Application 021346

Type: NDA
Sponsor: JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RISPERDAL CONSTA	RISPERIDONE	INJECTABLE;INTRAMUSCULAR	25MG/VIAL	Yes	Yes
002	RISPERDAL CONSTA	RISPERIDONE	INJECTABLE;INTRAMUSCULAR	37.5MG/VIAL	Yes	No
003	RISPERDAL CONSTA	RISPERIDONE	INJECTABLE;INTRAMUSCULAR	50MG/VIAL	Yes	No
004	RISPERDAL CONSTA	RISPERIDONE	INJECTABLE;INTRAMUSCULAR	12.5MG/VIAL	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021346-001	RISPERDAL CONSTA	RISPERIDONE	25MG/VIAL	POWDER / INTRAMUSCULAR	AB	RLD, RS	2003-10-29
N021346-002	RISPERDAL CONSTA	RISPERIDONE	37.5MG/VIAL	POWDER / INTRAMUSCULAR	AB	RLD, RS	2003-10-29
N021346-003	RISPERDAL CONSTA	RISPERIDONE	50MG/VIAL	POWDER / INTRAMUSCULAR	AB	RLD, RS	2003-10-29
N021346-004	RISPERDAL CONSTA	RISPERIDONE	12.5MG/VIAL	POWDER / INTRAMUSCULAR	AB	RLD, RS	2007-04-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N021346-001	AB
N021346-002	AB
N021346-003	AB
N021346-004	AB

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 5 · 164 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	N021346-001	RISPERDAL CONSTA	25MG/VIAL	POWDER / INTRAMUSCULAR	AB	RLD, RS	2003-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021346-002	RISPERDAL CONSTA	37.5MG/VIAL	POWDER / INTRAMUSCULAR	AB	RLD, RS	2003-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021346-003	RISPERDAL CONSTA	50MG/VIAL	POWDER / INTRAMUSCULAR	AB	RLD, RS	2003-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021346-004	RISPERDAL CONSTA	12.5MG/VIAL	POWDER / INTRAMUSCULAR	AB	RLD, RS	2007-04-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021346-001	RISPERDAL CONSTA	25MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	RLD, RS	2003-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021346-002	RISPERDAL CONSTA	37.5MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	RLD	2003-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021346-003	RISPERDAL CONSTA	50MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	RLD	2003-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021346-004	RISPERDAL CONSTA	12.5MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	RLD	2007-04-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021346-001	RISPERDAL CONSTA	25MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	RLD, RS	2003-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021346-002	RISPERDAL CONSTA	37.5MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	RLD	2003-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021346-003	RISPERDAL CONSTA	50MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	RLD	2003-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021346-004	RISPERDAL CONSTA	12.5MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	RLD	2007-04-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021346-001	RISPERDAL CONSTA	25MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	RLD, RS	2003-10-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021346-002	RISPERDAL CONSTA	37.5MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	RLD	2003-10-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021346-003	RISPERDAL CONSTA	50MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	RLD	2003-10-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021346-004	RISPERDAL CONSTA	12.5MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	RLD	2007-04-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021346-001	RISPERDAL CONSTA	25MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	RLD, RS	2003-10-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021346-002	RISPERDAL CONSTA	37.5MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	RLD	2003-10-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021346-003	RISPERDAL CONSTA	50MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	RLD	2003-10-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021346-004	RISPERDAL CONSTA	12.5MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	RLD	2007-04-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021346-001	RISPERDAL CONSTA	25MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	RLD, RS	2003-10-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021346-002	RISPERDAL CONSTA	37.5MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	RLD	2003-10-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021346-003	RISPERDAL CONSTA	50MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	RLD	2003-10-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021346-004	RISPERDAL CONSTA	12.5MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	RLD	2007-04-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021346-001	RISPERDAL CONSTA	25MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	RLD, RS	2003-10-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021346-002	RISPERDAL CONSTA	37.5MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	RLD	2003-10-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021346-003	RISPERDAL CONSTA	50MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	RLD	2003-10-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021346-004	RISPERDAL CONSTA	12.5MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	RLD	2007-04-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021346-001	RISPERDAL CONSTA	25MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	RLD, RS	2003-10-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021346-002	RISPERDAL CONSTA	37.5MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	RLD	2003-10-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021346-003	RISPERDAL CONSTA	50MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	RLD	2003-10-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021346-004	RISPERDAL CONSTA	12.5MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	RLD	2007-04-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021346-001	RISPERDAL CONSTA	25MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	RLD, RS	2003-10-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021346-002	RISPERDAL CONSTA	37.5MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	RLD	2003-10-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021346-003	RISPERDAL CONSTA	50MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	RLD	2003-10-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021346-004	RISPERDAL CONSTA	12.5MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	RLD	2007-04-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021346-001	RISPERDAL CONSTA	25MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	RLD, RS	2003-10-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021346-002	RISPERDAL CONSTA	37.5MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	RLD	2003-10-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021346-003	RISPERDAL CONSTA	50MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	RLD	2003-10-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021346-004	RISPERDAL CONSTA	12.5MG/VIAL	INJECTABLE / INTRAMUSCULAR	AB	RLD	2007-04-12	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 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	N021346-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021346-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021346-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021346-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021346-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021346-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021346-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021346-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021346-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021346-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021346-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021346-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021346-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021346-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021346-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021346-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021346-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021346-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021346-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021346-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021346-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021346-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021346-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021346-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021346-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021346-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021346-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021346-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021346-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021346-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021346-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021346-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021346-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021346-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021346-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021346-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021346-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021346-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021346-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021346-004	AB	1	`d06236e962d9…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021346-001	6194006*PED	2019-06-30	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021346-001	6379703*PED	2019-06-30	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021346-001	6596316*PED	2019-06-30	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021346-001	6667061	2020-05-25	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021346-001	6667061*PED	2020-11-25	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021346-002	6194006*PED	2019-06-30	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021346-002	6379703*PED	2019-06-30	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021346-002	6596316*PED	2019-06-30	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021346-002	6667061	2020-05-25	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021346-002	6667061*PED	2020-11-25	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021346-003	6194006*PED	2019-06-30	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021346-003	6379703*PED	2019-06-30	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021346-003	6596316*PED	2019-06-30	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021346-003	6667061	2020-05-25	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021346-003	6667061*PED	2020-11-25	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021346-004	6194006*PED	2019-06-30	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021346-004	6379703*PED	2019-06-30	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021346-004	6596316*PED	2019-06-30	Pediatric extension	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N021346-001	6667061	2020-05-25	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021346-001	6667061*PED	2020-11-25	Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021346-002	6667061	2020-05-25	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021346-002	6667061*PED	2020-11-25	Pediatric extension	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021346-003	6667061	2020-05-25	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021346-003	6667061*PED	2020-11-25	Pediatric extension	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021346-001	6667061	2020-05-25	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021346-001	6667061*PED	2020-11-25	Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021346-002	6667061	2020-05-25	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021346-002	6667061*PED	2020-11-25	Pediatric extension	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021346-003	6667061	2020-05-25	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021346-003	6667061*PED	2020-11-25	Pediatric extension	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021346-001	6194006*PED	2019-06-30	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021346-001	6379703*PED	2019-06-30	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021346-001	6596316*PED	2019-06-30	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021346-001	6667061	2020-05-25	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021346-001	6667061*PED	2020-11-25	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021346-002	6194006*PED	2019-06-30	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021346-002	6379703*PED	2019-06-30	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021346-002	6596316*PED	2019-06-30	Pediatric extension	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021346-002	6667061	2020-05-25	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021346-002	6667061*PED	2020-11-25	Pediatric extension	`3f01610625f2…`

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
RISPERDAL CONSTA	RISPERIDONE	Janssen Pharmaceuticals, Inc.	bb34ee82-d2c2-43b8-ba21-2825c0954691	2025-11-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021346 application number: NDA021346 ndc (product): 50458-306 ndc (product): 50458-308 ndc (product): 50458-307 ndc (product): 50458-309

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50458-306	RISPERDAL CONSTA	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-306	RISPERDAL CONSTA	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-306	RISPERDAL CONSTA	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-306	RISPERDAL CONSTA	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-306	RISPERDAL CONSTA	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-307	RISPERDAL CONSTA	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-307	RISPERDAL CONSTA	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-307	RISPERDAL CONSTA	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-307	RISPERDAL CONSTA	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-307	RISPERDAL CONSTA	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-308	RISPERDAL CONSTA	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-308	RISPERDAL CONSTA	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-308	RISPERDAL CONSTA	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-308	RISPERDAL CONSTA	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-308	RISPERDAL CONSTA	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-309	RISPERDAL CONSTA	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-309	RISPERDAL CONSTA	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-309	RISPERDAL CONSTA	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-309	RISPERDAL CONSTA	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-309	RISPERDAL CONSTA	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83889	SUPPL	2025-10-23
81128	SUPPL	2025-02-07
81029	SUPPL	2025-02-05
71934	SUPPL	2022-08-26
71933	SUPPL	2022-08-26
71921	SUPPL	2022-08-26
71919	SUPPL	2022-08-26
71917	SUPPL	2022-08-26
71916	SUPPL	2022-08-26
71914	SUPPL	2022-08-26
71912	SUPPL	2022-08-26
71910	SUPPL	2022-08-26
71909	SUPPL	2022-08-26
71907	SUPPL	2022-08-26
71905	SUPPL	2022-08-26
71902	SUPPL	2022-08-26
71897	SUPPL	2022-08-26
71895	SUPPL	2022-08-26
66280	SUPPL	2021-02-18
66242	SUPPL	2021-02-17
65868	SUPPL	2021-01-08
61843	SUPPL	2020-02-07
61788	SUPPL	2020-02-06
57556	SUPPL	2019-02-13
57363	SUPPL	2019-01-28
55147	SUPPL	2018-08-09
55053	SUPPL	2018-07-30
47423	SUPPL	2017-03-02
47321	SUPPL	2017-02-24
36722	SUPPL	2016-03-03
27558	SUPPL	2016-03-03
36721	SUPPL	2014-06-10
27557	SUPPL	2014-05-09
15253	SUPPL	2014-04-29
27556	SUPPL	2012-03-13
23648	ORIG	2011-12-20
27555	SUPPL	2011-12-13
15250	SUPPL	2011-12-13
15246	SUPPL	2011-12-13
5116	SUPPL	2011-12-13
36719	SUPPL	2011-09-30
15252	SUPPL	2011-09-30
27552	SUPPL	2011-09-28
5121	SUPPL	2011-09-28
36718	SUPPL	2011-09-02
27551	SUPPL	2011-08-26
5120	SUPPL	2011-06-17
15251	SUPPL	2011-06-16
5119	SUPPL	2010-12-06
15249	SUPPL	2010-12-04
27554	SUPPL	2010-09-01
27553	SUPPL	2010-09-01
27550	SUPPL	2010-09-01
5118	SUPPL	2010-09-01
36720	SUPPL	2010-08-30
36717	SUPPL	2010-08-30
15248	SUPPL	2010-08-30
15245	SUPPL	2010-08-30
15247	SUPPL	2009-08-06
5117	SUPPL	2009-08-06
36716	SUPPL	2009-06-07
36714	SUPPL	2009-06-07
5115	SUPPL	2009-05-20
5113	SUPPL	2009-05-20
36715	SUPPL	2008-11-07
36713	SUPPL	2008-11-07
36712	SUPPL	2008-11-07
15244	SUPPL	2008-11-07
27548	SUPPL	2008-10-14
5114	SUPPL	2008-10-14
5112	SUPPL	2008-10-14
5111	SUPPL	2008-10-14
27549	SUPPL	2008-08-19
36711	SUPPL	2007-04-20
27547	SUPPL	2007-04-20
15243	SUPPL	2007-03-15
5110	SUPPL	2007-03-15
5109	SUPPL	2006-10-23
27546	SUPPL	2006-09-25
15242	SUPPL	2006-09-21
27545	SUPPL	2006-08-04
27544	SUPPL	2005-08-19
15241	SUPPL	2005-08-19
21611	ORIG	2005-06-16
27543	ORIG	2003-11-28