Application 205618

Type: ANDA
Sponsor: SUN PHARM

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 42.

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	Approval date
A205618-001	PALIPERIDONE	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06
A205618-002	PALIPERIDONE	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06
A205618-003	PALIPERIDONE	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06
A205618-004	PALIPERIDONE	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205618-001	AB
A205618-002	AB
A205618-003	AB
A205618-004	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 · 168 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
2026-08-18 06:07:40	2026-07	A205618-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205618-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205618-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205618-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205618-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205618-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205618-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205618-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205618-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205618-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205618-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205618-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205618-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205618-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205618-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205618-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205618-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205618-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205618-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205618-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205618-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205618-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205618-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205618-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205618-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205618-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205618-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205618-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205618-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205618-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205618-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205618-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205618-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205618-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205618-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205618-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205618-001	PALIPERIDONE	1.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205618-002	PALIPERIDONE	3MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205618-003	PALIPERIDONE	6MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205618-004	PALIPERIDONE	9MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-04-06	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A205618-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205618-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205618-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205618-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205618-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205618-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205618-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205618-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205618-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205618-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205618-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205618-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205618-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205618-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205618-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205618-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205618-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205618-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205618-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205618-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205618-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205618-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205618-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205618-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205618-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205618-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205618-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205618-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205618-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205618-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205618-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205618-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205618-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205618-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205618-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205618-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205618-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205618-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205618-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205618-004	AB	1	`d8e5a09893c0…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Paliperidone	PALIPERIDONE	Major Pharmaceuticals	528a962a-4924-4c48-93ce-6ab1f019e52c	2026-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205618 application number: ANDA205618 ndc (product): 0904-6937 ndc (product): 0904-6936 ndc (product): 0904-6935
Paliperidone	PALIPERIDONE	Sun Pharmaceutical Industries, Inc.	0dc3a9b2-2edf-4fa2-a949-459b4218e763	2026-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205618 application number: ANDA205618 ndc (product): 47335-766 ndc (product): 47335-767 ndc (product): 47335-744 ndc (product): 47335-765
Paliperidone	PALIPERIDONE	NorthStar RxLLC	5589ec69-c49c-44a7-9561-bbffeb918d1f	2026-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205618 application number: ANDA205618 ndc (product): 16714-868 ndc (product): 16714-866 ndc (product): 16714-867 ndc (product): 16714-869
Paliperidone	PALIPERIDONE	American Health Packaging	c6d80cc0-596e-49b9-8216-34e7b01e2df2	2025-10-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205618 application number: ANDA205618 ndc (product): 60687-470 ndc (product): 60687-459
Paliperidone	PALIPERIDONE	REMEDYREPACK INC.	a5492459-e0a2-4c16-9fff-c886e0b4c700	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205618 application number: ANDA205618
Paliperidone	PALIPERIDONE	REMEDYREPACK INC.	85cdf6fb-d59f-4231-bd21-c8435df5930d	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205618 application number: ANDA205618
Paliperidone	PALIPERIDONE	REMEDYREPACK INC.	f13d3678-a861-42ba-be44-0d89f1b66ef3	2025-09-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205618 application number: ANDA205618

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6935	Paliperidone	Paliperidone	Major Pharmaceuticals	ANDA	Current
0904-6935	Paliperidone	Paliperidone	Major Pharmaceuticals	ANDA	Current
0904-6935	Paliperidone	Paliperidone	Major Pharmaceuticals	ANDA	Current
0904-6936	Paliperidone	Paliperidone	Major Pharmaceuticals	ANDA	Current
0904-6936	Paliperidone	Paliperidone	Major Pharmaceuticals	ANDA	Current
0904-6936	Paliperidone	Paliperidone	Major Pharmaceuticals	ANDA	Current
0904-6937	Paliperidone	Paliperidone	Major Pharmaceuticals	ANDA	Current
0904-6937	Paliperidone	Paliperidone	Major Pharmaceuticals	ANDA	Current
0904-6937	Paliperidone	Paliperidone	Major Pharmaceuticals	ANDA	Current
16714-866	Paliperidone	Paliperidone	NorthStar RxLLC	ANDA	Current
16714-866	Paliperidone	Paliperidone	NorthStar RxLLC	ANDA	Current
16714-867	Paliperidone	Paliperidone	NorthStar RxLLC	ANDA	Current
16714-867	Paliperidone	Paliperidone	NorthStar RxLLC	ANDA	Current
16714-868	Paliperidone	Paliperidone	NorthStar RxLLC	ANDA	Current
16714-868	Paliperidone	Paliperidone	NorthStar RxLLC	ANDA	Current
16714-869	Paliperidone	Paliperidone	NorthStar RxLLC	ANDA	Current
16714-869	Paliperidone	Paliperidone	NorthStar RxLLC	ANDA	Current
47335-744	Paliperidone	Paliperidone	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-744	Paliperidone	Paliperidone	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-765	Paliperidone	Paliperidone	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-765	Paliperidone	Paliperidone	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-766	Paliperidone	Paliperidone	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-766	Paliperidone	Paliperidone	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-767	Paliperidone	Paliperidone	Sun Pharmaceutical Industries, Inc.	ANDA	Current
47335-767	Paliperidone	Paliperidone	Sun Pharmaceutical Industries, Inc.	ANDA	Current
60687-459	Paliperidone	Paliperidone	American Health Packaging	ANDA	Current
60687-459	Paliperidone	Paliperidone	American Health Packaging	ANDA	Current
60687-470	Paliperidone	Paliperidone	American Health Packaging	ANDA	Current
60687-470	Paliperidone	Paliperidone	American Health Packaging	ANDA	Current