Application 021999

Type: NDA
Sponsor: JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	INVEGA	PALIPERIDONE	TABLET, EXTENDED RELEASE;ORAL	3MG	Yes	No
002	INVEGA	PALIPERIDONE	TABLET, EXTENDED RELEASE;ORAL	6MG	Yes	Yes
003	INVEGA	PALIPERIDONE	TABLET, EXTENDED RELEASE;ORAL	9MG	Yes	No
004	INVEGA	PALIPERIDONE	TABLET, EXTENDED RELEASE;ORAL	12MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
006	INVEGA	PALIPERIDONE	TABLET, EXTENDED RELEASE;ORAL	1.5MG	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	TE codes	RLD / RS	Approval date
N021999-001	INVEGA	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2006-12-19
N021999-002	INVEGA	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2006-12-19
N021999-003	INVEGA	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2006-12-19
N021999-004	INVEGA	PALIPERIDONE	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2006-12-19
N021999-006	INVEGA	PALIPERIDONE	1.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-08-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N021999-001	AB
N021999-002	AB
N021999-003	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 6 · 205 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	N021999-001	INVEGA	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2006-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021999-002	INVEGA	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2006-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021999-003	INVEGA	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2006-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021999-004	INVEGA	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2006-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021999-006	INVEGA	1.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-08-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021999-001	INVEGA	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2006-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021999-002	INVEGA	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2006-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021999-003	INVEGA	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2006-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021999-004	INVEGA	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2006-12-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021999-006	INVEGA	1.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-08-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021999-001	INVEGA	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2006-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021999-002	INVEGA	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2006-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021999-003	INVEGA	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2006-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021999-004	INVEGA	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2006-12-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021999-006	INVEGA	1.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-08-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021999-001	INVEGA	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2006-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021999-002	INVEGA	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2006-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021999-003	INVEGA	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2006-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021999-004	INVEGA	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2006-12-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021999-006	INVEGA	1.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-08-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021999-001	INVEGA	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2006-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021999-002	INVEGA	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2006-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021999-003	INVEGA	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2006-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021999-004	INVEGA	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2006-12-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021999-006	INVEGA	1.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-08-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021999-001	INVEGA	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2006-12-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021999-002	INVEGA	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2006-12-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021999-003	INVEGA	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2006-12-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021999-004	INVEGA	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2006-12-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021999-006	INVEGA	1.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-08-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021999-001	INVEGA	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2006-12-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021999-002	INVEGA	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2006-12-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021999-003	INVEGA	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2006-12-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021999-004	INVEGA	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2006-12-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021999-006	INVEGA	1.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-08-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021999-001	INVEGA	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2006-12-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021999-002	INVEGA	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2006-12-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021999-003	INVEGA	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2006-12-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021999-004	INVEGA	12MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2006-12-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021999-006	INVEGA	1.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL		RLD	2008-08-26	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 149 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	N021999-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021999-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021999-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021999-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021999-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021999-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021999-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021999-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021999-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021999-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021999-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021999-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021999-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021999-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021999-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021999-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021999-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021999-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021999-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021999-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021999-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021999-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021999-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021999-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021999-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021999-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021999-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021999-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021999-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021999-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021999-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021999-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021999-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021999-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021999-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021999-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021999-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021999-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021999-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021999-001	AB	1	`8072bd15b7f6…`

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
INVEGA	PALIPERIDONE	Janssen Pharmaceuticals, Inc.	7b8e5b26-b9e4-4704-921b-3c3c0d159916	2025-01-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021999 application number: NDA021999 ndc (product): 50458-552 ndc (product): 50458-550 ndc (product): 50458-551 ndc (product): 50458-554

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
10147-0951	Paliperidone	paliperidone	Patriot Pharmaceuticals, LLC	NDA	Current
10147-0951	Paliperidone	paliperidone	Patriot Pharmaceuticals, LLC	NDA	Current
10147-0951	Paliperidone	paliperidone	Patriot Pharmaceuticals, LLC	NDA	Current
10147-0951	Paliperidone	paliperidone	Patriot Pharmaceuticals, LLC	NDA	Current
10147-0951	Paliperidone	paliperidone	Patriot Pharmaceuticals, LLC	NDA	Current
10147-0952	Paliperidone	paliperidone	Patriot Pharmaceuticals, LLC	NDA	Current
10147-0952	Paliperidone	paliperidone	Patriot Pharmaceuticals, LLC	NDA	Current
10147-0952	Paliperidone	paliperidone	Patriot Pharmaceuticals, LLC	NDA	Current
10147-0952	Paliperidone	paliperidone	Patriot Pharmaceuticals, LLC	NDA	Current
10147-0952	Paliperidone	paliperidone	Patriot Pharmaceuticals, LLC	NDA	Current
10147-0953	Paliperidone	paliperidone	Patriot Pharmaceuticals, LLC	NDA	Current
10147-0953	Paliperidone	paliperidone	Patriot Pharmaceuticals, LLC	NDA	Current
10147-0953	Paliperidone	paliperidone	Patriot Pharmaceuticals, LLC	NDA	Current
10147-0953	Paliperidone	paliperidone	Patriot Pharmaceuticals, LLC	NDA	Current
10147-0953	Paliperidone	paliperidone	Patriot Pharmaceuticals, LLC	NDA	Current
10147-0954	Paliperidone	paliperidone	Patriot Pharmaceuticals, LLC	NDA	Current
10147-0954	Paliperidone	paliperidone	Patriot Pharmaceuticals, LLC	NDA	Current
10147-0954	Paliperidone	paliperidone	Patriot Pharmaceuticals, LLC	NDA	Current
10147-0954	Paliperidone	paliperidone	Patriot Pharmaceuticals, LLC	NDA	Current
10147-0954	Paliperidone	paliperidone	Patriot Pharmaceuticals, LLC	NDA	Current
21695-455	INVEGA	paliperidone	Rebel Distributors Corp	NDA	Current
50458-550	INVEGA	paliperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-550	INVEGA	paliperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-550	INVEGA	paliperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-550	INVEGA	paliperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-550	INVEGA	paliperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-550	INVEGA	paliperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-550	INVEGA	paliperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-550	INVEGA	paliperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-551	INVEGA	paliperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-551	INVEGA	paliperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-551	INVEGA	paliperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-551	INVEGA	paliperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-551	INVEGA	paliperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-551	INVEGA	paliperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-551	INVEGA	paliperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-551	INVEGA	paliperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-552	INVEGA	paliperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-552	INVEGA	paliperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-552	INVEGA	paliperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-552	INVEGA	paliperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-552	INVEGA	paliperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-552	INVEGA	paliperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-552	INVEGA	paliperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-552	INVEGA	paliperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-554	INVEGA	paliperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-554	INVEGA	paliperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-554	INVEGA	paliperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-554	INVEGA	paliperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-554	INVEGA	paliperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-554	INVEGA	paliperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-554	INVEGA	paliperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-554	INVEGA	paliperidone	Janssen Pharmaceuticals, Inc.	NDA	Current
64725-0550	INVEGA	paliperidone	TYA Pharmaceuticals	NDA	Current
70518-0850	Paliperidone	paliperidone	REMEDYREPACK INC.	NDA	Current
70518-0850	Paliperidone	paliperidone	REMEDYREPACK INC.	NDA	Current
70518-2034	Paliperidone	paliperidone	REMEDYREPACK INC.	NDA	Current
70518-2197	Paliperidone	paliperidone	REMEDYREPACK INC.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80905	SUPPL	2025-03-12
80903	SUPPL	2025-03-12
81067	SUPPL	2025-02-06
81066	SUPPL	2025-02-06
70747	SUPPL	2022-04-11
66265	SUPPL	2021-02-17
66261	SUPPL	2021-02-17
57562	SUPPL	2019-02-13
57364	SUPPL	2019-01-28
55562	SUPPL	2018-09-21
55054	SUPPL	2018-07-30
49484	SUPPL	2017-08-21
49462	SUPPL	2017-08-18
47407	SUPPL	2017-03-02
47315	SUPPL	2017-02-24
29035	SUPPL	2016-03-03
16733	SUPPL	2016-03-03
42380	SUPPL	2014-08-05
38057	SUPPL	2014-05-02
29034	SUPPL	2014-05-01
23688	ORIG	2011-12-22
29032	SUPPL	2011-04-11
6652	SUPPL	2011-04-11
38056	SUPPL	2011-04-07
16732	SUPPL	2011-04-07
16729	SUPPL	2011-02-24
6651	SUPPL	2011-02-18
29033	SUPPL	2010-12-07
16731	SUPPL	2010-12-04
29031	SUPPL	2010-03-11
16730	SUPPL	2010-03-05
16726	SUPPL	2009-11-04
29030	SUPPL	2009-08-06
6649	SUPPL	2009-08-06
38055	SUPPL	2009-08-04
16727	SUPPL	2009-08-04
16728	SUPPL	2009-07-23
6650	SUPPL	2009-07-23
38052	SUPPL	2008-09-05
6647	SUPPL	2008-09-05
38053	SUPPL	2008-08-29
38051	SUPPL	2008-08-29
29029	SUPPL	2008-08-28
29027	SUPPL	2008-08-28
38054	SUPPL	2008-08-26
6648	SUPPL	2008-08-19
29028	SUPPL	2008-05-21
29026	SUPPL	2008-01-09
6646	SUPPL	2008-01-09
38050	SUPPL	2008-01-08
42379	ORIG	2007-03-30
38049	ORIG	2006-12-28
29025	ORIG	2006-12-28
64033	ORIG	1900-01-01
64032	ORIG	1900-01-01
64031	ORIG	1900-01-01
53364	ORIG	1900-01-01
53363	ORIG	1900-01-01
53362	ORIG	1900-01-01