Application 202645

Type: ANDA
Sponsor: ACTAVIS LABS FL INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PALIPERIDONE	PALIPERIDONE	TABLET, EXTENDED RELEASE;ORAL	1.5MG	No	No
002	PALIPERIDONE	PALIPERIDONE	TABLET, EXTENDED RELEASE;ORAL	3MG	No	No
003	PALIPERIDONE	PALIPERIDONE	TABLET, EXTENDED RELEASE;ORAL	6MG	No	No
004	PALIPERIDONE	PALIPERIDONE	TABLET, EXTENDED RELEASE;ORAL	9MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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	Approval date
A202645-001	PALIPERIDONE	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	2015-08-03
A202645-002	PALIPERIDONE	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	2015-08-03
A202645-003	PALIPERIDONE	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	2015-08-03
A202645-004	PALIPERIDONE	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	2015-08-03

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 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A202645-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	2015-08-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202645-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	2015-08-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202645-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	2015-08-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202645-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	2015-08-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A202645-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	2015-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202645-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	2015-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202645-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	2015-08-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202645-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	2015-08-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202645-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	2015-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202645-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	2015-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202645-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	2015-08-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202645-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	2015-08-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202645-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	2015-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202645-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	2015-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202645-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	2015-08-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202645-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	2015-08-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202645-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	2015-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202645-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	2015-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202645-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	2015-08-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202645-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	2015-08-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202645-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	2015-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202645-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	2015-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202645-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	2015-08-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202645-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	2015-08-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202645-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	2015-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202645-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	2015-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202645-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	2015-08-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202645-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	2015-08-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202645-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	2015-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202645-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	2015-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202645-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	2015-08-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202645-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	2015-08-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202645-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	2015-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202645-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	2015-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202645-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	2015-08-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202645-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	2015-08-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202645-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	2015-08-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202645-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	2015-08-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202645-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	2015-08-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202645-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	2015-08-03	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 116 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202645-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202645-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202645-003	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202645-004	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202645-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202645-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202645-003	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202645-004	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202645-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202645-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202645-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202645-004	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202645-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202645-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202645-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202645-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202645-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202645-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202645-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202645-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202645-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202645-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202645-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202645-004	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202645-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202645-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202645-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202645-004	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202645-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202645-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202645-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202645-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202645-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202645-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202645-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202645-004	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202645-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202645-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202645-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202645-004	AB	1	`87673890dc5c…`

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 2 of 2 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Paliperidone	PALIPERIDONE	Coupler LLC	313538c9-01d3-1558-e063-6394a90aa21d	2025-03-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Paliperidone generic name: PALIPERIDONE
paliperidone	PALIPERIDONE	Alembic Pharmaceuticals Inc.	45fc28d1-132f-413b-a407-dc90e1229ee2	2025-02-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: paliperidone generic name: PALIPERIDONE
INVEGA	PALIPERIDONE	Janssen Pharmaceuticals, Inc.	7b8e5b26-b9e4-4704-921b-3c3c0d159916	2025-01-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: PALIPERIDONE
paliperidone	PALIPERIDONE	Alembic Pharmaceuticals Limited	be30f3cc-55fb-4a74-9778-60573a7f18c6	2024-09-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: paliperidone generic name: PALIPERIDONE
Paliperidone	PALIPERIDONE	Tris Pharma Inc	d7033e52-3df2-48e2-adda-15a57c2f148f	2024-07-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Paliperidone generic name: PALIPERIDONE

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 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-3692	Paliperidone	Paliperidone	Actavis Pharma, Inc.	ANDA	Current
0591-3692	Paliperidone	Paliperidone	Actavis Pharma, Inc.	ANDA	Current
0591-3692	Paliperidone	Paliperidone	Actavis Pharma, Inc.	ANDA	Current
0591-3692	Paliperidone	Paliperidone	Actavis Pharma, Inc.	ANDA	Current
0591-3693	Paliperidone	Paliperidone	Actavis Pharma, Inc.	ANDA	Current
0591-3693	Paliperidone	Paliperidone	Actavis Pharma, Inc.	ANDA	Current
0591-3693	Paliperidone	Paliperidone	Actavis Pharma, Inc.	ANDA	Current
0591-3693	Paliperidone	Paliperidone	Actavis Pharma, Inc.	ANDA	Current
0591-3694	Paliperidone	Paliperidone	Actavis Pharma, Inc.	ANDA	Current
0591-3694	Paliperidone	Paliperidone	Actavis Pharma, Inc.	ANDA	Current
0591-3694	Paliperidone	Paliperidone	Actavis Pharma, Inc.	ANDA	Current
0591-3694	Paliperidone	Paliperidone	Actavis Pharma, Inc.	ANDA	Current
0591-3695	Paliperidone	Paliperidone	Actavis Pharma, Inc.	ANDA	Current
0591-3695	Paliperidone	Paliperidone	Actavis Pharma, Inc.	ANDA	Current
0591-3695	Paliperidone	Paliperidone	Actavis Pharma, Inc.	ANDA	Current
0591-3695	Paliperidone	Paliperidone	Actavis Pharma, Inc.	ANDA	Current
68151-5041	Paliperidone	Paliperidone	Carilion Materials Management	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
10089	ORIG	2015-08-06