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001	ABILIFY	ARIPIPRAZOLE	SOLUTION;ORAL	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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 1.

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N021713-001	ABILIFY	ARIPIPRAZOLE	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2004-12-10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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 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UTC	2026-02	N021713-001	ABILIFY	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2004-12-10	`011fe1cb6892…`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of this ZIP	2025-12	N021713-001	ABILIFY	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2004-12-10	`31067a03dcf5…`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UTC	2025-08	N021713-001	ABILIFY	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL	RLD	2004-12-10	`6a471c1ec25d…`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…`
2022-09-29 23:25 UTC	2022-09	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	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	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	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 155 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
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…`
2019-12-13 00:20 UTC	2019-12	N021713-001	8642600*PED	2022-07-28		Pediatric extension		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021713-001	6977257*PED	2022-10-24		Pediatric extension		`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 3 of 6 · 116 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aripiprazole	ARIPIPRAZOLE	NuCare Pharmaceuticals, Inc.	414b7fd2-6a63-af39-e063-6394a90a00b8	2025-10-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	PD-Rx Pharmaceuticals, Inc.	0cf6655e-d59a-4ebd-9698-195cad2adbd5	2025-10-14	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Ajanta Pharma USA Inc.	d0f910b5-adef-4a93-9369-70f1ed541503	2025-10-10	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
ARIPIPRAZOLE	ARIPIPRAZOLE	Accord Healthcare, Inc.	85cc7d25-414b-4b6f-a03a-48af908a16a1	2025-10-06	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Ascend Laboratories, LLC	c7040fef-96a7-4429-9a8e-ec3ab17a8019	2025-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	AvPAK	7df4c83e-13d8-25b1-57eb-08d26ba03565	2025-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	NuCare Pharmaceuticals, Inc.	3cf72cc6-ae43-bfd5-e063-6294a90a18b0	2025-08-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	American Health Packaging	80e079f0-faf5-4c0c-b1a8-9bc3cc2cde00	2025-08-13	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
aripiprazole	ARIPIPRAZOLE	Proficient Rx LP	2c2b0172-b186-4be4-a002-4a26adf120c6	2025-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
aripiprazole	ARIPIPRAZOLE	Proficient Rx LP	a3c0be94-c6c0-47e2-892f-c51f100fb3a3	2025-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Alembic Pharmaceuticals Inc.	a10a5427-58b1-42dd-964c-3f8c78770534	2025-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
aripiprazole	ARIPIPRAZOLE	Apotex Corp.	14910dae-da81-3d73-d0a4-e98d13917c69	2025-06-12	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	NuCare Pharmaceuticals,Inc.	3726d102-dd9f-645e-e063-6294a90aeb9e	2025-06-09	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	A-S Medication Solutions	a8edb057-18a3-446d-8af0-672c97933a88	2025-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
aripiprazole	ARIPIPRAZOLE	ST. MARY'S MEDICAL PARK PHARMACY	35a86989-862e-b0bb-e063-6394a90a7ec1	2025-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Chartwell RX, LLC	1d27462e-45c7-4335-9092-84c340e06a2c	2025-05-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	385301f5-e59d-42d5-8544-aadf0ee0c967	2025-04-29	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Abilify Asimtufii	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc	da4c07fd-1130-4341-bb44-63acfa4162be	2025-04-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
aripiprazole	ARIPIPRAZOLE	Torrent Pharmaceuticals Limited	3988e66f-339c-451e-9f8a-9d0c0a2a381b	2025-03-28	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Macleods Pharmaceuticals Limited	ab4245a1-71f7-45be-a2ef-b0636ed3cc20	2025-03-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE

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