Application 208643

Type: ANDA
Sponsor: LUPIN LTD

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 44.

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
A208643-001	PALIPERIDONE	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	2022-06-29
A208643-002	PALIPERIDONE	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	2022-06-29
A208643-003	PALIPERIDONE	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	2022-06-29
A208643-004	PALIPERIDONE	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	2022-06-29

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 2 of 4 · 124 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208643-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	BX	2022-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208643-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	BX	2022-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208643-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	BX	2022-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208643-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	BX	2022-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208643-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	BX	2022-06-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208643-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	BX	2022-06-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208643-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	BX	2022-06-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208643-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	BX	2022-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208643-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	BX	2022-06-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208643-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	BX	2022-06-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208643-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	BX	2022-06-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208643-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	BX	2022-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208643-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	BX	2022-06-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208643-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	BX	2022-06-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208643-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	BX	2022-06-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208643-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	BX	2022-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208643-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	BX	2022-06-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208643-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	BX	2022-06-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208643-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	BX	2022-06-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208643-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	BX	2022-06-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208643-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-06-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208643-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-06-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208643-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-06-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208643-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-06-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208643-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-06-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208643-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-06-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208643-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-06-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208643-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-06-29	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208643-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-06-29	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208643-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-06-29	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208643-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-06-29	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208643-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-06-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208643-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-06-29	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A208643-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-06-29	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A208643-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-06-29	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A208643-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-06-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208643-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-06-29	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A208643-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-06-29	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A208643-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-06-29	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A208643-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-06-29	`ea1830bbd6c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 100 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A208643-001	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208643-002	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208643-003	BX	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208643-004	BX	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208643-001	BX	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208643-002	BX	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208643-003	BX	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208643-004	BX	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208643-001	BX	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208643-002	BX	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208643-003	BX	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208643-004	BX	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208643-001	BX	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208643-002	BX	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208643-003	BX	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208643-004	BX	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208643-001	BX	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208643-002	BX	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208643-003	BX	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208643-004	BX	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208643-001	BX	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208643-002	BX	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208643-003	BX	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208643-004	BX	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208643-001	BX	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208643-002	BX	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208643-003	BX	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208643-004	BX	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208643-001	BX	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208643-002	BX	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208643-003	BX	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208643-004	BX	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208643-001	BX	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208643-002	BX	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208643-003	BX	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208643-004	BX	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208643-001	BX	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208643-002	BX	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208643-003	BX	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208643-004	BX	1	`301d65b070ca…`

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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PALIPERIDONE	PALIPERIDONE	ANI Pharmaceuticals, Inc.	bbbaa057-f587-4eb9-a0d2-463dbcd57661	2026-07-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PALIPERIDONE generic name: PALIPERIDONE
Paliperidone	PALIPERIDONE	Bryant Ranch Prepack	ff5ef11c-5c22-4a8e-89dd-4740f0ebf634	2026-05-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Paliperidone generic name: PALIPERIDONE
Paliperidone	PALIPERIDONE	Bryant Ranch Prepack	f75e884e-1883-45d7-ac9b-4a6c63f2185e	2026-05-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Paliperidone generic name: PALIPERIDONE
Paliperidone	PALIPERIDONE	Bryant Ranch Prepack	f0c13f91-0232-48b0-aa13-121805b8da13	2026-05-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Paliperidone generic name: PALIPERIDONE
Paliperidone	PALIPERIDONE	Bryant Ranch Prepack	c7472b50-fa6c-4127-a4b3-3645436274ee	2026-05-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Paliperidone generic name: PALIPERIDONE
Paliperidone	PALIPERIDONE	Westminster Pharmaceuticals, LLC	1745a460-5e3a-4a1f-8eb3-64bb112f47a4	2026-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Paliperidone generic name: PALIPERIDONE
Paliperidone	PALIPERIDONE	Major Pharmaceuticals	528a962a-4924-4c48-93ce-6ab1f019e52c	2026-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Paliperidone generic name: PALIPERIDONE
PALIPERIDONE	PALIPERIDONE	Camber Pharmaceuticals, Inc	1cfcad42-da71-457d-b1e1-aee806642d0c	2026-04-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PALIPERIDONE generic name: PALIPERIDONE
Paliperidone	PALIPERIDONE	Sun Pharmaceutical Industries, Inc.	0dc3a9b2-2edf-4fa2-a949-459b4218e763	2026-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Paliperidone generic name: PALIPERIDONE
Paliperidone	PALIPERIDONE	NorthStar RxLLC	5589ec69-c49c-44a7-9561-bbffeb918d1f	2026-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Paliperidone generic name: PALIPERIDONE
Paliperidone	PALIPERIDONE	Ajanta Pharma USA Inc.	71985eb4-07df-41c9-8b9a-85f39e92b7d0	2026-03-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Paliperidone generic name: PALIPERIDONE
Paliperidone	PALIPERIDONE	AvKARE	018cf3ca-bee9-23a6-e063-6394a90ad905	2026-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Paliperidone generic name: PALIPERIDONE
Paliperidone	PALIPERIDONE	Archis Pharma LLC	e713556e-028e-0f4c-e053-2995a90a9e9f	2025-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Paliperidone generic name: PALIPERIDONE
Paliperidone	PALIPERIDONE	Coupler LLC	463db841-297f-7692-e063-6394a90a8c14	2025-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Paliperidone generic name: PALIPERIDONE
Paliperidone	PALIPERIDONE	American Health Packaging	c6d80cc0-596e-49b9-8216-34e7b01e2df2	2025-10-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Paliperidone generic name: PALIPERIDONE
Paliperidone	PALIPERIDONE	REMEDYREPACK INC.	a5492459-e0a2-4c16-9fff-c886e0b4c700	2025-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Paliperidone generic name: PALIPERIDONE
Paliperidone	PALIPERIDONE	REMEDYREPACK INC.	85cdf6fb-d59f-4231-bd21-c8435df5930d	2025-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Paliperidone generic name: PALIPERIDONE
Paliperidone	PALIPERIDONE	REMEDYREPACK INC.	f13d3678-a861-42ba-be44-0d89f1b66ef3	2025-09-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Paliperidone generic name: PALIPERIDONE
PALIPERIDONE	PALIPERIDONE	Eskayef Pharmaceuticals Limited	de95e29f-a030-4777-a601-874500ab8e91	2025-09-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: PALIPERIDONE generic name: PALIPERIDONE
Paliperidone	PALIPERIDONE	Amneal Pharmaceuticals LLC	7b269778-803b-4ce2-a8c0-636fb131d16a	2025-09-05	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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68180-523	Paliperidone	Paliperidone	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-523	Paliperidone	Paliperidone	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-524	Paliperidone	Paliperidone	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-524	Paliperidone	Paliperidone	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-525	Paliperidone	Paliperidone	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-525	Paliperidone	Paliperidone	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-526	Paliperidone	Paliperidone	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-526	Paliperidone	Paliperidone	Lupin Pharmaceuticals, Inc.	ANDA	Current