Application 207202

Type: NDA
Sponsor: OTSUKA PHARM CO LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ABILIFY MYCITE KIT	ARIPIPRAZOLE	TABLET;ORAL	2MG	Yes	No
002	ABILIFY MYCITE KIT	ARIPIPRAZOLE	TABLET;ORAL	5MG	Yes	Yes
003	ABILIFY MYCITE KIT	ARIPIPRAZOLE	TABLET;ORAL	10MG	Yes	No
004	ABILIFY MYCITE KIT	ARIPIPRAZOLE	TABLET;ORAL	15MG	Yes	No
005	ABILIFY MYCITE KIT	ARIPIPRAZOLE	TABLET;ORAL	20MG	Yes	No
006	ABILIFY MYCITE KIT	ARIPIPRAZOLE	TABLET;ORAL	30MG	Yes	No

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

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
N207202-001	ABILIFY MYCITE KIT	ARIPIPRAZOLE	2MG	TABLET / ORAL	RLD	2017-11-13
N207202-002	ABILIFY MYCITE KIT	ARIPIPRAZOLE	5MG	TABLET / ORAL	RLD	2017-11-13
N207202-003	ABILIFY MYCITE KIT	ARIPIPRAZOLE	10MG	TABLET / ORAL	RLD	2017-11-13
N207202-004	ABILIFY MYCITE KIT	ARIPIPRAZOLE	15MG	TABLET / ORAL	RLD	2017-11-13
N207202-005	ABILIFY MYCITE KIT	ARIPIPRAZOLE	20MG	TABLET / ORAL	RLD	2017-11-13
N207202-006	ABILIFY MYCITE KIT	ARIPIPRAZOLE	30MG	TABLET / ORAL	RLD	2017-11-13

Orange Book patents#

Current patent rows page 1 of 3 · 162 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N207202-001	11476952	2026-04-28		Drug product	2022-11-09
N207202-001	9125939	2026-07-28	U-1749		2017-12-12
N207202-001	7978064	2026-09-14		Drug product	2017-12-12
N207202-001	8759350	2027-03-02	U-1529		2017-12-12
N207202-001	9444503	2027-11-19	U-2169	Drug product	2017-12-12
N207202-001	9119554	2028-12-16		Drug product	2017-12-12
N207202-001	9060708	2029-03-05		Drug product	2017-12-12
N207202-001	9258035	2029-03-05		Drug product	2017-12-12
N207202-001	8674825	2029-04-09	U-2170	Drug product	2017-12-12
N207202-001	8956288	2029-07-06	U-2167	Drug product	2017-12-12
N207202-001	10441194	2029-07-26		Drug product	2019-11-01
N207202-001	8945005	2029-08-19	U-2167	Drug product	2017-12-12
N207202-001	9433371	2029-09-15		Drug product	2017-12-12
N207202-001	8718193	2029-12-05		Drug product	2017-12-12
N207202-001	9149577	2029-12-15		Drug product	2017-12-12
N207202-001	8847766	2030-03-29	U-2167	Drug product	2017-12-12
N207202-001	8545402	2030-04-27		Drug product	2017-12-12
N207202-001	8114021	2030-06-21		Drug product	2017-12-12
N207202-001	11464423	2030-09-15		Drug product	2022-11-09
N207202-001	9941931	2030-11-04		Drug product	2018-05-07
N207202-001	8961412	2030-11-17		Drug product	2017-12-12
N207202-001	8258962	2030-11-25		Drug product	2017-12-12
N207202-001	8547248	2030-12-18	U-2167	Drug product	2017-12-12
N207202-001	11229378	2031-07-11		Drug product	2022-02-18
N207202-001	9320455	2031-12-15		Drug product	2017-12-12
N207202-001	10517507	2032-06-13		Drug product	2020-01-23
N207202-001	9268909	2033-10-15	U-2168	Drug product	2017-12-12
N207202-002	11476952	2026-04-28		Drug product	2022-11-09
N207202-002	9125939	2026-07-28	U-1749		2017-12-12
N207202-002	7978064	2026-09-14		Drug product	2017-12-12
N207202-002	8759350	2027-03-02	U-1529		2017-12-12
N207202-002	9444503	2027-11-19	U-2169	Drug product	2017-12-12
N207202-002	9119554	2028-12-16		Drug product	2017-12-12
N207202-002	9060708	2029-03-05		Drug product	2017-12-12
N207202-002	9258035	2029-03-05		Drug product	2017-12-12
N207202-002	8674825	2029-04-09	U-2170	Drug product	2017-12-12
N207202-002	8956288	2029-07-06	U-2167	Drug product	2017-12-12
N207202-002	10441194	2029-07-26		Drug product	2019-11-01
N207202-002	8945005	2029-08-19	U-2167	Drug product	2017-12-12
N207202-002	9433371	2029-09-15		Drug product	2017-12-12
N207202-002	8718193	2029-12-05		Drug product	2017-12-12
N207202-002	9149577	2029-12-15		Drug product	2017-12-12
N207202-002	8847766	2030-03-29	U-2167	Drug product	2017-12-12
N207202-002	8545402	2030-04-27		Drug product	2017-12-12
N207202-002	8114021	2030-06-21		Drug product	2017-12-12
N207202-002	11464423	2030-09-15		Drug product	2022-11-09
N207202-002	9941931	2030-11-04		Drug product	2018-05-07
N207202-002	8961412	2030-11-17		Drug product	2017-12-12
N207202-002	8258962	2030-11-25		Drug product	2017-12-12
N207202-002	8547248	2030-12-18	U-2167	Drug product	2017-12-12
N207202-002	11229378	2031-07-11		Drug product	2022-02-18
N207202-002	9320455	2031-12-15		Drug product	2017-12-12
N207202-002	10517507	2032-06-13		Drug product	2020-01-23
N207202-002	9268909	2033-10-15	U-2168	Drug product	2017-12-12
N207202-003	11476952	2026-04-28		Drug product	2022-11-09
N207202-003	9125939	2026-07-28	U-1749		2017-12-12
N207202-003	7978064	2026-09-14		Drug product	2017-12-12
N207202-003	8759350	2027-03-02	U-1529		2017-12-12
N207202-003	9444503	2027-11-19	U-2169	Drug product	2017-12-12
N207202-003	9119554	2028-12-16		Drug product	2017-12-12
N207202-003	9060708	2029-03-05		Drug product	2017-12-12
N207202-003	9258035	2029-03-05		Drug product	2017-12-12
N207202-003	8674825	2029-04-09	U-2170	Drug product	2017-12-12
N207202-003	8956288	2029-07-06	U-2167	Drug product	2017-12-12
N207202-003	10441194	2029-07-26		Drug product	2019-11-01
N207202-003	8945005	2029-08-19	U-2167	Drug product	2017-12-12
N207202-003	9433371	2029-09-15		Drug product	2017-12-12
N207202-003	8718193	2029-12-05		Drug product	2017-12-12
N207202-003	9149577	2029-12-15		Drug product	2017-12-12
N207202-003	8847766	2030-03-29	U-2167	Drug product	2017-12-12
N207202-003	8545402	2030-04-27		Drug product	2017-12-12
N207202-003	8114021	2030-06-21		Drug product	2017-12-12
N207202-003	11464423	2030-09-15		Drug product	2022-11-09
N207202-003	9941931	2030-11-04		Drug product	2018-05-07
N207202-003	8961412	2030-11-17		Drug product	2017-12-12
N207202-003	8258962	2030-11-25		Drug product	2017-12-12
N207202-003	8547248	2030-12-18	U-2167	Drug product	2017-12-12
N207202-003	11229378	2031-07-11		Drug product	2022-02-18
N207202-003	9320455	2031-12-15		Drug product	2017-12-12
N207202-003	10517507	2032-06-13		Drug product	2020-01-23

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 7 · 258 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	N207202-001	ABILIFY MYCITE KIT	2MG	TABLET / ORAL	RLD	2017-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207202-002	ABILIFY MYCITE KIT	5MG	TABLET / ORAL	RLD	2017-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207202-003	ABILIFY MYCITE KIT	10MG	TABLET / ORAL	RLD	2017-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207202-004	ABILIFY MYCITE KIT	15MG	TABLET / ORAL	RLD	2017-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207202-005	ABILIFY MYCITE KIT	20MG	TABLET / ORAL	RLD	2017-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207202-006	ABILIFY MYCITE KIT	30MG	TABLET / ORAL	RLD	2017-11-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N207202-001	ABILIFY MYCITE KIT	2MG	TABLET / ORAL	RLD	2017-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207202-002	ABILIFY MYCITE KIT	5MG	TABLET / ORAL	RLD	2017-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207202-003	ABILIFY MYCITE KIT	10MG	TABLET / ORAL	RLD	2017-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207202-004	ABILIFY MYCITE KIT	15MG	TABLET / ORAL	RLD	2017-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207202-005	ABILIFY MYCITE KIT	20MG	TABLET / ORAL	RLD	2017-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207202-006	ABILIFY MYCITE KIT	30MG	TABLET / ORAL	RLD	2017-11-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N207202-001	ABILIFY MYCITE KIT	2MG	TABLET / ORAL	RLD	2017-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207202-002	ABILIFY MYCITE KIT	5MG	TABLET / ORAL	RLD	2017-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207202-003	ABILIFY MYCITE KIT	10MG	TABLET / ORAL	RLD	2017-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207202-004	ABILIFY MYCITE KIT	15MG	TABLET / ORAL	RLD	2017-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207202-005	ABILIFY MYCITE KIT	20MG	TABLET / ORAL	RLD	2017-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207202-006	ABILIFY MYCITE KIT	30MG	TABLET / ORAL	RLD	2017-11-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207202-001	ABILIFY MYCITE KIT	2MG	TABLET / ORAL	RLD	2017-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207202-002	ABILIFY MYCITE KIT	5MG	TABLET / ORAL	RLD	2017-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207202-003	ABILIFY MYCITE KIT	10MG	TABLET / ORAL	RLD	2017-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207202-004	ABILIFY MYCITE KIT	15MG	TABLET / ORAL	RLD	2017-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207202-005	ABILIFY MYCITE KIT	20MG	TABLET / ORAL	RLD	2017-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207202-006	ABILIFY MYCITE KIT	30MG	TABLET / ORAL	RLD	2017-11-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207202-001	ABILIFY MYCITE KIT	2MG	TABLET / ORAL	RLD	2017-11-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207202-002	ABILIFY MYCITE KIT	5MG	TABLET / ORAL	RLD	2017-11-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207202-003	ABILIFY MYCITE KIT	10MG	TABLET / ORAL	RLD	2017-11-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207202-004	ABILIFY MYCITE KIT	15MG	TABLET / ORAL	RLD	2017-11-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207202-005	ABILIFY MYCITE KIT	20MG	TABLET / ORAL	RLD	2017-11-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207202-006	ABILIFY MYCITE KIT	30MG	TABLET / ORAL	RLD	2017-11-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207202-001	ABILIFY MYCITE KIT	2MG	TABLET / ORAL	RLD	2017-11-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207202-002	ABILIFY MYCITE KIT	5MG	TABLET / ORAL	RLD	2017-11-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207202-003	ABILIFY MYCITE KIT	10MG	TABLET / ORAL	RLD	2017-11-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207202-004	ABILIFY MYCITE KIT	15MG	TABLET / ORAL	RLD	2017-11-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207202-005	ABILIFY MYCITE KIT	20MG	TABLET / ORAL	RLD	2017-11-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207202-006	ABILIFY MYCITE KIT	30MG	TABLET / ORAL	RLD	2017-11-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207202-001	ABILIFY MYCITE KIT	2MG	TABLET / ORAL	RLD	2017-11-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207202-002	ABILIFY MYCITE KIT	5MG	TABLET / ORAL	RLD	2017-11-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207202-003	ABILIFY MYCITE KIT	10MG	TABLET / ORAL	RLD	2017-11-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207202-004	ABILIFY MYCITE KIT	15MG	TABLET / ORAL	RLD	2017-11-13	`b8a1b40f171c…`

Observed Orange Book patent history#

Patent history page 1 of 197 · 7,854 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	N207202-001	11476952	2026-04-28		Drug product	2022-11-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207202-001	9125939	2026-07-28	U-1749		2017-12-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207202-001	7978064	2026-09-14		Drug product	2017-12-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207202-001	8759350	2027-03-02	U-1529		2017-12-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207202-001	9444503	2027-11-19	U-2169	Drug product	2017-12-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207202-001	9119554	2028-12-16		Drug product	2017-12-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207202-001	9060708	2029-03-05		Drug product	2017-12-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207202-001	9258035	2029-03-05		Drug product	2017-12-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207202-001	8674825	2029-04-09	U-2170	Drug product	2017-12-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207202-001	8956288	2029-07-06	U-2167	Drug product	2017-12-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207202-001	10441194	2029-07-26		Drug product	2019-11-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207202-001	8945005	2029-08-19	U-2167	Drug product	2017-12-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207202-001	9433371	2029-09-15		Drug product	2017-12-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207202-001	8718193	2029-12-05		Drug product	2017-12-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207202-001	9149577	2029-12-15		Drug product	2017-12-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207202-001	8847766	2030-03-29	U-2167	Drug product	2017-12-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207202-001	8545402	2030-04-27		Drug product	2017-12-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207202-001	8114021	2030-06-21		Drug product	2017-12-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207202-001	11464423	2030-09-15		Drug product	2022-11-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207202-001	9941931	2030-11-04		Drug product	2018-05-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207202-001	8961412	2030-11-17		Drug product	2017-12-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207202-001	8258962	2030-11-25		Drug product	2017-12-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207202-001	8547248	2030-12-18	U-2167	Drug product	2017-12-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207202-001	11229378	2031-07-11		Drug product	2022-02-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207202-001	9320455	2031-12-15		Drug product	2017-12-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207202-001	10517507	2032-06-13		Drug product	2020-01-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207202-001	9268909	2033-10-15	U-2168	Drug product	2017-12-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207202-002	11476952	2026-04-28		Drug product	2022-11-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207202-002	9125939	2026-07-28	U-1749		2017-12-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207202-002	7978064	2026-09-14		Drug product	2017-12-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207202-002	8759350	2027-03-02	U-1529		2017-12-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207202-002	9444503	2027-11-19	U-2169	Drug product	2017-12-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207202-002	9119554	2028-12-16		Drug product	2017-12-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207202-002	9060708	2029-03-05		Drug product	2017-12-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207202-002	9258035	2029-03-05		Drug product	2017-12-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207202-002	8674825	2029-04-09	U-2170	Drug product	2017-12-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207202-002	8956288	2029-07-06	U-2167	Drug product	2017-12-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207202-002	10441194	2029-07-26		Drug product	2019-11-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207202-002	8945005	2029-08-19	U-2167	Drug product	2017-12-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N207202-002	9433371	2029-09-15		Drug product	2017-12-12	`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	N207202-001	I-746	2020-07-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207202-002	I-746	2020-07-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207202-003	I-746	2020-07-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207202-004	I-746	2020-07-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207202-005	I-746	2020-07-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207202-006	I-746	2020-07-27	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N207202-001	I-746	2020-07-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N207202-002	I-746	2020-07-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N207202-003	I-746	2020-07-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N207202-004	I-746	2020-07-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N207202-005	I-746	2020-07-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N207202-006	I-746	2020-07-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N207202-001	I-746	2020-07-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N207202-002	I-746	2020-07-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N207202-003	I-746	2020-07-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N207202-004	I-746	2020-07-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N207202-005	I-746	2020-07-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N207202-006	I-746	2020-07-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N207202-001	I-746	2020-07-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N207202-002	I-746	2020-07-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N207202-003	I-746	2020-07-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N207202-004	I-746	2020-07-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N207202-005	I-746	2020-07-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N207202-006	I-746	2020-07-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N207202-001	I-746	2020-07-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N207202-002	I-746	2020-07-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N207202-003	I-746	2020-07-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N207202-004	I-746	2020-07-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N207202-005	I-746	2020-07-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N207202-006	I-746	2020-07-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N207202-001	I-746	2020-07-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N207202-002	I-746	2020-07-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N207202-003	I-746	2020-07-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N207202-004	I-746	2020-07-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N207202-005	I-746	2020-07-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N207202-006	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 2 of 6 · 116 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	9b695d4b-3794-4b89-8575-6feb83697ccc	2026-05-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	c092a736-16e2-4dd0-8769-cb766a62f4d9	2026-05-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Coupler LLC	512874e6-6d00-2623-e063-6394a90aa4bc	2026-05-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Coupler LLC	50214c47-2ea3-b373-e063-6394a90aad23	2026-04-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	6f580e75-61ab-4c7b-bb3f-f027a9603f84	2026-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
ABILIFY MAINTENA	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6	2026-03-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	433cdc7d-465a-4ad4-bd84-cabd37e15f51	2026-03-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
aripiprazole	ARIPIPRAZOLE	Major Pharmaceuticals	969c17aa-6abc-413c-8561-f1ad8fdde3e5	2026-03-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Preferred Pharmaceuticals, Inc.	36fb0c13-dfae-46ac-bb71-0b53fe5649f4	2026-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Preferred Pharmaceuticals Inc.	02a4af27-c83c-4166-950c-7a1cb12d198d	2026-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	ff8dc838-ca1a-49d3-8938-5ae645574a75	2026-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	2bc00231-c2e7-4b9d-93a1-fb796fd8d591	2026-02-11	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	1e8d889e-126b-4627-a2cc-34f2d35a5d67	2026-01-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	1ef9e44f-5672-47c2-97e9-286e1b84417d	2026-01-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	4bda6f17-d87c-4009-b329-99275c56106f	2026-01-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	fb40b669-4e37-4087-8fb1-3ac140543602	2026-01-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	A-S Medication Solutions	554db933-aa80-4685-bcd5-58c84571c19c	2026-01-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Coupler LLC	47430dfa-9377-6c31-e063-6394a90a86a9	2025-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
ARIPIPRAZOLE	ARIPIPRAZOLE	QUAGEN PHARMACEUTICALS LLC	b12f1ff2-c0b5-47e7-8075-bf2ce79fdaf8	2025-12-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Quallent Pharmaceuticals Health LLC	0e0d42ad-f4c6-4e30-adc2-ab1d122428ec	2025-12-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE

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 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59148-029	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-029	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceut	NDA	Current
59148-029	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-029	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-029	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-029	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-029	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-030	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-030	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceut	NDA	Current
59148-030	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-030	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-030	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-030	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-030	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-031	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-031	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceut	NDA	Current
59148-031	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-031	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-031	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-031	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-031	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-032	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-032	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceut	NDA	Current
59148-032	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-032	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-032	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-032	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-032	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-033	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-033	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceut	NDA	Current
59148-033	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-033	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-033	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-033	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-033	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-034	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-034	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceut	NDA	Current
59148-034	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-034	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-034	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-034	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-034	Abilify MyCite	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81138	SUPPL	2025-02-07
81020	SUPPL	2025-02-05
81019	SUPPL	2025-02-05
72782	SUPPL	2022-12-05
72781	SUPPL	2022-12-05
72757	SUPPL	2022-12-01
65741	SUPPL	2020-12-28
65740	SUPPL	2020-12-28
61815	SUPPL	2020-02-06
61813	SUPPL	2020-02-06
61812	SUPPL	2020-02-06
61811	SUPPL	2020-02-06
61795	SUPPL	2020-02-06
61794	SUPPL	2020-02-06
55134	ORIG	2018-08-08
50415	ORIG	2017-11-15
50398	ORIG	2017-11-13