Application 022264

Type: NDA
Sponsor: JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	INVEGA SUSTENNA	PALIPERIDONE PALMITATE	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	39MG/0.25ML (39MG/0.25ML)	Yes	No
002	INVEGA SUSTENNA	PALIPERIDONE PALMITATE	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	78MG/0.5ML (78MG/0.5ML)	Yes	No
003	INVEGA SUSTENNA	PALIPERIDONE PALMITATE	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	117MG/0.75ML (117MG/0.75ML)	Yes	No
004	INVEGA SUSTENNA	PALIPERIDONE PALMITATE	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	156MG/ML (156MG/ML)	Yes	Yes
005	INVEGA SUSTENNA	PALIPERIDONE PALMITATE	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	234MG/1.5ML (156MG/ML)	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	RLD / RS	Approval date
N022264-001	INVEGA SUSTENNA	PALIPERIDONE PALMITATE	39MG/0.25ML (39MG/0.25ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2009-07-31
N022264-002	INVEGA SUSTENNA	PALIPERIDONE PALMITATE	78MG/0.5ML (78MG/0.5ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2009-07-31
N022264-003	INVEGA SUSTENNA	PALIPERIDONE PALMITATE	117MG/0.75ML (117MG/0.75ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2009-07-31
N022264-004	INVEGA SUSTENNA	PALIPERIDONE PALMITATE	156MG/ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2009-07-31
N022264-005	INVEGA SUSTENNA	PALIPERIDONE PALMITATE	234MG/1.5ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2009-07-31

Orange Book patents#

Current patent rows page 1 of 1 · 10 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N022264-001	9439906	2031-01-26	U-2757	2016-10-11
N022264-001	9439906	2031-01-26	U-2758	2016-10-11
N022264-002	9439906	2031-01-26	U-2757	2016-10-11
N022264-002	9439906	2031-01-26	U-2758	2016-10-11
N022264-003	9439906	2031-01-26	U-2757	2016-10-11
N022264-003	9439906	2031-01-26	U-2758	2016-10-11
N022264-004	9439906	2031-01-26	U-2757	2016-10-11
N022264-004	9439906	2031-01-26	U-2758	2016-10-11
N022264-005	9439906	2031-01-26	U-2757	2016-10-11
N022264-005	9439906	2031-01-26	U-2758	2016-10-11

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	N022264-001	INVEGA SUSTENNA	39MG/0.25ML (39MG/0.25ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2009-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022264-002	INVEGA SUSTENNA	78MG/0.5ML (78MG/0.5ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2009-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022264-003	INVEGA SUSTENNA	117MG/0.75ML (117MG/0.75ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2009-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022264-004	INVEGA SUSTENNA	156MG/ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2009-07-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022264-005	INVEGA SUSTENNA	234MG/1.5ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2009-07-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022264-001	INVEGA SUSTENNA	39MG/0.25ML (39MG/0.25ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2009-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022264-002	INVEGA SUSTENNA	78MG/0.5ML (78MG/0.5ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2009-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022264-003	INVEGA SUSTENNA	117MG/0.75ML (117MG/0.75ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2009-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022264-004	INVEGA SUSTENNA	156MG/ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2009-07-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022264-005	INVEGA SUSTENNA	234MG/1.5ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2009-07-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022264-001	INVEGA SUSTENNA	39MG/0.25ML (39MG/0.25ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AB	RLD	2009-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022264-002	INVEGA SUSTENNA	78MG/0.5ML (78MG/0.5ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AB	RLD	2009-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022264-003	INVEGA SUSTENNA	117MG/0.75ML (117MG/0.75ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AB	RLD	2009-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022264-004	INVEGA SUSTENNA	156MG/ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AB	RLD, RS	2009-07-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022264-005	INVEGA SUSTENNA	234MG/1.5ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AB	RLD	2009-07-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022264-001	INVEGA SUSTENNA	39MG/0.25ML (39MG/0.25ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AB	RLD	2009-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022264-002	INVEGA SUSTENNA	78MG/0.5ML (78MG/0.5ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AB	RLD	2009-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022264-003	INVEGA SUSTENNA	117MG/0.75ML (117MG/0.75ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AB	RLD	2009-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022264-004	INVEGA SUSTENNA	156MG/ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AB	RLD, RS	2009-07-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022264-005	INVEGA SUSTENNA	234MG/1.5ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AB	RLD	2009-07-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022264-001	INVEGA SUSTENNA	39MG/0.25ML (39MG/0.25ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AB	RLD	2009-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022264-002	INVEGA SUSTENNA	78MG/0.5ML (78MG/0.5ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AB	RLD	2009-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022264-003	INVEGA SUSTENNA	117MG/0.75ML (117MG/0.75ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AB	RLD	2009-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022264-004	INVEGA SUSTENNA	156MG/ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AB	RLD, RS	2009-07-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022264-005	INVEGA SUSTENNA	234MG/1.5ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AB	RLD	2009-07-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022264-001	INVEGA SUSTENNA	39MG/0.25ML (39MG/0.25ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AB	RLD	2009-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022264-002	INVEGA SUSTENNA	78MG/0.5ML (78MG/0.5ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AB	RLD	2009-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022264-003	INVEGA SUSTENNA	117MG/0.75ML (117MG/0.75ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AB	RLD	2009-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022264-004	INVEGA SUSTENNA	156MG/ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AB	RLD, RS	2009-07-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022264-005	INVEGA SUSTENNA	234MG/1.5ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AB	RLD	2009-07-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022264-001	INVEGA SUSTENNA	39MG/0.25ML (39MG/0.25ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AB	RLD	2009-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022264-002	INVEGA SUSTENNA	78MG/0.5ML (78MG/0.5ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AB	RLD	2009-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022264-003	INVEGA SUSTENNA	117MG/0.75ML (117MG/0.75ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AB	RLD	2009-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022264-004	INVEGA SUSTENNA	156MG/ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AB	RLD, RS	2009-07-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022264-005	INVEGA SUSTENNA	234MG/1.5ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AB	RLD	2009-07-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022264-001	INVEGA SUSTENNA	39MG/0.25ML (39MG/0.25ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AB	RLD	2009-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022264-002	INVEGA SUSTENNA	78MG/0.5ML (78MG/0.5ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AB	RLD	2009-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022264-003	INVEGA SUSTENNA	117MG/0.75ML (117MG/0.75ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AB	RLD	2009-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022264-004	INVEGA SUSTENNA	156MG/ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AB	RLD, RS	2009-07-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022264-005	INVEGA SUSTENNA	234MG/1.5ML (156MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AB	RLD	2009-07-31	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 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	N022264-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022264-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022264-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022264-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022264-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022264-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022264-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022264-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022264-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022264-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022264-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022264-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022264-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022264-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022264-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022264-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022264-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022264-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022264-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022264-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022264-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022264-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022264-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022264-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022264-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022264-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022264-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022264-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022264-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022264-005	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022264-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022264-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022264-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022264-004	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022264-005	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022264-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022264-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022264-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022264-004	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022264-005	AB	1	`d06236e962d9…`

Observed Orange Book patent history#

Patent history page 1 of 20 · 770 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	N022264-001	9439906	2031-01-26	U-2758	2016-10-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022264-001	9439906	2031-01-26	U-2757	2016-10-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022264-002	9439906	2031-01-26	U-2757	2016-10-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022264-002	9439906	2031-01-26	U-2758	2016-10-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022264-003	9439906	2031-01-26	U-2758	2016-10-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022264-003	9439906	2031-01-26	U-2757	2016-10-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022264-004	9439906	2031-01-26	U-2757	2016-10-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022264-004	9439906	2031-01-26	U-2758	2016-10-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022264-005	9439906	2031-01-26	U-2758	2016-10-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022264-005	9439906	2031-01-26	U-2757	2016-10-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022264-001	9439906	2031-01-26	U-2758	2016-10-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022264-001	9439906	2031-01-26	U-2757	2016-10-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022264-002	9439906	2031-01-26	U-2757	2016-10-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022264-002	9439906	2031-01-26	U-2758	2016-10-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022264-003	9439906	2031-01-26	U-2758	2016-10-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022264-003	9439906	2031-01-26	U-2757	2016-10-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022264-004	9439906	2031-01-26	U-2757	2016-10-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022264-004	9439906	2031-01-26	U-2758	2016-10-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022264-005	9439906	2031-01-26	U-2758	2016-10-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022264-005	9439906	2031-01-26	U-2757	2016-10-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022264-001	9439906	2031-01-26	U-1901	2016-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022264-001	9439906	2031-01-26	U-543	2016-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022264-001	9439906	2031-01-26	U-2758	2016-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022264-001	9439906	2031-01-26	U-2757	2016-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022264-002	9439906	2031-01-26	U-543	2016-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022264-002	9439906	2031-01-26	U-1901	2016-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022264-002	9439906	2031-01-26	U-2757	2016-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022264-002	9439906	2031-01-26	U-2758	2016-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022264-003	9439906	2031-01-26	U-543	2016-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022264-003	9439906	2031-01-26	U-1901	2016-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022264-003	9439906	2031-01-26	U-2758	2016-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022264-003	9439906	2031-01-26	U-2757	2016-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022264-004	9439906	2031-01-26	U-1901	2016-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022264-004	9439906	2031-01-26	U-543	2016-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022264-004	9439906	2031-01-26	U-2757	2016-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022264-004	9439906	2031-01-26	U-2758	2016-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022264-005	9439906	2031-01-26	U-2758	2016-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022264-005	9439906	2031-01-26	U-2757	2016-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022264-005	9439906	2031-01-26	U-1901	2016-10-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022264-005	9439906	2031-01-26	U-543	2016-10-11	`6a471c1ec25d…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022264-001	M-215	2020-12-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022264-002	M-215	2020-12-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022264-003	M-215	2020-12-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022264-004	M-215	2020-12-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022264-005	M-215	2020-12-20	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N022264-001	M-215	2020-12-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022264-002	M-215	2020-12-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022264-003	M-215	2020-12-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022264-004	M-215	2020-12-20	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022264-005	M-215	2020-12-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022264-001	M-215	2020-12-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022264-002	M-215	2020-12-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022264-003	M-215	2020-12-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022264-004	M-215	2020-12-20	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022264-005	M-215	2020-12-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022264-001	M-215	2020-12-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022264-002	M-215	2020-12-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022264-003	M-215	2020-12-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022264-004	M-215	2020-12-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N022264-005	M-215	2020-12-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022264-001	M-215	2020-12-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022264-002	M-215	2020-12-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022264-003	M-215	2020-12-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022264-004	M-215	2020-12-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N022264-005	M-215	2020-12-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022264-001	M-215	2020-12-20	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022264-002	M-215	2020-12-20	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022264-003	M-215	2020-12-20	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022264-004	M-215	2020-12-20	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N022264-005	M-215	2020-12-20	`ea99ee380514…`

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 SUSTENNA	PALIPERIDONE PALMITATE	Janssen Pharmaceuticals, Inc.	1af14e42-951d-414d-8564-5d5fce138554	2025-02-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022264 application number: NDA022264 ndc (product): 50458-561 ndc (product): 50458-562 ndc (product): 50458-563 ndc (product): 50458-560 ndc (product): 50458-564

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50458-560	INVEGA SUSTENNA	paliperidone palmitate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-560	INVEGA SUSTENNA	paliperidone palmitate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-560	INVEGA SUSTENNA	paliperidone palmitate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-560	INVEGA SUSTENNA	paliperidone palmitate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-560	INVEGA SUSTENNA	paliperidone palmitate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-560	INVEGA SUSTENNA	paliperidone palmitate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-561	INVEGA SUSTENNA	paliperidone palmitate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-561	INVEGA SUSTENNA	paliperidone palmitate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-561	INVEGA SUSTENNA	paliperidone palmitate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-561	INVEGA SUSTENNA	paliperidone palmitate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-561	INVEGA SUSTENNA	paliperidone palmitate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-561	INVEGA SUSTENNA	paliperidone palmitate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-562	INVEGA SUSTENNA	paliperidone palmitate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-562	INVEGA SUSTENNA	paliperidone palmitate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-562	INVEGA SUSTENNA	paliperidone palmitate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-562	INVEGA SUSTENNA	paliperidone palmitate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-562	INVEGA SUSTENNA	paliperidone palmitate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-562	INVEGA SUSTENNA	paliperidone palmitate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-563	INVEGA SUSTENNA	paliperidone palmitate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-563	INVEGA SUSTENNA	paliperidone palmitate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-563	INVEGA SUSTENNA	paliperidone palmitate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-563	INVEGA SUSTENNA	paliperidone palmitate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-563	INVEGA SUSTENNA	paliperidone palmitate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-563	INVEGA SUSTENNA	paliperidone palmitate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-564	INVEGA SUSTENNA	paliperidone palmitate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-564	INVEGA SUSTENNA	paliperidone palmitate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-564	INVEGA SUSTENNA	paliperidone palmitate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-564	INVEGA SUSTENNA	paliperidone palmitate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-564	INVEGA SUSTENNA	paliperidone palmitate	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-564	INVEGA SUSTENNA	paliperidone palmitate	Janssen Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80906	SUPPL	2025-03-12
81069	SUPPL	2025-02-06
79626	SUPPL	2024-09-16
79610	SUPPL	2024-09-16
71768	SUPPL	2022-08-10
71671	SUPPL	2022-08-01
68346	SUPPL	2021-08-11
68324	SUPPL	2021-08-10
66266	SUPPL	2021-02-17
66262	SUPPL	2021-02-17
62855	SUPPL	2020-05-08
57564	SUPPL	2019-02-13
57365	SUPPL	2019-01-28
55563	SUPPL	2018-09-21
55055	SUPPL	2018-07-30
50924	SUPPL	2017-12-27
50849	SUPPL	2017-12-26
48739	SUPPL	2017-06-16
48738	SUPPL	2017-06-16
47408	SUPPL	2017-03-02
47316	SUPPL	2017-02-24
17169	SUPPL	2016-03-03
7134	SUPPL	2016-03-03
17168	SUPPL	2015-06-11
7133	SUPPL	2015-06-10
38465	SUPPL	2014-12-20
17167	SUPPL	2014-12-20
29493	SUPPL	2014-11-14
29492	SUPPL	2014-11-14
17166	SUPPL	2014-05-02
29491	SUPPL	2014-05-01
38463	SUPPL	2012-08-31
29489	SUPPL	2012-08-30
44177	ORIG	2011-12-22
38464	SUPPL	2011-09-30
29490	SUPPL	2011-09-28
7131	SUPPL	2011-06-24
38461	SUPPL	2011-06-16
7132	SUPPL	2010-12-07
38462	SUPPL	2010-12-04
7130	SUPPL	2010-05-18
38460	SUPPL	2010-05-17
44720	ORIG	2010-05-13
42473	ORIG	2010-05-13
17165	ORIG	2009-10-01
7129	ORIG	2009-08-17