Application 021713

Type: NDA
Sponsor: OTSUKA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ABILIFY	ARIPIPRAZOLE	SOLUTION;ORAL	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021713-001	ABILIFY	ARIPIPRAZOLE	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2004-12-10

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N021713-001	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 2 · 43 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	N021713-001	ABILIFY	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2004-12-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021713-001	ABILIFY	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2004-12-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021713-001	ABILIFY	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2004-12-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021713-001	ABILIFY	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2004-12-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021713-001	ABILIFY	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2004-12-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021713-001	ABILIFY	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2004-12-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021713-001	ABILIFY	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2004-12-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021713-001	ABILIFY	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2004-12-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021713-001	ABILIFY	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2004-12-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021713-001	ABILIFY	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2004-12-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021713-001	ABILIFY	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2004-12-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021713-001	ABILIFY	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2004-12-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021713-001	ABILIFY	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2004-12-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021713-001	ABILIFY	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2004-12-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021713-001	ABILIFY	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2004-12-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021713-001	ABILIFY	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2004-12-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021713-001	ABILIFY	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2004-12-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021713-001	ABILIFY	1MG/ML	SOLUTION / ORAL	RLD	2004-12-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021713-001	ABILIFY	1MG/ML	SOLUTION / ORAL	RLD	2004-12-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021713-001	ABILIFY	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL	RLD	2004-12-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021713-001	ABILIFY	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2004-12-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021713-001	ABILIFY	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL	RLD	2004-12-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021713-001	ABILIFY	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL	RLD	2004-12-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021713-001	ABILIFY	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL	RLD	2004-12-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021713-001	ABILIFY	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL	RLD	2004-12-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021713-001	ABILIFY	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL	RLD	2004-12-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021713-001	ABILIFY	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL	RLD	2004-12-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021713-001	ABILIFY	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL	RLD	2004-12-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021713-001	ABILIFY	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION / ORAL	RLD	2004-12-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021713-001	ABILIFY	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2004-12-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021713-001	ABILIFY	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2004-12-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021713-001	ABILIFY	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2004-12-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021713-001	ABILIFY	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2004-12-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021713-001	ABILIFY	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2004-12-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021713-001	ABILIFY	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2004-12-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021713-001	ABILIFY	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2004-12-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021713-001	ABILIFY	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2004-12-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021713-001	ABILIFY	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2004-12-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021713-001	ABILIFY	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2004-12-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021713-001	ABILIFY	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2004-12-10	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 157 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	N021713-001	8759350	2027-03-02	U-1529		2014-07-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021713-001	8759350	2027-03-02	U-1529		2014-07-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021713-001	8759350	2027-03-02	U-1529		2014-07-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021713-001	8759350	2027-03-02	U-1529		2014-07-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021713-001	8759350	2027-03-02	U-1529		2014-07-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021713-001	8759350	2027-03-02	U-1529		2014-07-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021713-001	8759350	2027-03-02	U-1529		2014-07-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021713-001	8759350	2027-03-02	U-1529		2014-07-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021713-001	8759350	2027-03-02	U-1529		2014-07-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021713-001	8759350	2027-03-02	U-1529		2014-07-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021713-001	8759350	2027-03-02	U-1529		2014-07-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021713-001	8759350	2027-03-02	U-1529		2014-07-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021713-001	8759350	2027-03-02	U-1529		2014-07-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021713-001	8759350	2027-03-02	U-1529		2014-07-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021713-001	8759350	2027-03-02	U-1529		2014-07-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021713-001	8759350	2027-03-02	U-1529		2014-07-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021713-001	7053092	2022-01-28	U-839			`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021713-001	8642600	2022-01-28	U-1492		2014-03-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021713-001	6977257	2022-04-24		Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021713-001	8642600*PED	2022-07-28		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021713-001	6977257*PED	2022-10-24		Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021713-001	9387182	2023-12-25	U-1529		2016-08-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021713-001	8759350	2027-03-02	U-1529		2014-07-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021713-001	7053092	2022-01-28	U-839			`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021713-001	8642600	2022-01-28	U-1492		2014-03-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021713-001	6977257	2022-04-24		Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021713-001	8642600*PED	2022-07-28		Pediatric extension		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021713-001	6977257*PED	2022-10-24		Pediatric extension		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021713-001	9387182	2023-12-25	U-1529		2016-08-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021713-001	8759350	2027-03-02	U-1529		2014-07-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021713-001	7053092	2022-01-28	U-839			`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021713-001	8642600	2022-01-28	U-1492		2014-03-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021713-001	6977257	2022-04-24		Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021713-001	8642600*PED	2022-07-28		Pediatric extension		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021713-001	6977257*PED	2022-10-24		Pediatric extension		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021713-001	9387182	2023-12-25	U-1529		2016-08-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021713-001	8759350	2027-03-02	U-1529		2014-07-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021713-001	7053092	2022-01-28	U-839			`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021713-001	8642600	2022-01-28	U-1492		2014-03-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021713-001	6977257	2022-04-24		Drug product		`74a2ff9319b5…`

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	N021713-001	ODE-80	2021-12-12	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021713-001	ODE-80	2021-12-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021713-001	ODE-80	2021-12-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021713-001	ODE-80	2021-12-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021713-001	ODE-80	2021-12-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021713-001	ODE-80	2021-12-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021713-001	ODE-80	2021-12-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021713-001	ODE-80	2021-12-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021713-001	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 1 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.	b72c0cff-9f4d-42e2-b884-d06dea3e6378	2026-09-08	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
aripiprazole	ARIPIPRAZOLE	Apotex Corp.	14910dae-da81-3d73-d0a4-e98d13917c69	2026-09-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	1d593ada-256d-4dec-9a26-2a6a67d97205	2026-07-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	bc3fde41-2f24-44e2-815d-15fe55bd68b3	2026-07-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	506fa28f-6f98-4632-bce8-72a9cb507c90	2026-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	f713c38e-cc49-4243-96b9-32d5dbbcf9cb	2026-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	1ad7d167-1235-4c5c-8159-da8972240ede	2026-07-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Aurobindo Pharma Limited	7bf7d35e-46a1-4e8f-aeb5-8a93223a4abc	2026-07-23	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	119e3387-39a2-4fe5-904b-c2d008425c0a	2026-07-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	99747897-22fe-4bee-9942-6349c0c8f6b0	2026-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Aurobindo Pharma Limited	476b92f3-cf7b-4c09-ac67-6ed35e6811d5	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Coupler LLC	56439ef6-a07e-34c9-e063-6294a90a77c3	2026-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Coupler LLC	55f3a705-9412-0f88-e063-6294a90a2b53	2026-07-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Coupler LLC	55f446b0-caa2-aca8-e063-6294a90af441	2026-07-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	a1191a90-eb83-4a59-948c-b9774d2c83a5	2026-07-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	69af5199-f872-4298-8d09-035e2127d3d4	2026-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Unit Dose Solutions, Inc.	535f4fbd-b6a7-7611-e063-6294a90a5c43	2026-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Coupler LLC	52cc86ba-2c4f-1aba-e063-6294a90a844e	2026-05-27	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Coupler LLC	52bbfc8f-fa17-839e-e063-6394a90a6316	2026-05-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Major Pharmaceuticals	573c6bb6-941f-4413-8c23-826025385864	2026-05-21	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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59148-013	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-013	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-013	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
61823	SUPPL	2020-02-06
61822	SUPPL	2020-02-06
61821	SUPPL	2020-02-06
61820	SUPPL	2020-02-06
61797	SUPPL	2020-02-06
61796	SUPPL	2020-02-06
59636	SUPPL	2019-08-08
59635	SUPPL	2019-08-08
59623	SUPPL	2019-08-08
47425	SUPPL	2017-03-02
47329	SUPPL	2017-02-24
45103	SUPPL	2016-08-23
45148	SUPPL	2016-08-18
16247	SUPPL	2016-01-22
6037	SUPPL	2016-01-20
37510	SUPPL	2014-12-15
28449	SUPPL	2014-12-15
28447	SUPPL	2014-07-11
16245	SUPPL	2014-06-10
16246	SUPPL	2013-08-09
28448	SUPPL	2013-08-05
6036	SUPPL	2012-02-27
16244	SUPPL	2012-02-24
42281	SUPPL	2012-01-27
21787	SUPPL	2012-01-27
21786	SUPPL	2012-01-27
44147	ORIG	2011-12-22
6035	SUPPL	2011-03-08
16243	SUPPL	2011-03-07
37507	SUPPL	2011-02-24
6033	SUPPL	2011-02-18
6034	SUPPL	2010-12-07
37509	SUPPL	2010-12-03
28446	SUPPL	2010-12-03
37508	SUPPL	2010-12-02
28445	SUPPL	2009-07-24
37506	SUPPL	2009-07-23
37505	SUPPL	2008-08-26
28444	SUPPL	2008-08-19
44644	SUPPL	2008-07-17
24210	SUPPL	2008-07-17
24209	SUPPL	2008-07-17
28442	SUPPL	2008-05-14
28441	SUPPL	2008-05-14
28440	SUPPL	2008-05-14
28443	SUPPL	2008-03-07
6032	SUPPL	2008-02-29
16242	SUPPL	2008-02-28
28439	SUPPL	2007-11-19
16241	SUPPL	2007-11-19
28438	SUPPL	2007-11-08
37504	SUPPL	2007-11-07
28437	SUPPL	2007-10-04
16240	SUPPL	2007-09-26
37502	SUPPL	2006-10-23
28435	SUPPL	2006-10-23
42280	ORIG	2006-09-27
37503	SUPPL	2006-09-20
28436	SUPPL	2006-09-20
16239	SUPPL	2006-02-22
6031	SUPPL	2006-02-22
37501	SUPPL	2005-06-23
6030	SUPPL	2005-06-23
16238	SUPPL	2005-03-03
6029	SUPPL	2005-03-03
37500	ORIG	2004-12-10
28434	ORIG	2004-12-10
51606	SUPPL	1900-01-01