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 43.

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 · 86 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	N210655-001	PERSERIS KIT	90MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2018-07-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210655-002	PERSERIS KIT	120MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2018-07-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N210655-001	PERSERIS KIT	90MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2018-07-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210655-002	PERSERIS KIT	120MG	FOR SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2018-07-27	`caaa826d4ba7…`
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…`

Observed Orange Book patent history#

Patent history page 1 of 20 · 780 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	N210655-001	10406160	2026-06-26	U-2608	Drug product	2019-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210655-001	10058554	2026-09-26	U-2363		2018-08-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210655-001	9597402	2026-09-26		Drug product	2018-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210655-001	11110093	2026-11-05	U-3135	Drug product	2021-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210655-001	10010612	2028-02-13		Drug product	2018-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210655-001	10376590	2028-02-13	U-2608		2019-08-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210655-001	11013809	2028-02-13	U-3135	Drug product	2021-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210655-001	11712475	2028-02-13	U-3135		2023-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210655-001	9180197	2028-02-13		Drug product	2018-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210655-001	9186413	2028-02-13	U-543		2018-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210655-002	10406160	2026-06-26	U-2608	Drug product	2019-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210655-002	10058554	2026-09-26	U-2363		2018-08-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210655-002	9597402	2026-09-26		Drug product	2018-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210655-002	11110093	2026-11-05	U-3135	Drug product	2021-09-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210655-002	10010612	2028-02-13		Drug product	2018-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210655-002	10376590	2028-02-13	U-2608		2019-08-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210655-002	11013809	2028-02-13	U-3135	Drug product	2021-07-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210655-002	11712475	2028-02-13	U-3135		2023-08-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210655-002	9180197	2028-02-13		Drug product	2018-07-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N210655-002	9186413	2028-02-13	U-543		2018-07-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N210655-001	10406160	2026-06-26	U-2608	Drug product	2019-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210655-001	10058554	2026-09-26	U-2363		2018-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210655-001	9597402	2026-09-26		Drug product	2018-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210655-001	11110093	2026-11-05	U-3135	Drug product	2021-09-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210655-001	10010612	2028-02-13		Drug product	2018-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210655-001	10376590	2028-02-13	U-2608		2019-08-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210655-001	11013809	2028-02-13	U-3135	Drug product	2021-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210655-001	11712475	2028-02-13	U-3135		2023-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210655-001	9180197	2028-02-13		Drug product	2018-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210655-001	9186413	2028-02-13	U-543		2018-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210655-002	10406160	2026-06-26	U-2608	Drug product	2019-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210655-002	10058554	2026-09-26	U-2363		2018-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210655-002	9597402	2026-09-26		Drug product	2018-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210655-002	11110093	2026-11-05	U-3135	Drug product	2021-09-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210655-002	10010612	2028-02-13		Drug product	2018-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210655-002	10376590	2028-02-13	U-2608		2019-08-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210655-002	11013809	2028-02-13	U-3135	Drug product	2021-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210655-002	11712475	2028-02-13	U-3135		2023-08-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210655-002	9180197	2028-02-13		Drug product	2018-07-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210655-002	9186413	2028-02-13	U-543		2018-07-31	`caaa826d4ba7…`

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 3 of 4 · 71 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
risperidone	RISPERIDONE	Zydus Pharmaceuticals USA Inc.	713b5ac7-53d6-4139-8599-3028f789de4b	2025-06-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RISPERIDONE
Risperidone	RISPERIDONE	Bryant Ranch Prepack	684dcda4-d270-400c-9798-7d920a038bbb	2025-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RISPERIDONE
Risperidone	RISPERIDONE	Cranbury Pharmaceuticals, LLC	a0a21bec-68f0-444e-a611-d0602859410c	2025-05-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RISPERIDONE
RISPERIDONE	RISPERIDONE	PD-Rx Pharmaceuticals, Inc.	be388943-fe0c-4c82-ac8e-3df9f77b2891	2025-04-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RISPERIDONE
Risperidone	RISPERIDONE	Bryant Ranch Prepack	3cc027f0-3462-4a2f-925b-d8a529bcb3c3	2025-03-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RISPERIDONE
Risperidone	RISPERIDONE	AvKARE	2f9ea0cc-b86b-a11f-e063-6294a90a9620	2025-03-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RISPERIDONE
RISPERIDONE	RISPERIDONE	Aurobindo Pharma Limited	c4582bdf-5eda-438c-98b4-0517500501e8	2025-03-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RISPERIDONE
Risperidone	RISPERIDONE	Teva Pharmaceuticals, Inc.	32c0f081-b418-4c1c-b39e-eb5c344043c7	2025-02-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RISPERIDONE
Risperidone	RISPERIDONE	Amneal Pharmaceuticals NY LLC	e90c886c-132a-4df6-8604-cfe5ffa49d5b	2025-02-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RISPERIDONE
Risperidone	RISPERIDONE	Amneal Pharmaceuticals LLC	bc55f60a-8121-44bb-bdfc-1d311879ba4f	2025-02-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RISPERIDONE
Risperidone	RISPERIDONE	Direct_Rx	0b784f21-fc02-6542-e063-6294a90a285e	2025-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RISPERIDONE
risperidone	RISPERIDONE	Zydus Lifesciences Limited	23993d21-80bf-41c4-b57d-88a620173b6b	2024-08-12		Name fallback generic name: RISPERIDONE
RISPERIDONE	RISPERIDONE	NuCare Pharmaceuticals,Inc.	79648a52-1364-c25b-e053-2a91aa0a8ea4	2024-06-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RISPERIDONE
RISPERIDONE	RISPERIDONE	Bryant Ranch Prepack	420cfeef-0061-43b9-9491-dbd6ad866e55	2024-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RISPERIDONE
RISPERIDONE	RISPERIDONE	Bryant Ranch Prepack	aab773b2-a605-4cf8-a301-57e390fe67a6	2024-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RISPERIDONE
RISPERIDONE	RISPERIDONE	Bryant Ranch Prepack	2f83d3e9-04ab-4b24-ad1f-7ed2e784298a	2024-05-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RISPERIDONE
RISPERIDONE	RISPERIDONE	Bryant Ranch Prepack	e35be034-6275-41fb-bec4-9ae451458701	2024-04-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RISPERIDONE
Risperidone	RISPERIDONE	Chartwell RX, LLC	12a479c4-a84a-4308-b89f-be0315826fd5	2024-04-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RISPERIDONE
RISPERIDONE	RISPERIDONE	A-S Medication Solutions	523d4f99-1d6f-413f-9d6e-2ca430aaac14	2024-01-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RISPERIDONE
Risperidone	RISPERIDONE	Natco Pharma USA LLC	856d65dc-f330-4195-b271-d0bdbe99519d	2023-11-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: RISPERIDONE

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 · 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