Application 021444

Type: NDA
Sponsor: JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RISPERDAL	RISPERIDONE	TABLET, ORALLY DISINTEGRATING;ORAL	0.5MG	Yes	No
002	RISPERDAL	RISPERIDONE	TABLET, ORALLY DISINTEGRATING;ORAL	1MG	Yes	Yes
003	RISPERDAL	RISPERIDONE	TABLET, ORALLY DISINTEGRATING;ORAL	2MG	Yes	No
004	RISPERDAL	RISPERIDONE	TABLET, ORALLY DISINTEGRATING;ORAL	3MG	Yes	No
005	RISPERDAL	RISPERIDONE	TABLET, ORALLY DISINTEGRATING;ORAL	4MG	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N021444-001	RISPERDAL	RISPERIDONE	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02
N021444-002	RISPERDAL	RISPERIDONE	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02
N021444-003	RISPERDAL	RISPERIDONE	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02
N021444-004	RISPERDAL	RISPERIDONE	3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23
N021444-005	RISPERDAL	RISPERIDONE	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23

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 6 · 205 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	N021444-001	RISPERDAL	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021444-002	RISPERDAL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021444-003	RISPERDAL	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021444-004	RISPERDAL	3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021444-005	RISPERDAL	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021444-001	RISPERDAL	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021444-002	RISPERDAL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021444-003	RISPERDAL	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021444-004	RISPERDAL	3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021444-005	RISPERDAL	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021444-001	RISPERDAL	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021444-002	RISPERDAL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021444-003	RISPERDAL	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021444-004	RISPERDAL	3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021444-005	RISPERDAL	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021444-001	RISPERDAL	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021444-002	RISPERDAL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021444-003	RISPERDAL	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021444-004	RISPERDAL	3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021444-005	RISPERDAL	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021444-001	RISPERDAL	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021444-002	RISPERDAL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021444-003	RISPERDAL	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021444-004	RISPERDAL	3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021444-005	RISPERDAL	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021444-001	RISPERDAL	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021444-002	RISPERDAL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021444-003	RISPERDAL	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021444-004	RISPERDAL	3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021444-005	RISPERDAL	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021444-001	RISPERDAL	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021444-002	RISPERDAL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021444-003	RISPERDAL	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021444-004	RISPERDAL	3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021444-005	RISPERDAL	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021444-001	RISPERDAL	0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021444-002	RISPERDAL	1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021444-003	RISPERDAL	2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2003-04-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021444-004	RISPERDAL	3MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021444-005	RISPERDAL	4MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2004-12-23	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021444-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021444-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021444-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021444-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021444-005	AB	1	`74a2ff9319b5…`
2021-03-12 10:30 UTC	2021-03	N021444-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021444-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021444-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021444-004	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021444-005	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021444-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021444-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021444-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021444-004	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021444-005	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021444-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021444-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021444-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021444-004	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021444-005	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021444-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021444-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021444-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021444-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021444-005	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021444-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021444-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021444-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021444-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021444-005	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021444-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021444-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021444-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021444-004	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021444-005	AB	1	`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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Risperidone	RISPERIDONE	Janssen Pharmaceutical, Inc.	701e1cd8-2868-4d29-85a9-a2212c88165f	2026-06-12	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (product): 50458-603 ndc (product): 50458-601 ndc (product): 50458-602
RISPERDAL	RISPERIDONE	Janssen Pharmaceuticals, Inc.	7e117c7e-02fc-4343-92a1-230061dfc5e0	2026-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021444 application number: NDA021444 ndc (product): 50458-315 ndc (product): 50458-335 ndc (product): 50458-325 ndc (product): 50458-355 ndc (product): 50458-395

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 58 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50458-315	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-315	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-315	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-315	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-315	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-315	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-315	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-315	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-315	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-315	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-315	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-325	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-325	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-325	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-325	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-325	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-325	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-325	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-325	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-325	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-325	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-325	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-335	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-335	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-335	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-335	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-335	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-335	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-335	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-335	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-335	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-335	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-335	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-355	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-355	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-355	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-355	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-355	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-355	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-355	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-355	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-355	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-355	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-355	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-395	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-395	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-395	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-395	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-395	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-395	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-395	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-395	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-395	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-395	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-395	RISPERDAL M-TAB	risperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-601	Risperidone M-TAB	risperidone	Janssen Pharmaceutical, Inc.	NDA	Current
50458-602	Risperidone M-TAB	risperidone	Janssen Pharmaceutical, Inc.	NDA	Current
50458-603	Risperidone M-TAB	risperidone	Janssen Pharmaceutical, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83892	SUPPL	2025-10-23
81129	SUPPL	2025-02-07
81033	SUPPL	2025-02-06
72792	SUPPL	2022-12-05
72784	SUPPL	2022-12-05
66283	SUPPL	2021-02-18
66241	SUPPL	2021-02-17
61845	SUPPL	2020-02-07
61787	SUPPL	2020-02-06
57555	SUPPL	2019-02-13
57362	SUPPL	2019-01-28
55146	SUPPL	2018-08-09
55052	SUPPL	2018-07-30
47422	SUPPL	2017-03-02
47318	SUPPL	2017-02-24
15486	SUPPL	2016-03-03
5398	SUPPL	2016-03-03
27806	SUPPL	2014-05-09
15485	SUPPL	2014-04-29
42171	SUPPL	2013-06-03
21660	SUPPL	2013-06-03
36946	SUPPL	2012-08-03
5395	SUPPL	2012-08-03
5397	SUPPL	2012-03-13
23661	ORIG	2011-12-20
42172	SUPPL	2011-12-14
21661	SUPPL	2011-12-14
36947	SUPPL	2011-09-30
15482	SUPPL	2011-09-30
27802	SUPPL	2011-09-28
5396	SUPPL	2011-09-28
27801	SUPPL	2011-08-26
15481	SUPPL	2011-08-25
27805	SUPPL	2011-06-17
36945	SUPPL	2011-06-16
27804	SUPPL	2010-12-06
15484	SUPPL	2010-12-04
27803	SUPPL	2010-09-07
5394	SUPPL	2010-09-07
5393	SUPPL	2010-09-07
5392	SUPPL	2010-09-07
36944	SUPPL	2010-08-30
36943	SUPPL	2010-08-30
36941	SUPPL	2010-08-30
15483	SUPPL	2010-08-30
27800	SUPPL	2009-08-06
36942	SUPPL	2009-07-21
27799	SUPPL	2008-08-19
42170	SUPPL	2008-02-19
36940	SUPPL	2007-08-23
15480	SUPPL	2007-08-23
27798	SUPPL	2007-08-22
5391	SUPPL	2007-08-22
27797	SUPPL	2006-10-18
5389	SUPPL	2006-10-18
15479	SUPPL	2006-10-11
15477	SUPPL	2006-10-11
36939	SUPPL	2005-08-19
5390	SUPPL	2005-08-19
15478	SUPPL	2004-12-29
5388	SUPPL	2004-12-29
36938	SUPPL	2003-12-11
27795	SUPPL	2003-12-11
15476	SUPPL	2003-12-11
5385	SUPPL	2003-12-11
5387	SUPPL	2003-11-28
27796	SUPPL	2003-11-25
5386	SUPPL	2003-09-25
42169	ORIG	2003-07-15
27794	ORIG	2003-05-29
36937	ORIG	2003-04-07