Application 217006

Type: NDA
Sponsor: OTSUKA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ABILIFY ASIMTUFII	ARIPIPRAZOLE	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	720MG/2.4ML (300MG/ML)	Yes	No
002	ABILIFY ASIMTUFII	ARIPIPRAZOLE	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	960MG/3.2ML (300MG/ML)	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N217006-001	ABILIFY ASIMTUFII	ARIPIPRAZOLE	720MG/2.4ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2023-04-27
N217006-002	ABILIFY ASIMTUFII	ARIPIPRAZOLE	960MG/3.2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2023-04-27

Orange Book patents#

Current patent rows page 1 of 1 · 16 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N217006-001	10517951	2033-04-23	U-3245	Drug product	2023-05-25
N217006-001	10517951	2033-04-23	U-814	Drug product	2023-05-25
N217006-001	11097007	2033-04-23	U-3245	Drug product	2023-05-25
N217006-001	11097007	2033-04-23	U-814	Drug product	2023-05-25
N217006-001	11638757	2033-04-23	U-3245	Drug product	2023-05-25
N217006-001	11638757	2033-04-23	U-814	Drug product	2023-05-25
N217006-001	12016927	2033-04-23	U-3245	Drug product	2024-07-24
N217006-001	12016927	2033-04-23	U-543	Drug product	2024-07-24
N217006-002	10517951	2033-04-23	U-3245	Drug product	2023-05-25
N217006-002	10517951	2033-04-23	U-814	Drug product	2023-05-25
N217006-002	11097007	2033-04-23	U-3245	Drug product	2023-05-25
N217006-002	11097007	2033-04-23	U-814	Drug product	2023-05-25
N217006-002	11638757	2033-04-23	U-3245	Drug product	2023-05-25
N217006-002	11638757	2033-04-23	U-814	Drug product	2023-05-25
N217006-002	12016927	2033-04-23	U-3245	Drug product	2024-07-24
N217006-002	12016927	2033-04-23	U-543	Drug product	2024-07-24

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 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N217006-001	ABILIFY ASIMTUFII	720MG/2.4ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-04-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217006-002	ABILIFY ASIMTUFII	960MG/3.2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-04-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217006-001	ABILIFY ASIMTUFII	720MG/2.4ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-04-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217006-002	ABILIFY ASIMTUFII	960MG/3.2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-04-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217006-001	ABILIFY ASIMTUFII	720MG/2.4ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-04-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217006-002	ABILIFY ASIMTUFII	960MG/3.2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-04-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217006-001	ABILIFY ASIMTUFII	720MG/2.4ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-04-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217006-002	ABILIFY ASIMTUFII	960MG/3.2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-04-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217006-001	ABILIFY ASIMTUFII	720MG/2.4ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-04-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217006-002	ABILIFY ASIMTUFII	960MG/3.2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-04-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217006-001	ABILIFY ASIMTUFII	720MG/2.4ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-04-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217006-002	ABILIFY ASIMTUFII	960MG/3.2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-04-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217006-001	ABILIFY ASIMTUFII	720MG/2.4ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-04-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217006-002	ABILIFY ASIMTUFII	960MG/3.2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-04-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217006-001	ABILIFY ASIMTUFII	720MG/2.4ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-04-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217006-002	ABILIFY ASIMTUFII	960MG/3.2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-04-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217006-001	ABILIFY ASIMTUFII	720MG/2.4ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-04-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217006-002	ABILIFY ASIMTUFII	960MG/3.2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-04-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217006-001	ABILIFY ASIMTUFII	720MG/2.4ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-04-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217006-002	ABILIFY ASIMTUFII	960MG/3.2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-04-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217006-001	ABILIFY ASIMTUFII	720MG/2.4ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-04-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217006-002	ABILIFY ASIMTUFII	960MG/3.2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-04-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217006-001	ABILIFY ASIMTUFII	720MG/2.4ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-04-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N217006-002	ABILIFY ASIMTUFII	960MG/3.2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-04-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217006-001	ABILIFY ASIMTUFII	720MG/2.4ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-04-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217006-002	ABILIFY ASIMTUFII	960MG/3.2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-04-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217006-001	ABILIFY ASIMTUFII	720MG/2.4ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-04-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217006-002	ABILIFY ASIMTUFII	960MG/3.2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-04-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217006-001	ABILIFY ASIMTUFII	720MG/2.4ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-04-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217006-002	ABILIFY ASIMTUFII	960MG/3.2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-04-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217006-001	ABILIFY ASIMTUFII	720MG/2.4ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-04-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N217006-002	ABILIFY ASIMTUFII	960MG/3.2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-04-27	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217006-001	ABILIFY ASIMTUFII	720MG/2.4ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-04-27	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217006-002	ABILIFY ASIMTUFII	960MG/3.2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-04-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N217006-001	ABILIFY ASIMTUFII	720MG/2.4ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-04-27	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N217006-002	ABILIFY ASIMTUFII	960MG/3.2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-04-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N217006-001	ABILIFY ASIMTUFII	720MG/2.4ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-04-27	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N217006-002	ABILIFY ASIMTUFII	960MG/3.2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-04-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217006-001	ABILIFY ASIMTUFII	720MG/2.4ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-04-27	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217006-002	ABILIFY ASIMTUFII	960MG/3.2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-04-27	`a72a2bbeb626…`

Observed Orange Book patent history#

Patent history page 1 of 12 · 444 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N217006-001	10517951	2033-04-23	U-3245	Drug product	2023-05-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217006-001	10517951	2033-04-23	U-814	Drug product	2023-05-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217006-001	11097007	2033-04-23	U-3245	Drug product	2023-05-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217006-001	11097007	2033-04-23	U-814	Drug product	2023-05-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217006-001	11638757	2033-04-23	U-3245	Drug product	2023-05-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217006-001	11638757	2033-04-23	U-814	Drug product	2023-05-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217006-001	12016927	2033-04-23	U-3245	Drug product	2024-07-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217006-001	12016927	2033-04-23	U-543	Drug product	2024-07-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217006-002	10517951	2033-04-23	U-814	Drug product	2023-05-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217006-002	10517951	2033-04-23	U-3245	Drug product	2023-05-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217006-002	11097007	2033-04-23	U-814	Drug product	2023-05-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217006-002	11097007	2033-04-23	U-3245	Drug product	2023-05-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217006-002	11638757	2033-04-23	U-814	Drug product	2023-05-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217006-002	11638757	2033-04-23	U-3245	Drug product	2023-05-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217006-002	12016927	2033-04-23	U-543	Drug product	2024-07-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217006-002	12016927	2033-04-23	U-3245	Drug product	2024-07-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217006-001	10517951	2033-04-23	U-3245	Drug product	2023-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217006-001	10517951	2033-04-23	U-814	Drug product	2023-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217006-001	11097007	2033-04-23	U-3245	Drug product	2023-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217006-001	11097007	2033-04-23	U-814	Drug product	2023-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217006-001	11638757	2033-04-23	U-3245	Drug product	2023-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217006-001	11638757	2033-04-23	U-814	Drug product	2023-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217006-001	12016927	2033-04-23	U-3245	Drug product	2024-07-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217006-001	12016927	2033-04-23	U-543	Drug product	2024-07-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217006-002	10517951	2033-04-23	U-814	Drug product	2023-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217006-002	10517951	2033-04-23	U-3245	Drug product	2023-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217006-002	11097007	2033-04-23	U-814	Drug product	2023-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217006-002	11097007	2033-04-23	U-3245	Drug product	2023-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217006-002	11638757	2033-04-23	U-814	Drug product	2023-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217006-002	11638757	2033-04-23	U-3245	Drug product	2023-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217006-002	12016927	2033-04-23	U-543	Drug product	2024-07-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217006-002	12016927	2033-04-23	U-3245	Drug product	2024-07-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217006-001	10517951	2033-04-23	U-3245	Drug product	2023-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217006-001	10517951	2033-04-23	U-814	Drug product	2023-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217006-001	11097007	2033-04-23	U-3245	Drug product	2023-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217006-001	11097007	2033-04-23	U-814	Drug product	2023-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217006-001	11638757	2033-04-23	U-3245	Drug product	2023-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217006-001	11638757	2033-04-23	U-814	Drug product	2023-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217006-001	12016927	2033-04-23	U-3245	Drug product	2024-07-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217006-001	12016927	2033-04-23	U-543	Drug product	2024-07-24	`011fe1cb6892…`

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
Abilify Asimtufii	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc	da4c07fd-1130-4341-bb44-63acfa4162be	2025-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 217006 application number: NDA217006

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85204	SUPPL	2026-03-02
81893	SUPPL	2025-04-09
81143	SUPPL	2025-02-07
81018	SUPPL	2025-02-05
81017	SUPPL	2025-02-05
77509	ORIG	2024-02-16
74132	ORIG	2023-05-01
74119	ORIG	2023-04-28