Application 202971

Type: NDA
Sponsor: OTSUKA PHARM CO LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ABILIFY MAINTENA KIT	ARIPIPRAZOLE	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	300MG/VIAL	Yes	No
002	ABILIFY MAINTENA KIT	ARIPIPRAZOLE	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	400MG/VIAL	Yes	Yes
003	ABILIFY MAINTENA KIT	ARIPIPRAZOLE	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	300MG	Yes	No
004	ABILIFY MAINTENA KIT	ARIPIPRAZOLE	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	400MG	Yes	No

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

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	RLD / RS	Approval date
N202971-001	ABILIFY MAINTENA KIT	ARIPIPRAZOLE	300MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2013-02-28
N202971-002	ABILIFY MAINTENA KIT	ARIPIPRAZOLE	400MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2013-02-28
N202971-003	ABILIFY MAINTENA KIT	ARIPIPRAZOLE	300MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2014-09-29
N202971-004	ABILIFY MAINTENA KIT	ARIPIPRAZOLE	400MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2014-09-29

Orange Book patents#

Current patent rows page 1 of 1 · 68 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N202971-001	10980803	2033-09-24	U-1632		2021-05-19
N202971-001	10980803	2033-09-24	U-543		2021-05-19
N202971-001	11154553	2033-09-24	U-1632		2021-11-17
N202971-001	11154553	2033-09-24	U-3245		2021-11-17
N202971-001	11154553	2033-09-24	U-814		2021-11-17
N202971-001	11344547	2033-09-24	U-1632		2022-06-24
N202971-001	11344547	2033-09-24	U-3245		2022-06-24
N202971-001	11344547	2033-09-24	U-814		2022-06-24
N202971-001	11400087	2033-09-24	U-1632		2022-08-29
N202971-001	11400087	2033-09-24	U-3245		2022-08-29
N202971-001	11400087	2033-09-24	U-814		2022-08-29
N202971-001	10525057	2034-03-08	U-1632		2020-01-31
N202971-001	10525057	2034-03-08	U-2723		2020-01-31
N202971-001	10525057	2034-03-08	U-543		2020-01-31
N202971-001	11648347	2034-04-06		Drug product	2023-06-15
N202971-001	12691056	2041-04-01	U-3245		2026-08-26
N202971-001	12691056	2041-04-01	U-814		2026-08-26
N202971-002	10980803	2033-09-24	U-1632		2021-05-19
N202971-002	10980803	2033-09-24	U-543		2021-05-19
N202971-002	11154553	2033-09-24	U-1632		2021-11-17
N202971-002	11154553	2033-09-24	U-3245		2021-11-17
N202971-002	11154553	2033-09-24	U-814		2021-11-17
N202971-002	11344547	2033-09-24	U-1632		2022-06-24
N202971-002	11344547	2033-09-24	U-3245		2022-06-24
N202971-002	11344547	2033-09-24	U-814		2022-06-24
N202971-002	11400087	2033-09-24	U-1632		2022-08-29
N202971-002	11400087	2033-09-24	U-3245		2022-08-29
N202971-002	11400087	2033-09-24	U-814		2022-08-29
N202971-002	10525057	2034-03-08	U-1632		2020-01-31
N202971-002	10525057	2034-03-08	U-2723		2020-01-31
N202971-002	10525057	2034-03-08	U-543		2020-01-31
N202971-002	11648347	2034-04-06		Drug product	2023-06-15
N202971-002	12691056	2041-04-01	U-3245		2026-08-26
N202971-002	12691056	2041-04-01	U-814		2026-08-26
N202971-003	10980803	2033-09-24	U-1632		2021-05-19
N202971-003	10980803	2033-09-24	U-543		2021-05-19
N202971-003	11154553	2033-09-24	U-1632		2021-11-17
N202971-003	11154553	2033-09-24	U-3245		2021-11-17
N202971-003	11154553	2033-09-24	U-814		2021-11-17
N202971-003	11344547	2033-09-24	U-1632		2022-06-24
N202971-003	11344547	2033-09-24	U-3245		2022-06-24
N202971-003	11344547	2033-09-24	U-814		2022-06-24
N202971-003	11400087	2033-09-24	U-1632		2022-08-29
N202971-003	11400087	2033-09-24	U-3245		2022-08-29
N202971-003	11400087	2033-09-24	U-814		2022-08-29
N202971-003	10525057	2034-03-08	U-1632		2020-01-31
N202971-003	10525057	2034-03-08	U-2723		2020-01-31
N202971-003	10525057	2034-03-08	U-543		2020-01-31
N202971-003	11648347	2034-04-06		Drug product	2023-06-15
N202971-003	12691056	2041-04-01	U-3245		2026-08-26
N202971-003	12691056	2041-04-01	U-814		2026-08-26
N202971-004	10980803	2033-09-24	U-1632		2021-05-19
N202971-004	10980803	2033-09-24	U-543		2021-05-19
N202971-004	11154553	2033-09-24	U-1632		2021-11-17
N202971-004	11154553	2033-09-24	U-3245		2021-11-17
N202971-004	11154553	2033-09-24	U-814		2021-11-17
N202971-004	11344547	2033-09-24	U-1632		2022-06-24
N202971-004	11344547	2033-09-24	U-3245		2022-06-24
N202971-004	11344547	2033-09-24	U-814		2022-06-24
N202971-004	11400087	2033-09-24	U-1632		2022-08-29
N202971-004	11400087	2033-09-24	U-3245		2022-08-29
N202971-004	11400087	2033-09-24	U-814		2022-08-29
N202971-004	10525057	2034-03-08	U-1632		2020-01-31
N202971-004	10525057	2034-03-08	U-2723		2020-01-31
N202971-004	10525057	2034-03-08	U-543		2020-01-31
N202971-004	11648347	2034-04-06		Drug product	2023-06-15
N202971-004	12691056	2041-04-01	U-3245		2026-08-26
N202971-004	12691056	2041-04-01	U-814		2026-08-26

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 · 172 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
2026-09-14 22:38:34	2026-08	N202971-001	ABILIFY MAINTENA KIT	300MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2013-02-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-002	ABILIFY MAINTENA KIT	400MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2013-02-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-003	ABILIFY MAINTENA KIT	300MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2014-09-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-004	ABILIFY MAINTENA KIT	400MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2014-09-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N202971-001	ABILIFY MAINTENA KIT	300MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2013-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202971-002	ABILIFY MAINTENA KIT	400MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2013-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202971-003	ABILIFY MAINTENA KIT	300MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2014-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202971-004	ABILIFY MAINTENA KIT	400MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2014-09-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202971-001	ABILIFY MAINTENA KIT	300MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2013-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202971-002	ABILIFY MAINTENA KIT	400MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2013-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202971-003	ABILIFY MAINTENA KIT	300MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2014-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202971-004	ABILIFY MAINTENA KIT	400MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2014-09-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202971-001	ABILIFY MAINTENA KIT	300MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2013-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202971-002	ABILIFY MAINTENA KIT	400MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2013-02-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202971-003	ABILIFY MAINTENA KIT	300MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2014-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202971-004	ABILIFY MAINTENA KIT	400MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2014-09-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202971-001	ABILIFY MAINTENA KIT	300MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2013-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202971-002	ABILIFY MAINTENA KIT	400MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2013-02-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202971-003	ABILIFY MAINTENA KIT	300MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2014-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202971-004	ABILIFY MAINTENA KIT	400MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2014-09-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202971-001	ABILIFY MAINTENA KIT	300MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2013-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202971-002	ABILIFY MAINTENA KIT	400MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2013-02-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202971-003	ABILIFY MAINTENA KIT	300MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2014-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202971-004	ABILIFY MAINTENA KIT	400MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2014-09-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202971-001	ABILIFY MAINTENA KIT	300MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2013-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202971-002	ABILIFY MAINTENA KIT	400MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2013-02-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202971-003	ABILIFY MAINTENA KIT	300MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2014-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202971-004	ABILIFY MAINTENA KIT	400MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2014-09-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202971-001	ABILIFY MAINTENA KIT	300MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AP	RLD	2013-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202971-002	ABILIFY MAINTENA KIT	400MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AP	RLD, RS	2013-02-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202971-003	ABILIFY MAINTENA KIT	300MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2014-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202971-004	ABILIFY MAINTENA KIT	400MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2014-09-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202971-001	ABILIFY MAINTENA KIT	300MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AP	RLD	2013-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202971-002	ABILIFY MAINTENA KIT	400MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	AP	RLD, RS	2013-02-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202971-003	ABILIFY MAINTENA KIT	300MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2014-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202971-004	ABILIFY MAINTENA KIT	400MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2014-09-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202971-001	ABILIFY MAINTENA KIT	300MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2013-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202971-002	ABILIFY MAINTENA KIT	400MG/VIAL	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2013-02-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202971-003	ABILIFY MAINTENA KIT	300MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2014-09-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202971-004	ABILIFY MAINTENA KIT	400MG	FOR SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2014-09-29	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202971-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202971-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202971-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202971-002	AP	1	`2680178bc6a6…`

Observed Orange Book patent history#

Patent history page 1 of 89 · 3,528 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	N202971-001	10980803	2033-09-24	U-543		2021-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-001	10980803	2033-09-24	U-1632		2021-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-001	11154553	2033-09-24	U-1632		2021-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-001	11154553	2033-09-24	U-814		2021-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-001	11154553	2033-09-24	U-3245		2021-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-001	11344547	2033-09-24	U-1632		2022-06-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-001	11344547	2033-09-24	U-3245		2022-06-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-001	11344547	2033-09-24	U-814		2022-06-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-001	11400087	2033-09-24	U-3245		2022-08-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-001	11400087	2033-09-24	U-814		2022-08-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-001	11400087	2033-09-24	U-1632		2022-08-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-001	10525057	2034-03-08	U-543		2020-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-001	10525057	2034-03-08	U-1632		2020-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-001	10525057	2034-03-08	U-2723		2020-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-001	11648347	2034-04-06		Drug product	2023-06-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-001	12691056	2041-04-01	U-814		2026-08-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-001	12691056	2041-04-01	U-3245		2026-08-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-002	10980803	2033-09-24	U-543		2021-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-002	10980803	2033-09-24	U-1632		2021-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-002	11154553	2033-09-24	U-1632		2021-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-002	11154553	2033-09-24	U-814		2021-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-002	11154553	2033-09-24	U-3245		2021-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-002	11344547	2033-09-24	U-1632		2022-06-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-002	11344547	2033-09-24	U-3245		2022-06-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-002	11344547	2033-09-24	U-814		2022-06-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-002	11400087	2033-09-24	U-814		2022-08-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-002	11400087	2033-09-24	U-3245		2022-08-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-002	11400087	2033-09-24	U-1632		2022-08-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-002	10525057	2034-03-08	U-2723		2020-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-002	10525057	2034-03-08	U-1632		2020-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-002	10525057	2034-03-08	U-543		2020-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-002	11648347	2034-04-06		Drug product	2023-06-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-002	12691056	2041-04-01	U-814		2026-08-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-002	12691056	2041-04-01	U-3245		2026-08-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-003	10980803	2033-09-24	U-543		2021-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-003	10980803	2033-09-24	U-1632		2021-05-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-003	11154553	2033-09-24	U-1632		2021-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-003	11154553	2033-09-24	U-814		2021-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-003	11154553	2033-09-24	U-3245		2021-11-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202971-003	11344547	2033-09-24	U-1632		2022-06-24	`84e616aacf4f…`

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	N202971-001	I-746	2020-07-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202971-002	I-746	2020-07-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202971-003	I-746	2020-07-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202971-004	I-746	2020-07-27	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N202971-001	I-746	2020-07-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N202971-002	I-746	2020-07-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N202971-003	I-746	2020-07-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N202971-004	I-746	2020-07-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202971-001	I-746	2020-07-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N202971-002	I-746	2020-07-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N202971-003	I-746	2020-07-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N202971-004	I-746	2020-07-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N202971-001	I-746	2020-07-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N202971-002	I-746	2020-07-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N202971-003	I-746	2020-07-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N202971-004	I-746	2020-07-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N202971-001	I-746	2020-07-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N202971-002	I-746	2020-07-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N202971-003	I-746	2020-07-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N202971-004	I-746	2020-07-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N202971-001	I-746	2020-07-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N202971-002	I-746	2020-07-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N202971-003	I-746	2020-07-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N202971-004	I-746	2020-07-27	`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
ABILIFY MAINTENA	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6	2026-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 202971 application number: NDA202971 ndc (product): 59148-072 ndc (product): 59148-045

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 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59148-018	ABILIFY MAINTENA	aripiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-018	ABILIFY MAINTENA	aripiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-018	ABILIFY MAINTENA	aripiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-018	ABILIFY MAINTENA	aripiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-018	ABILIFY MAINTENA	aripiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-019	ABILIFY MAINTENA	aripiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-019	ABILIFY MAINTENA	aripiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-019	ABILIFY MAINTENA	aripiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-019	ABILIFY MAINTENA	aripiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-019	ABILIFY MAINTENA	aripiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-045	ABILIFY MAINTENA	aripiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-045	ABILIFY MAINTENA	aripiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-045	ABILIFY MAINTENA	aripiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-045	ABILIFY MAINTENA	aripiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-045	ABILIFY MAINTENA	aripiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-072	ABILIFY MAINTENA	aripiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-072	ABILIFY MAINTENA	aripiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-072	ABILIFY MAINTENA	aripiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-072	ABILIFY MAINTENA	aripiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-072	ABILIFY MAINTENA	aripiprazole	Otsuka America Pharmaceutical, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81815	SUPPL	2026-03-02
84874	SUPPL	2026-01-29
84873	SUPPL	2026-01-29
82920	SUPPL	2025-07-25
82917	SUPPL	2025-07-24
81892	SUPPL	2025-04-09
81816	SUPPL	2025-04-03
81134	SUPPL	2025-02-07
80944	SUPPL	2025-02-05
61808	SUPPL	2020-02-06
61793	SUPPL	2020-02-06
61807	SUPPL	2020-02-05
49289	SUPPL	2017-08-08
49180	SUPPL	2017-08-02
49150	SUPPL	2017-07-31
47428	SUPPL	2017-03-02
47323	SUPPL	2017-02-24
45101	SUPPL	2016-08-23
45146	SUPPL	2016-08-18
19404	SUPPL	2016-01-22
10140	SUPPL	2016-01-20
40245	SUPPL	2015-07-30
32344	SUPPL	2015-07-30
43418	SUPPL	2015-07-27
19403	SUPPL	2014-12-10
10139	SUPPL	2014-12-09
40244	SUPPL	2014-09-30
40243	SUPPL	2014-06-03
44872	ORIG	2013-04-11
22904	ORIG	2013-04-11
19402	ORIG	2013-03-15
10138	ORIG	2013-03-01