Application 021436

Type: NDA
Sponsor: OTSUKA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ABILIFY	ARIPIPRAZOLE	TABLET;ORAL	10MG	Yes	Yes
002	ABILIFY	ARIPIPRAZOLE	TABLET;ORAL	15MG	Yes	No
003	ABILIFY	ARIPIPRAZOLE	TABLET;ORAL	20MG	Yes	No
004	ABILIFY	ARIPIPRAZOLE	TABLET;ORAL	30MG	Yes	No
005	ABILIFY	ARIPIPRAZOLE	TABLET;ORAL	5MG	Yes	Yes
006	ABILIFY	ARIPIPRAZOLE	TABLET;ORAL	2MG	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	TE codes	RLD / RS	Approval date
N021436-001	ABILIFY	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	RLD, RS	2002-11-15
N021436-002	ABILIFY	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	RLD	2002-11-15
N021436-003	ABILIFY	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	RLD	2002-11-15
N021436-004	ABILIFY	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	RLD	2002-11-15
N021436-005	ABILIFY	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	RLD	2002-11-15
N021436-006	ABILIFY	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	RLD	2002-11-15

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
N021436-001	AB
N021436-002	AB
N021436-003	AB
N021436-004	AB
N021436-005	AB
N021436-006	AB

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N021436-001	9125939	2026-07-28	U-1749	2015-10-07
N021436-001	8759350	2027-03-02	U-1529	2014-07-22
N021436-002	9125939	2026-07-28	U-1749	2015-10-07
N021436-002	8759350	2027-03-02	U-1529	2014-07-22
N021436-003	9125939	2026-07-28	U-1749	2015-10-07
N021436-003	8759350	2027-03-02	U-1529	2014-07-22
N021436-004	9125939	2026-07-28	U-1749	2015-10-07
N021436-004	8759350	2027-03-02	U-1529	2014-07-22
N021436-005	9125939	2026-07-28	U-1749	2015-10-07
N021436-005	8759350	2027-03-02	U-1529	2014-07-22
N021436-006	9125939	2026-07-28	U-1749	2015-10-07
N021436-006	8759350	2027-03-02	U-1529	2014-07-22

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021436-001	ABILIFY	10MG	TABLET / ORAL	AB	RLD, RS	2002-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021436-002	ABILIFY	15MG	TABLET / ORAL	AB	RLD	2002-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021436-003	ABILIFY	20MG	TABLET / ORAL	AB	RLD	2002-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021436-004	ABILIFY	30MG	TABLET / ORAL	AB	RLD	2002-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021436-005	ABILIFY	5MG	TABLET / ORAL	AB	RLD	2002-11-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021436-006	ABILIFY	2MG	TABLET / ORAL	AB	RLD	2002-11-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021436-001	ABILIFY	10MG	TABLET / ORAL	AB	RLD, RS	2002-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021436-002	ABILIFY	15MG	TABLET / ORAL	AB	RLD	2002-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021436-003	ABILIFY	20MG	TABLET / ORAL	AB	RLD	2002-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021436-004	ABILIFY	30MG	TABLET / ORAL	AB	RLD	2002-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021436-005	ABILIFY	5MG	TABLET / ORAL	AB	RLD	2002-11-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021436-006	ABILIFY	2MG	TABLET / ORAL	AB	RLD	2002-11-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021436-001	ABILIFY	10MG	TABLET / ORAL	AB	RLD, RS	2002-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021436-002	ABILIFY	15MG	TABLET / ORAL	AB	RLD	2002-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021436-003	ABILIFY	20MG	TABLET / ORAL	AB	RLD	2002-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021436-004	ABILIFY	30MG	TABLET / ORAL	AB	RLD	2002-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021436-005	ABILIFY	5MG	TABLET / ORAL	AB	RLD	2002-11-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021436-006	ABILIFY	2MG	TABLET / ORAL	AB	RLD	2002-11-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021436-001	ABILIFY	10MG	TABLET / ORAL	AB	RLD, RS	2002-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021436-002	ABILIFY	15MG	TABLET / ORAL	AB	RLD	2002-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021436-003	ABILIFY	20MG	TABLET / ORAL	AB	RLD	2002-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021436-004	ABILIFY	30MG	TABLET / ORAL	AB	RLD	2002-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021436-005	ABILIFY	5MG	TABLET / ORAL	AB	RLD	2002-11-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021436-006	ABILIFY	2MG	TABLET / ORAL	AB	RLD	2002-11-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021436-001	ABILIFY	10MG	TABLET / ORAL	AB	RLD, RS	2002-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021436-002	ABILIFY	15MG	TABLET / ORAL	AB	RLD	2002-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021436-003	ABILIFY	20MG	TABLET / ORAL	AB	RLD	2002-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021436-004	ABILIFY	30MG	TABLET / ORAL	AB	RLD	2002-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021436-005	ABILIFY	5MG	TABLET / ORAL	AB	RLD	2002-11-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021436-006	ABILIFY	2MG	TABLET / ORAL	AB	RLD	2002-11-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021436-001	ABILIFY	10MG	TABLET / ORAL	AB	RLD, RS	2002-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021436-002	ABILIFY	15MG	TABLET / ORAL	AB	RLD	2002-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021436-003	ABILIFY	20MG	TABLET / ORAL	AB	RLD	2002-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021436-004	ABILIFY	30MG	TABLET / ORAL	AB	RLD	2002-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021436-005	ABILIFY	5MG	TABLET / ORAL	AB	RLD	2002-11-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021436-006	ABILIFY	2MG	TABLET / ORAL	AB	RLD	2002-11-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021436-001	ABILIFY	10MG	TABLET / ORAL	AB	RLD, RS	2002-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021436-002	ABILIFY	15MG	TABLET / ORAL	AB	RLD	2002-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021436-003	ABILIFY	20MG	TABLET / ORAL	AB	RLD	2002-11-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021436-004	ABILIFY	30MG	TABLET / ORAL	AB	RLD	2002-11-15	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N021436-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021436-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021436-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021436-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021436-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021436-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021436-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021436-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021436-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021436-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021436-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021436-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021436-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021436-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021436-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021436-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021436-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021436-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021436-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021436-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021436-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021436-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021436-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021436-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021436-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021436-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021436-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021436-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021436-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021436-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021436-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021436-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021436-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021436-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021436-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021436-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021436-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021436-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021436-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021436-004	AB	1	`b8a1b40f171c…`

Observed Orange Book patent history#

Patent history page 1 of 54 · 2,124 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021436-001	9125939	2026-07-28	U-1749	2015-10-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021436-001	8759350	2027-03-02	U-1529	2014-07-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021436-002	9125939	2026-07-28	U-1749	2015-10-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021436-002	8759350	2027-03-02	U-1529	2014-07-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021436-003	9125939	2026-07-28	U-1749	2015-10-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021436-003	8759350	2027-03-02	U-1529	2014-07-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021436-004	9125939	2026-07-28	U-1749	2015-10-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021436-004	8759350	2027-03-02	U-1529	2014-07-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021436-005	9125939	2026-07-28	U-1749	2015-10-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021436-005	8759350	2027-03-02	U-1529	2014-07-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021436-006	9125939	2026-07-28	U-1749	2015-10-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021436-006	8759350	2027-03-02	U-1529	2014-07-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021436-001	9125939	2026-07-28	U-1749	2015-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021436-001	8759350	2027-03-02	U-1529	2014-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021436-002	9125939	2026-07-28	U-1749	2015-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021436-002	8759350	2027-03-02	U-1529	2014-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021436-003	9125939	2026-07-28	U-1749	2015-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021436-003	8759350	2027-03-02	U-1529	2014-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021436-004	9125939	2026-07-28	U-1749	2015-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021436-004	8759350	2027-03-02	U-1529	2014-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021436-005	9125939	2026-07-28	U-1749	2015-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021436-005	8759350	2027-03-02	U-1529	2014-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021436-006	9125939	2026-07-28	U-1749	2015-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021436-006	8759350	2027-03-02	U-1529	2014-07-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021436-001	9125939	2026-07-28	U-1749	2015-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021436-001	8759350	2027-03-02	U-1529	2014-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021436-002	9125939	2026-07-28	U-1749	2015-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021436-002	8759350	2027-03-02	U-1529	2014-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021436-003	9125939	2026-07-28	U-1749	2015-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021436-003	8759350	2027-03-02	U-1529	2014-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021436-004	9125939	2026-07-28	U-1749	2015-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021436-004	8759350	2027-03-02	U-1529	2014-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021436-005	9125939	2026-07-28	U-1749	2015-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021436-005	8759350	2027-03-02	U-1529	2014-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021436-006	9125939	2026-07-28	U-1749	2015-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021436-006	8759350	2027-03-02	U-1529	2014-07-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021436-001	9125939	2026-07-28	U-1749	2015-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021436-001	8759350	2027-03-02	U-1529	2014-07-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021436-002	9125939	2026-07-28	U-1749	2015-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021436-002	8759350	2027-03-02	U-1529	2014-07-22	`31067a03dcf5…`

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
2019-12-13 00:20 UTC	2019-12	N021436-001	ODE-80	2021-12-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021436-002	ODE-80	2021-12-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021436-003	ODE-80	2021-12-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021436-004	ODE-80	2021-12-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021436-005	ODE-80	2021-12-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021436-006	ODE-80	2021-12-12	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021436-001	ODE-80	2021-12-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021436-002	ODE-80	2021-12-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021436-003	ODE-80	2021-12-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021436-004	ODE-80	2021-12-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021436-005	ODE-80	2021-12-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021436-006	ODE-80	2021-12-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021436-001	ODE-80	2021-12-12	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021436-002	ODE-80	2021-12-12	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021436-003	ODE-80	2021-12-12	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021436-004	ODE-80	2021-12-12	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021436-005	ODE-80	2021-12-12	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021436-006	ODE-80	2021-12-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021436-001	ODE-80	2021-12-12	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021436-002	ODE-80	2021-12-12	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021436-003	ODE-80	2021-12-12	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021436-004	ODE-80	2021-12-12	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021436-005	ODE-80	2021-12-12	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021436-006	ODE-80	2021-12-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021436-001	ODE-80	2021-12-12	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021436-002	ODE-80	2021-12-12	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021436-003	ODE-80	2021-12-12	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021436-004	ODE-80	2021-12-12	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021436-005	ODE-80	2021-12-12	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021436-006	ODE-80	2021-12-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021436-001	ODE-80	2021-12-12	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021436-002	ODE-80	2021-12-12	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021436-003	ODE-80	2021-12-12	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021436-004	ODE-80	2021-12-12	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021436-005	ODE-80	2021-12-12	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021436-006	ODE-80	2021-12-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021436-001	ODE-80	2021-12-12	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021436-002	ODE-80	2021-12-12	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021436-003	ODE-80	2021-12-12	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021436-004	ODE-80	2021-12-12	`3f01610625f2…`

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	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	c040bd1d-45b7-49f2-93ea-aed7220b30ac	2025-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021436 application number: NDA021436 ndc (product): 59148-008 ndc (product): 59148-007 ndc (product): 59148-006 ndc (product): 59148-011 ndc (product): 59148-009 ndc (product): 59148-010

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 · 71 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-002	ABILIFY	ARIPIPRAZOLE	Rebel Distributors Corp.	NDA	Current
21695-003	ABILIFY	ARIPIPRAZOLE	Rebel Distributors Corp.	NDA	Current
21695-004	ABILIFY	ARIPIPRAZOLE	Rebel Distributors Corp.	NDA	Current
21695-005	ABILIFY	ARIPIPRAZOLE	Rebel Distributors Corp.	NDA	Current
43353-848	ABILIFY	ARIPIPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
43353-849	ABILIFY	ARIPIPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
43353-850	ABILIFY	ARIPIPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	NDA	Current
52959-604	ABILIFY	ARIPIPRAZOLE	H.J. Harkins Company, Inc.	NDA	Current
55289-251	ABILIFY	ARIPIPRAZOLE	PD-Rx Pharmaceuticals, In	NDA	Current
55289-251	ABILIFY	ARIPIPRAZOLE	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-251	ABILIFY	ARIPIPRAZOLE	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-251	ABILIFY	ARIPIPRAZOLE	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-251	ABILIFY	ARIPIPRAZOLE	PD-Rx Pharmaceuticals, Inc.	NDA	Current
55289-251	ABILIFY	ARIPIPRAZOLE	PD-Rx Pharmaceuticals, Inc.	NDA	Current
59148-006	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-006	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-006	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-006	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-006	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-006	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-006	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-006	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-007	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-007	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-007	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-007	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-007	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-007	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-007	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-007	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-008	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-008	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-008	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-008	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-008	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-008	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-008	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-008	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-009	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-009	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-009	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-009	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-009	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-009	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-009	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-009	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-010	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-010	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-010	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-010	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-010	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-010	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-010	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-010	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-011	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-011	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-011	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-011	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-011	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-011	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-011	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-011	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
63629-3387	ABILIFY	ARIPIPRAZOLE	Bryant Ranch Prepack	NDA	Current
63629-3387	ABILIFY	ARIPIPRAZOLE	Bryant Ranch Prepack	NDA	Current
64725-0006	ABILIFY	ARIPIPRAZOLE	TYA Pharmaceuticals	NDA	Current
64725-0007	ABILIFY	ARIPIPRAZOLE	TYA Pharmaceuticals	NDA	Current
64725-0009	ABILIFY	ARIPIPRAZOLE	TYA Pharmaceuticals	NDA	Current
64725-8000	ABILIFY	ARIPIPRAZOLE	TYA Pharmaceuticals	NDA	Current
68151-4461	ABILIFY	ARIPIPRAZOLE	Carilion Materials Management	NDA	Current
68151-4982	ABILIFY	ARIPIPRAZOLE	Carilion Materials Management	NDA	Current
68151-5121	ABILIFY	ARIPIPRAZOLE	Carilion Materials Management	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81133	SUPPL	2025-02-07
81132	SUPPL	2025-02-07
81025	SUPPL	2025-02-05
81024	SUPPL	2025-02-05
81023	SUPPL	2025-02-05
72780	SUPPL	2022-12-05
72779	SUPPL	2022-12-05
72756	SUPPL	2022-12-01
61819	SUPPL	2020-02-06
61818	SUPPL	2020-02-06
61817	SUPPL	2020-02-06
61816	SUPPL	2020-02-06
61792	SUPPL	2020-02-06
61791	SUPPL	2020-02-06
59634	SUPPL	2019-08-08
59633	SUPPL	2019-08-08
59622	SUPPL	2019-08-08
47424	SUPPL	2017-03-02
47330	SUPPL	2017-02-24
45787	SUPPL	2016-11-02
45238	SUPPL	2016-08-18
45086	SUPPL	2016-08-18
21657	SUPPL	2016-07-28
21656	SUPPL	2016-04-20
15466	SUPPL	2016-01-22
27780	SUPPL	2016-01-20
36925	SUPPL	2014-12-15
27779	SUPPL	2014-12-15
27777	SUPPL	2014-07-11
42164	SUPPL	2014-06-16
15464	SUPPL	2014-06-10
15465	SUPPL	2013-08-09
21654	SUPPL	2013-08-06
27778	SUPPL	2013-08-05
21653	SUPPL	2013-05-10
42160	SUPPL	2012-03-14
27776	SUPPL	2012-02-27
36924	SUPPL	2012-02-24
42163	SUPPL	2012-01-27
42162	SUPPL	2012-01-27
42161	SUPPL	2012-01-27
44122	ORIG	2011-12-22
5371	SUPPL	2011-03-08
15463	SUPPL	2011-03-07
36921	SUPPL	2011-02-24
5369	SUPPL	2011-02-18
5370	SUPPL	2010-12-07
36923	SUPPL	2010-12-03
27775	SUPPL	2010-12-03
36922	SUPPL	2010-12-02
5368	SUPPL	2009-11-27
15462	SUPPL	2009-11-23
24197	SUPPL	2009-08-20
21655	SUPPL	2009-08-20
27774	SUPPL	2009-07-24
36920	SUPPL	2009-07-23
15461	SUPPL	2008-08-26
5367	SUPPL	2008-08-19
24200	SUPPL	2008-07-17
24199	SUPPL	2008-07-17
24198	SUPPL	2008-07-17
27773	SUPPL	2008-05-14
27772	SUPPL	2008-05-14
5364	SUPPL	2008-05-14
5366	SUPPL	2008-03-07
5365	SUPPL	2008-02-29
15460	SUPPL	2008-02-28
27771	SUPPL	2007-11-19
15459	SUPPL	2007-11-19
27770	SUPPL	2007-11-08
36919	SUPPL	2007-11-07
5363	SUPPL	2007-10-04
36918	SUPPL	2007-09-26
42159	SUPPL	2007-09-24
21652	SUPPL	2007-09-24
36916	SUPPL	2006-10-23
27769	SUPPL	2006-10-23
36917	SUPPL	2006-09-20
5362	SUPPL	2006-09-20
36915	SUPPL	2006-02-22
27768	SUPPL	2006-02-22
36914	SUPPL	2005-06-23
27766	SUPPL	2005-06-23
27767	SUPPL	2005-03-03
27765	SUPPL	2005-03-03
15458	SUPPL	2005-03-03
15456	SUPPL	2005-03-03
27764	SUPPL	2004-10-04
15455	SUPPL	2004-10-04
15457	SUPPL	2004-05-03
5361	SUPPL	2004-04-20
15454	SUPPL	2003-09-09
5360	SUPPL	2003-09-09
42158	ORIG	2003-03-07
51237	SUPPL	2003-02-11
51236	SUPPL	2003-02-11
36913	ORIG	2002-11-15
27763	ORIG	2002-11-15
63504	ORIG	1900-01-01
63502	SUPPL	1900-01-01