Application 021729

Type: NDA
Sponsor: OTSUKA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
002	ABILIFY	ARIPIPRAZOLE	TABLET, ORALLY DISINTEGRATING;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	ABILIFY	ARIPIPRAZOLE	TABLET, ORALLY DISINTEGRATING;ORAL	15MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	ABILIFY	ARIPIPRAZOLE	TABLET, ORALLY DISINTEGRATING;ORAL	20MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
005	ABILIFY	ARIPIPRAZOLE	TABLET, ORALLY DISINTEGRATING;ORAL	30MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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
N021729-002	ABILIFY	ARIPIPRAZOLE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-07
N021729-003	ABILIFY	ARIPIPRAZOLE	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-07
N021729-004	ABILIFY	ARIPIPRAZOLE	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-07
N021729-005	ABILIFY	ARIPIPRAZOLE	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-07

Orange Book patents#

Current patent rows page 1 of 1 · 4 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N021729-002	9125939	2026-07-28	U-1749	2015-10-07
N021729-002	8759350	2027-03-02	U-1529	2014-07-22
N021729-003	9125939	2026-07-28	U-1749	2015-10-07
N021729-003	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 5 · 172 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	N021729-002	ABILIFY	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021729-003	ABILIFY	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021729-004	ABILIFY	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021729-005	ABILIFY	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021729-002	ABILIFY	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021729-003	ABILIFY	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021729-004	ABILIFY	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021729-005	ABILIFY	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021729-002	ABILIFY	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021729-003	ABILIFY	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021729-004	ABILIFY	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021729-005	ABILIFY	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021729-002	ABILIFY	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021729-003	ABILIFY	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021729-004	ABILIFY	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021729-005	ABILIFY	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021729-002	ABILIFY	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021729-003	ABILIFY	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021729-004	ABILIFY	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021729-005	ABILIFY	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021729-002	ABILIFY	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021729-003	ABILIFY	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021729-004	ABILIFY	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021729-005	ABILIFY	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021729-002	ABILIFY	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021729-003	ABILIFY	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021729-004	ABILIFY	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021729-005	ABILIFY	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021729-002	ABILIFY	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021729-003	ABILIFY	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021729-004	ABILIFY	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021729-005	ABILIFY	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021729-002	ABILIFY	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021729-003	ABILIFY	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021729-004	ABILIFY	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021729-005	ABILIFY	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021729-002	ABILIFY	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021729-003	ABILIFY	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021729-004	ABILIFY	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021729-005	ABILIFY	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL	RLD	2006-06-07	`5bbf6a4d5a75…`

Observed Orange Book patent history#

Patent history page 1 of 33 · 1,304 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	N021729-002	9125939	2026-07-28	U-1749		2015-10-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021729-002	8759350	2027-03-02	U-1529		2014-07-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021729-003	9125939	2026-07-28	U-1749		2015-10-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021729-003	8759350	2027-03-02	U-1529		2014-07-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021729-002	9125939	2026-07-28	U-1749		2015-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021729-002	8759350	2027-03-02	U-1529		2014-07-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021729-003	9125939	2026-07-28	U-1749		2015-10-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021729-003	8759350	2027-03-02	U-1529		2014-07-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021729-002	9125939	2026-07-28	U-1749		2015-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021729-002	8759350	2027-03-02	U-1529		2014-07-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021729-003	9125939	2026-07-28	U-1749		2015-10-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021729-003	8759350	2027-03-02	U-1529		2014-07-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021729-002	9125939	2026-07-28	U-1749		2015-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021729-002	8759350	2027-03-02	U-1529		2014-07-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021729-003	9125939	2026-07-28	U-1749		2015-10-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021729-003	8759350	2027-03-02	U-1529		2014-07-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021729-002	9125939	2026-07-28	U-1749		2015-10-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021729-002	8759350	2027-03-02	U-1529		2014-07-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021729-003	9125939	2026-07-28	U-1749		2015-10-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021729-003	8759350	2027-03-02	U-1529		2014-07-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021729-002	9125939	2026-07-28	U-1749		2015-10-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021729-002	8759350	2027-03-02	U-1529		2014-07-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021729-003	9125939	2026-07-28	U-1749		2015-10-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021729-003	8759350	2027-03-02	U-1529		2014-07-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021729-002	9125939	2026-07-28	U-1749		2015-10-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021729-002	8759350	2027-03-02	U-1529		2014-07-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021729-003	9125939	2026-07-28	U-1749		2015-10-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021729-003	8759350	2027-03-02	U-1529		2014-07-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021729-002	8017615	2024-06-16		Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021729-002	8017615*PED	2024-12-16		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021729-002	9125939	2026-07-28	U-1749		2015-10-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021729-002	8759350	2027-03-02	U-1529		2014-07-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021729-003	8017615	2024-06-16		Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021729-003	8017615*PED	2024-12-16		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021729-003	9125939	2026-07-28	U-1749		2015-10-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021729-003	8759350	2027-03-02	U-1529		2014-07-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021729-004	8017615	2024-06-16		Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021729-004	8017615*PED	2024-12-16		Pediatric extension		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021729-005	8017615	2024-06-16		Drug product		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021729-005	8017615*PED	2024-12-16		Pediatric extension		`03ed91905a0d…`

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	N021729-002	ODE-80	2021-12-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021729-003	ODE-80	2021-12-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021729-004	ODE-80	2021-12-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021729-005	ODE-80	2021-12-12	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021729-002	ODE-80	2021-12-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021729-003	ODE-80	2021-12-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021729-004	ODE-80	2021-12-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021729-005	ODE-80	2021-12-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021729-002	ODE-80	2021-12-12	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021729-003	ODE-80	2021-12-12	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021729-004	ODE-80	2021-12-12	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021729-005	ODE-80	2021-12-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021729-002	ODE-80	2021-12-12	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021729-003	ODE-80	2021-12-12	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021729-004	ODE-80	2021-12-12	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021729-005	ODE-80	2021-12-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021729-002	ODE-80	2021-12-12	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021729-003	ODE-80	2021-12-12	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021729-004	ODE-80	2021-12-12	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021729-005	ODE-80	2021-12-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021729-002	ODE-80	2021-12-12	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021729-003	ODE-80	2021-12-12	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021729-004	ODE-80	2021-12-12	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021729-005	ODE-80	2021-12-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021729-002	ODE-80	2021-12-12	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021729-003	ODE-80	2021-12-12	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021729-004	ODE-80	2021-12-12	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021729-005	ODE-80	2021-12-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021729-002	ODE-80	2021-12-12	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021729-003	ODE-80	2021-12-12	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021729-004	ODE-80	2021-12-12	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021729-005	ODE-80	2021-12-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021729-002	ODE-80	2021-12-12	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021729-003	ODE-80	2021-12-12	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021729-004	ODE-80	2021-12-12	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021729-005	ODE-80	2021-12-12	`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 6 of 6 · 116 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aripiprazole	ARIPIPRAZOLE	NorthStar RxLLC	f87dbfe4-5417-47c9-a97f-d246cfc10023	2023-08-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	SQUARE PHARMACEUTICALS LIMITED	0f9b1fd8-a648-45c9-8655-14de07439f34	2023-07-02		Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	XLCare Pharmaceuticals, Inc.	0a6fa113-6bb2-4f88-af07-ce0914c98ff2	2023-06-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	ScieGen Pharmaceuticals Inc	a7d9d5d1-25ba-4f4e-a990-398c0bf09c7e	2023-02-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Alembic Pharmaceuticals Limited	4f1691a8-724e-430d-9bab-27b59ef9bd4e	2023-01-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Alembic Pharmaceuticals Limited	793fc904-2f11-4f97-a0ac-4d6910cac0f9	2023-01-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	XLCare Pharmaceuticals, Inc.	b284b294-40a0-4ccd-b7b7-b61267cd4e76	2023-01-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
ARIPIPRAZOLE	ARIPIPRAZOLE	A-S Medication Solutions	aaf7dc7e-04f3-442b-86d7-5f54d17d102c	2022-09-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	NCS HealthCare of KY, LLC dba Vangard Labs	8da99c93-613e-4b78-9f91-3efc2dea194d	2022-08-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Proficient Rx LP	19a3c2f2-11eb-4ec9-ac38-134168bdf99c	2022-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Proficient Rx LP	11202c0a-7401-41c9-b1e7-d93739fcd36f	2022-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Dr.Reddys Laboratories Inc	0aa7e178-456a-4942-93aa-9ec18a58939f	2020-06-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	ScieGen Pharmaceuticals Inc	95954ba3-e838-4dd7-aef1-c51ac6aff76b	2020-05-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Proficient Rx LP	dbdc8fbe-c75f-4f17-a2cd-9f23802dcc5d	2019-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Exelan Pharmaceuticals, Inc.	705190bf-9f9d-4183-a56b-4eeafeacde59	2018-12-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
ARIPIPRAZOLE	ARIPIPRAZOLE	Camber Pharmaceuticals, Inc.	3718e585-06b9-40fd-a3eb-18b6497a4235	2017-08-08	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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59148-640	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-640	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-640	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-641	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-641	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-641	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
61827	SUPPL	2020-02-06
61826	SUPPL	2020-02-06
61825	SUPPL	2020-02-06
61824	SUPPL	2020-02-06
61799	SUPPL	2020-02-06
61798	SUPPL	2020-02-06
59638	SUPPL	2019-08-08
59637	SUPPL	2019-08-08
59624	SUPPL	2019-08-08
47426	SUPPL	2017-03-02
47328	SUPPL	2017-02-24
45102	SUPPL	2016-08-23
45147	SUPPL	2016-08-18
37545	SUPPL	2016-01-22
6071	SUPPL	2016-01-20
28483	SUPPL	2014-12-15
16271	SUPPL	2014-12-15
6069	SUPPL	2014-07-11
37543	SUPPL	2014-06-10
37544	SUPPL	2013-08-09
6070	SUPPL	2013-08-05
6068	SUPPL	2012-02-27
16270	SUPPL	2012-02-24
42289	SUPPL	2012-01-27
42288	SUPPL	2012-01-27
21794	SUPPL	2012-01-27
23673	ORIG	2011-12-22
6067	SUPPL	2011-03-08
16269	SUPPL	2011-03-07
16268	SUPPL	2011-02-24
28481	SUPPL	2011-02-18
6066	SUPPL	2010-12-07
37542	SUPPL	2010-12-03
28482	SUPPL	2010-12-03
37541	SUPPL	2010-12-02
28480	SUPPL	2009-07-24
16267	SUPPL	2009-07-23
37540	SUPPL	2008-08-26
28479	SUPPL	2008-08-19
44645	SUPPL	2008-07-17
24214	SUPPL	2008-07-17
24213	SUPPL	2008-07-17
28478	SUPPL	2008-05-14
28476	SUPPL	2008-05-14
6064	SUPPL	2008-05-14
6065	SUPPL	2008-03-07
28477	SUPPL	2008-02-29
37539	SUPPL	2008-02-28
37538	SUPPL	2007-11-19
6063	SUPPL	2007-11-19
6062	SUPPL	2007-11-08
16266	SUPPL	2007-11-07
6061	SUPPL	2007-10-04
37537	SUPPL	2007-09-26
42287	ORIG	2007-08-31
37536	SUPPL	2006-10-23
28475	SUPPL	2006-10-23
28474	ORIG	2006-06-12
37535	ORIG	2006-06-08
51607	SUPPL	1900-01-01