Application 207946

Type: NDA
Sponsor: JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	INVEGA TRINZA	PALIPERIDONE PALMITATE	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	273MG/0.875ML (273MG/0.875ML)	Yes	No
002	INVEGA TRINZA	PALIPERIDONE PALMITATE	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	410MG/1.315ML (311.79MG/ML)	Yes	No
003	INVEGA TRINZA	PALIPERIDONE PALMITATE	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	546MG/1.75ML (312MG/ML)	Yes	No
004	INVEGA TRINZA	PALIPERIDONE PALMITATE	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	819MG/2.625ML (312MG/ML)	Yes	Yes
005	INVEGA HAFYERA	PALIPERIDONE PALMITATE	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	1,092MG/3.5ML	Yes	No
006	INVEGA HAFYERA	PALIPERIDONE PALMITATE	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	1,560MG/5ML	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N207946-001	INVEGA TRINZA	PALIPERIDONE PALMITATE	273MG/0.875ML (273MG/0.875ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18
N207946-002	INVEGA TRINZA	PALIPERIDONE PALMITATE	410MG/1.315ML (311.79MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18
N207946-003	INVEGA TRINZA	PALIPERIDONE PALMITATE	546MG/1.75ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18
N207946-004	INVEGA TRINZA	PALIPERIDONE PALMITATE	819MG/2.625ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18
N207946-005	INVEGA HAFYERA	PALIPERIDONE PALMITATE	1.092GM/3.5ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-08-30
N207946-006	INVEGA HAFYERA	PALIPERIDONE PALMITATE	1.560GM/5ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-08-30

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N207946-001	10143693	2036-04-05	U-2457	2018-12-18
N207946-001	10143693	2036-04-05	U-2458	2018-12-18
N207946-002	10143693	2036-04-05	U-2457	2018-12-18
N207946-002	10143693	2036-04-05	U-2458	2018-12-18
N207946-003	10143693	2036-04-05	U-2457	2018-12-18
N207946-003	10143693	2036-04-05	U-2458	2018-12-18
N207946-004	10143693	2036-04-05	U-2457	2018-12-18
N207946-004	10143693	2036-04-05	U-2458	2018-12-18
N207946-005	11304951	2041-05-07	U-3349	2022-04-25
N207946-005	11324751	2041-05-07	U-3359	2022-05-12
N207946-005	12208100	2041-05-07	U-3359	2025-02-06
N207946-005	12208100	2041-05-07	U-4110	2025-02-06
N207946-005	11666697	2041-11-24	U-3626	2023-06-15
N207946-006	11304951	2041-05-07	U-3349	2022-04-25
N207946-006	11324751	2041-05-07	U-3359	2022-05-12
N207946-006	12208100	2041-05-07	U-3359	2025-02-06
N207946-006	12208100	2041-05-07	U-4110	2025-02-06
N207946-006	11666697	2041-11-24	U-3626	2023-06-15

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 · 230 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	N207946-001	INVEGA TRINZA	273MG/0.875ML (273MG/0.875ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207946-002	INVEGA TRINZA	410MG/1.315ML (311.79MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207946-003	INVEGA TRINZA	546MG/1.75ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207946-004	INVEGA TRINZA	819MG/2.625ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207946-005	INVEGA HAFYERA	1.092GM/3.5ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-08-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207946-006	INVEGA HAFYERA	1.560GM/5ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2021-08-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-001	INVEGA TRINZA	273MG/0.875ML (273MG/0.875ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-002	INVEGA TRINZA	410MG/1.315ML (311.79MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-003	INVEGA TRINZA	546MG/1.75ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-004	INVEGA TRINZA	819MG/2.625ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-005	INVEGA HAFYERA	1.092GM/3.5ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2021-08-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-006	INVEGA HAFYERA	1.560GM/5ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2021-08-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207946-001	INVEGA TRINZA	273MG/0.875ML (273MG/0.875ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207946-002	INVEGA TRINZA	410MG/1.315ML (311.79MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207946-003	INVEGA TRINZA	546MG/1.75ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207946-004	INVEGA TRINZA	819MG/2.625ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207946-005	INVEGA HAFYERA	1.092GM/3.5ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2021-08-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207946-006	INVEGA HAFYERA	1.560GM/5ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2021-08-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207946-001	INVEGA TRINZA	273MG/0.875ML (273MG/0.875ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207946-002	INVEGA TRINZA	410MG/1.315ML (311.79MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207946-003	INVEGA TRINZA	546MG/1.75ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207946-004	INVEGA TRINZA	819MG/2.625ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207946-005	INVEGA HAFYERA	1.092GM/3.5ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2021-08-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207946-006	INVEGA HAFYERA	1.560GM/5ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2021-08-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207946-001	INVEGA TRINZA	273MG/0.875ML (273MG/0.875ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207946-002	INVEGA TRINZA	410MG/1.315ML (311.79MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207946-003	INVEGA TRINZA	546MG/1.75ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207946-004	INVEGA TRINZA	819MG/2.625ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207946-005	INVEGA HAFYERA	1.092GM/3.5ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2021-08-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207946-006	INVEGA HAFYERA	1.560GM/5ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2021-08-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207946-001	INVEGA TRINZA	273MG/0.875ML (273MG/0.875ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207946-002	INVEGA TRINZA	410MG/1.315ML (311.79MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207946-003	INVEGA TRINZA	546MG/1.75ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207946-004	INVEGA TRINZA	819MG/2.625ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207946-005	INVEGA HAFYERA	1.092GM/3.5ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2021-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207946-006	INVEGA HAFYERA	1.560GM/5ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2021-08-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207946-001	INVEGA TRINZA	273MG/0.875ML (273MG/0.875ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207946-002	INVEGA TRINZA	410MG/1.315ML (311.79MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207946-003	INVEGA TRINZA	546MG/1.75ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207946-004	INVEGA TRINZA	819MG/2.625ML (312MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-05-18	`2680178bc6a6…`

Observed Orange Book patent history#

Patent history page 1 of 13 · 510 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N207946-001	10143693	2036-04-05	U-2458	2018-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207946-001	10143693	2036-04-05	U-2457	2018-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207946-002	10143693	2036-04-05	U-2457	2018-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207946-002	10143693	2036-04-05	U-2458	2018-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207946-003	10143693	2036-04-05	U-2458	2018-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207946-003	10143693	2036-04-05	U-2457	2018-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207946-004	10143693	2036-04-05	U-2458	2018-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207946-004	10143693	2036-04-05	U-2457	2018-12-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207946-005	11304951	2041-05-07	U-3349	2022-04-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207946-005	11324751	2041-05-07	U-3359	2022-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207946-005	12208100	2041-05-07	U-3359	2025-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207946-005	12208100	2041-05-07	U-4110	2025-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207946-005	11666697	2041-11-24	U-3626	2023-06-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207946-006	11304951	2041-05-07	U-3349	2022-04-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207946-006	11324751	2041-05-07	U-3359	2022-05-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207946-006	12208100	2041-05-07	U-4110	2025-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207946-006	12208100	2041-05-07	U-3359	2025-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207946-006	11666697	2041-11-24	U-3626	2023-06-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-001	10143693	2036-04-05	U-2458	2018-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-001	10143693	2036-04-05	U-2457	2018-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-002	10143693	2036-04-05	U-2457	2018-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-002	10143693	2036-04-05	U-2458	2018-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-003	10143693	2036-04-05	U-2458	2018-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-003	10143693	2036-04-05	U-2457	2018-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-004	10143693	2036-04-05	U-2458	2018-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-004	10143693	2036-04-05	U-2457	2018-12-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-005	11304951	2041-05-07	U-3349	2022-04-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-005	11324751	2041-05-07	U-3359	2022-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-005	12208100	2041-05-07	U-3359	2025-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-005	12208100	2041-05-07	U-4110	2025-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-005	11666697	2041-11-24	U-3626	2023-06-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-006	11304951	2041-05-07	U-3349	2022-04-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-006	11324751	2041-05-07	U-3359	2022-05-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-006	12208100	2041-05-07	U-4110	2025-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-006	12208100	2041-05-07	U-3359	2025-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207946-006	11666697	2041-11-24	U-3626	2023-06-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207946-001	10143693	2036-04-05	U-2458	2018-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207946-001	10143693	2036-04-05	U-2457	2018-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207946-002	10143693	2036-04-05	U-2457	2018-12-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207946-002	10143693	2036-04-05	U-2458	2018-12-18	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207946-005	NS	2024-08-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207946-006	NS	2024-08-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207946-005	NS	2024-08-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207946-006	NS	2024-08-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207946-005	NS	2024-08-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207946-006	NS	2024-08-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207946-005	NS	2024-08-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207946-006	NS	2024-08-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N207946-005	NS	2024-08-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N207946-006	NS	2024-08-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207946-005	NS	2024-08-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N207946-006	NS	2024-08-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207946-005	NS	2024-08-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N207946-006	NS	2024-08-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207946-005	NS	2024-08-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N207946-006	NS	2024-08-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N207946-005	NS	2024-08-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N207946-006	NS	2024-08-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207946-005	NS	2024-08-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N207946-006	NS	2024-08-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N207946-005	NS	2024-08-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N207946-006	NS	2024-08-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N207946-005	NS	2024-08-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N207946-006	NS	2024-08-30	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N207946-005	NS	2024-08-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N207946-006	NS	2024-08-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N207946-005	NS	2024-08-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N207946-006	NS	2024-08-30	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N207946-005	NS	2024-08-30	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N207946-006	NS	2024-08-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N207946-005	NS	2024-08-30	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N207946-006	NS	2024-08-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N207946-005	NS	2024-08-30	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N207946-006	NS	2024-08-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N207946-005	NS	2024-08-30	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N207946-006	NS	2024-08-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N207946-005	NS	2024-08-30	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N207946-006	NS	2024-08-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N207946-005	NS	2024-08-30	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N207946-006	NS	2024-08-30	`a67488948f0b…`

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
INVEGA HAFYERA	PALIPERIDONE PALMITATE	Janssen Pharmaceuticals, Inc	6cd61892-d2cb-434d-83ed-5c1b2c4e7a0b	2025-02-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 207946 application number: NDA207946 ndc (product): 50458-612 ndc (product): 50458-611
INVEGA TRINZA	PALIPERIDONE PALMITATE	Janssen Pharmaceuticals, Inc	c39e65d7-fa44-4e4c-8b12-a654d3ed0eae	2025-02-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 207946 application number: NDA207946 ndc (product): 50458-607 ndc (product): 50458-608 ndc (product): 50458-609 ndc (product): 50458-606

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 40 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50458-606	INVEGA TRINZA	paliperidone palmitate	Janssen Pharmaceuticals, Inc	NDA	Current
50458-606	INVEGA TRINZA	paliperidone palmitate	Janssen Pharmaceuticals, Inc	NDA	Current
50458-606	INVEGA TRINZA	paliperidone palmitate	Janssen Pharmaceuticals, Inc	NDA	Current
50458-606	INVEGA TRINZA	paliperidone palmitate	Janssen Pharmaceuticals, Inc	NDA	Current
50458-606	INVEGA TRINZA	paliperidone palmitate	Janssen Pharmaceuticals, Inc	NDA	Current
50458-606	INVEGA TRINZA	paliperidone palmitate	Janssen Pharmaceuticals, Inc	NDA	Current
50458-606	INVEGA TRINZA	paliperidone palmitate	Janssen Pharmaceuticals, Inc	NDA	Current
50458-606	INVEGA TRINZA	paliperidone palmitate	Janssen Pharmaceuticals, Inc	NDA	Current
50458-606	INVEGA TRINZA	paliperidone palmitate	Janssen Pharmaceuticals, Inc	NDA	Current
50458-607	INVEGA TRINZA	paliperidone palmitate	Janssen Pharmaceuticals, Inc	NDA	Current
50458-607	INVEGA TRINZA	paliperidone palmitate	Janssen Pharmaceuticals, Inc	NDA	Current
50458-607	INVEGA TRINZA	paliperidone palmitate	Janssen Pharmaceuticals, Inc	NDA	Current
50458-607	INVEGA TRINZA	paliperidone palmitate	Janssen Pharmaceuticals, Inc	NDA	Current
50458-607	INVEGA TRINZA	paliperidone palmitate	Janssen Pharmaceuticals, Inc	NDA	Current
50458-607	INVEGA TRINZA	paliperidone palmitate	Janssen Pharmaceuticals, Inc	NDA	Current
50458-607	INVEGA TRINZA	paliperidone palmitate	Janssen Pharmaceuticals, Inc	NDA	Current
50458-607	INVEGA TRINZA	paliperidone palmitate	Janssen Pharmaceuticals, Inc	NDA	Current
50458-607	INVEGA TRINZA	paliperidone palmitate	Janssen Pharmaceuticals, Inc	NDA	Current
50458-608	INVEGA TRINZA	paliperidone palmitate	Janssen Pharmaceuticals, Inc	NDA	Current
50458-608	INVEGA TRINZA	paliperidone palmitate	Janssen Pharmaceuticals, Inc	NDA	Current
50458-608	INVEGA TRINZA	paliperidone palmitate	Janssen Pharmaceuticals, Inc	NDA	Current
50458-608	INVEGA TRINZA	paliperidone palmitate	Janssen Pharmaceuticals, Inc	NDA	Current
50458-608	INVEGA TRINZA	paliperidone palmitate	Janssen Pharmaceuticals, Inc	NDA	Current
50458-608	INVEGA TRINZA	paliperidone palmitate	Janssen Pharmaceuticals, Inc	NDA	Current
50458-608	INVEGA TRINZA	paliperidone palmitate	Janssen Pharmaceuticals, Inc	NDA	Current
50458-608	INVEGA TRINZA	paliperidone palmitate	Janssen Pharmaceuticals, Inc	NDA	Current
50458-608	INVEGA TRINZA	paliperidone palmitate	Janssen Pharmaceuticals, Inc	NDA	Current
50458-609	INVEGA TRINZA	paliperidone palmitate	Janssen Pharmaceuticals, Inc	NDA	Current
50458-609	INVEGA TRINZA	paliperidone palmitate	Janssen Pharmaceuticals, Inc	NDA	Current
50458-609	INVEGA TRINZA	paliperidone palmitate	Janssen Pharmaceuticals, Inc	NDA	Current
50458-609	INVEGA TRINZA	paliperidone palmitate	Janssen Pharmaceuticals, Inc	NDA	Current
50458-609	INVEGA TRINZA	paliperidone palmitate	Janssen Pharmaceuticals, Inc	NDA	Current
50458-609	INVEGA TRINZA	paliperidone palmitate	Janssen Pharmaceuticals, Inc	NDA	Current
50458-609	INVEGA TRINZA	paliperidone palmitate	Janssen Pharmaceuticals, Inc	NDA	Current
50458-609	INVEGA TRINZA	paliperidone palmitate	Janssen Pharmaceuticals, Inc	NDA	Current
50458-609	INVEGA TRINZA	paliperidone palmitate	Janssen Pharmaceuticals, Inc	NDA	Current
50458-611	INVEGA HAFYERA	paliperidone palmitate	Janssen Pharmaceuticals, Inc	NDA	Current
50458-611	INVEGA HAFYERA	paliperidone palmitate	Janssen Pharmaceuticals, Inc	NDA	Current
50458-612	INVEGA HAFYERA	paliperidone palmitate	Janssen Pharmaceuticals, Inc	NDA	Current
50458-612	INVEGA HAFYERA	paliperidone palmitate	Janssen Pharmaceuticals, Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81038	SUPPL	2025-02-12
81070	SUPPL	2025-02-06
79631	SUPPL	2024-09-16
79630	SUPPL	2024-09-16
79612	SUPPL	2024-09-16
79611	SUPPL	2024-09-16
68508	SUPPL	2021-09-01
68496	SUPPL	2021-08-31
68342	SUPPL	2021-08-11
68328	SUPPL	2021-08-10
66267	SUPPL	2021-02-17
66263	SUPPL	2021-02-17
57565	SUPPL	2019-02-13
57366	SUPPL	2019-01-28
55564	SUPPL	2018-09-21
55056	SUPPL	2018-07-30
47409	SUPPL	2017-03-02
47317	SUPPL	2017-02-24
40601	SUPPL	2016-03-03
10635	SUPPL	2016-03-03
44965	ORIG	2016-02-08
23042	ORIG	2016-02-08
10634	ORIG	2015-05-21
19975	ORIG	2015-05-20