210655-002	PERSERIS KIT	120MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2018-07-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210655-001	PERSERIS KIT	90MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2018-07-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210655-002	PERSERIS KIT	120MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2018-07-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210655-001	PERSERIS KIT	90MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2018-07-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210655-002	PERSERIS KIT	120MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2018-07-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210655-001	PERSERIS KIT	90MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2018-07-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210655-002	PERSERIS KIT	120MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2018-07-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210655-001	PERSERIS KIT	90MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2018-07-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210655-002	PERSERIS KIT	120MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2018-07-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210655-001	PERSERIS KIT	90MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2018-07-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210655-002	PERSERIS KIT	120MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2018-07-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210655-001	PERSERIS KIT	90MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2018-07-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210655-002	PERSERIS KIT	120MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2018-07-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210655-001	PERSERIS KIT	90MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2018-07-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210655-002	PERSERIS KIT	120MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2018-07-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210655-001	PERSERIS KIT	90MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2018-07-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210655-002	PERSERIS KIT	120MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2018-07-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210655-001	PERSERIS KIT	90MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2018-07-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210655-002	PERSERIS KIT	120MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2018-07-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210655-001	PERSERIS KIT	90MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2018-07-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210655-002	PERSERIS KIT	120MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2018-07-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210655-001	PERSERIS KIT	90MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2018-07-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210655-002	PERSERIS KIT	120MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2018-07-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210655-001	PERSERIS KIT	90MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2018-07-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N210655-002	PERSERIS KIT	120MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2018-07-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210655-001	PERSERIS KIT	90MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2018-07-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210655-002	PERSERIS KIT	120MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2018-07-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210655-001	PERSERIS KIT	90MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2018-07-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210655-002	PERSERIS KIT	120MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2018-07-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210655-001	PERSERIS KIT	90MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2018-07-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210655-002	PERSERIS KIT	120MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2018-07-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210655-001	PERSERIS KIT	90MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2018-07-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N210655-002	PERSERIS KIT	120MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2018-07-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210655-001	PERSERIS KIT	90MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2018-07-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N210655-002	PERSERIS KIT	120MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2018-07-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210655-001	PERSERIS KIT	90MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2018-07-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N210655-002	PERSERIS KIT	120MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2018-07-27	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 19 · 740 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	N210655-001	10406160	2026-06-26	U-2608	Drug product	2019-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210655-001	10058554	2026-09-26	U-2363		2018-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210655-001	9597402	2026-09-26		Drug product	2018-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210655-001	11110093	2026-11-05	U-3135	Drug product	2021-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210655-001	10010612	2028-02-13		Drug product	2018-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210655-001	10376590	2028-02-13	U-2608		2019-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210655-001	11013809	2028-02-13	U-3135	Drug product	2021-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210655-001	11712475	2028-02-13	U-3135		2023-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210655-001	9180197	2028-02-13		Drug product	2018-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210655-001	9186413	2028-02-13	U-543		2018-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210655-002	10406160	2026-06-26	U-2608	Drug product	2019-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210655-002	10058554	2026-09-26	U-2363		2018-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210655-002	9597402	2026-09-26		Drug product	2018-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210655-002	11110093	2026-11-05	U-3135	Drug product	2021-09-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210655-002	10010612	2028-02-13		Drug product	2018-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210655-002	10376590	2028-02-13	U-2608		2019-08-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210655-002	11013809	2028-02-13	U-3135	Drug product	2021-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210655-002	11712475	2028-02-13	U-3135		2023-08-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210655-002	9180197	2028-02-13		Drug product	2018-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210655-002	9186413	2028-02-13	U-543		2018-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210655-001	10406160	2026-06-26	U-2608	Drug product	2019-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210655-001	10058554	2026-09-26	U-2363		2018-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210655-001	9597402	2026-09-26		Drug product	2018-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210655-001	11110093	2026-11-05	U-3135	Drug product	2021-09-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210655-001	10010612	2028-02-13		Drug product	2018-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210655-001	10376590	2028-02-13	U-2608		2019-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210655-001	11013809	2028-02-13	U-3135	Drug product	2021-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210655-001	11712475	2028-02-13	U-3135		2023-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210655-001	9180197	2028-02-13		Drug product	2018-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210655-001	9186413	2028-02-13	U-543		2018-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210655-002	10406160	2026-06-26	U-2608	Drug product	2019-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210655-002	10058554	2026-09-26	U-2363		2018-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210655-002	9597402	2026-09-26		Drug product	2018-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210655-002	11110093	2026-11-05	U-3135	Drug product	2021-09-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210655-002	10010612	2028-02-13		Drug product	2018-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210655-002	10376590	2028-02-13	U-2608		2019-08-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210655-002	11013809	2028-02-13	U-3135	Drug product	2021-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210655-002	11712475	2028-02-13	U-3135		2023-08-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210655-002	9180197	2028-02-13		Drug product	2018-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210655-002	9186413	2028-02-13	U-543		2018-07-31	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N210655-001	NP	2021-07-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N210655-002	NP	2021-07-27	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N210655-001	NP	2021-07-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N210655-002	NP	2021-07-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210655-001	NP	2021-07-27	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210655-002	NP	2021-07-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210655-001	NP	2021-07-27	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N210655-002	NP	2021-07-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210655-001	NP	2021-07-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N210655-002	NP	2021-07-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210655-001	NP	2021-07-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N210655-002	NP	2021-07-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N210655-001	NP	2021-07-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N210655-002	NP	2021-07-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N210655-001	NP	2021-07-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N210655-002	NP	2021-07-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N210655-001	NP	2021-07-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N210655-002	NP	2021-07-27	`ea99ee380514…`

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 4 · 72 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Risperidone	RISPERIDONE	Amneal Pharmaceuticals LLC	d526af85-ee70-4657-a27e-d451027ffd9e	2026-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RISPERIDONE
RISPERIDONE	RISPERIDONE	Coupler LLC	5643c32b-310e-4888-e063-6394a90ab62f	2026-07-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RISPERIDONE
Risperidone	RISPERIDONE	ATLANTIC BIOLOGICALS CORP.	dc8c6638-f487-49df-a265-78caa93e43d8	2026-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RISPERIDONE
RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	ee495f20-c668-4d8f-9684-1029a4f232db	2026-07-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RISPERIDONE
Risperidone	RISPERIDONE	Coupler LLC	55f3ebec-a742-48fc-e063-6394a90a1452	2026-07-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RISPERIDONE
Risperidone	RISPERIDONE	ANI Pharmaceuticals, Inc.	1f47ec91-602f-4fba-8f7e-a5698760b655	2026-06-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RISPERIDONE
RISPERIDONE	RISPERIDONE	REMEDYREPACK INC.	03d3b52d-3a7d-4595-84c9-332da6ca9171	2026-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RISPERIDONE
Risperidone	RISPERIDONE	Janssen Pharmaceutical, Inc.	701e1cd8-2868-4d29-85a9-a2212c88165f	2026-06-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RISPERIDONE
Risperidone	RISPERIDONE	REMEDYREPACK INC.	c84807bd-35d7-4138-8989-42617d69293a	2026-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RISPERIDONE
RISPERIDONE	RISPERIDONE	Coupler LLC	52bb35ac-1f7d-bfbe-e063-6294a90aa2b9	2026-06-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RISPERIDONE
RISPERDAL	RISPERIDONE	Janssen Pharmaceuticals, Inc.	7e117c7e-02fc-4343-92a1-230061dfc5e0	2026-05-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RISPERIDONE
Rykindo extended-release microspheres	RISPERIDONE	Shandong Luye Pharmaceutical Co., Ltd.	58534c96-96f5-4c2e-a061-92d4506aee91	2026-05-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RISPERIDONE
Risperidone	RISPERIDONE	PD-Rx Pharmaceuticals, Inc.	e72a2768-815f-47bf-b2f9-16a93dd10684	2026-04-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RISPERIDONE
Risperidone	RISPERIDONE	REMEDYREPACK INC.	8a4158fe-37d4-4c97-9c44-1c3489fe2a9f	2026-04-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RISPERIDONE
Risperidone	RISPERIDONE	REMEDYREPACK INC.	ab1cf6fd-9932-47fc-8736-476cc53a13fa	2026-04-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RISPERIDONE
risperidone	RISPERIDONE	Cardinal Health 107, LLC	3ce21196-4aa0-469b-8f04-6650b2c48cb5	2026-04-07	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RISPERIDONE
RISPERIDONE	RISPERIDONE	A-S Medication Solutions	a6767972-2d3f-482b-80bd-ac93e28fdd05	2026-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RISPERIDONE
Risperidone	RISPERIDONE	Solco Healthcare US, LLC	43aa2a4f-1123-4f86-800b-9218882f7bcd	2026-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RISPERIDONE
Risperidone	RISPERIDONE	Amici Pharma, Inc.	ca41c144-224a-4d57-88d7-8778e6c69ed2	2026-03-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RISPERIDONE
RISPERIDONE	RISPERIDONE	PD-Rx Pharmaceuticals, Inc.	bdb08381-dbfc-442e-8d3c-22d3a0f2f6c5	2026-03-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RISPERIDONE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
12496-0090	PERSERIS	Risperidone	Indivior Inc.	NDA	Current
12496-0090	PERSERIS	Risperidone	Indivior Inc.	NDA	Current
12496-0090	PERSERIS	Risperidone	Indivior Inc.	NDA	Current
12496-0090	PERSERIS	Risperidone	Indivior Inc.	NDA	Current
12496-0090	PERSERIS	Risperidone	Indivior Inc.	NDA	Current
12496-0090	PERSERIS	Risperidone	Indivior Inc.	NDA	Current
12496-0090	PERSERIS	Risperidone	Indivior Inc.	NDA	Current
12496-0090	PERSERIS	Risperidone	Indivior Inc.	NDA	Current
12496-0120	PERSERIS	Risperidone	Indivior Inc.	NDA	Current
12496-0120	PERSERIS	Risperidone	Indivior Inc.	NDA	Current
12496-0120	PERSERIS	Risperidone	Indivior Inc.	NDA	Current
12496-0120	PERSERIS	Risperidone	Indivior Inc.	NDA	Current
12496-0120	PERSERIS	Risperidone	Indivior Inc.	NDA	Current
12496-0120	PERSERIS	Risperidone	Indivior Inc.	NDA	Current
12496-0120	PERSERIS	Risperidone	Indivior Inc.	NDA	Current
12496-0120	PERSERIS	Risperidone	Indivior Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81089	SUPPL	2025-02-06
80981	SUPPL	2025-02-05
73004	SUPPL	2022-12-22
72915	SUPPL	2022-12-16
72558	SUPPL	2022-11-03
61804	SUPPL	2020-02-06
61789	SUPPL	2020-02-06
55125	ORIG	2018-08-07
55085	ORIG	2018-08-03
58697	ORIG	2018-07-27