Application 021866

Type: NDA
Sponsor: OTSUKA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ABILIFY	ARIPIPRAZOLE	INJECTABLE;INTRAMUSCULAR	9.75MG/1.3ML (7.5MG/ML)	No	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
N021866-001	ABILIFY	ARIPIPRAZOLE	9.75MG/1.3ML (7.5MG/ML)	INJECTABLE / INTRAMUSCULAR			2006-09-20

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021866-001	ABILIFY	9.75MG/1.3ML (7.5MG/ML)	INJECTABLE / INTRAMUSCULAR	2006-09-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021866-001	ABILIFY	9.75MG/1.3ML (7.5MG/ML)	INJECTABLE / INTRAMUSCULAR	2006-09-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021866-001	ABILIFY	9.75MG/1.3ML (7.5MG/ML)	INJECTABLE / INTRAMUSCULAR	2006-09-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021866-001	ABILIFY	9.75MG/1.3ML (7.5MG/ML)	INJECTABLE / INTRAMUSCULAR	2006-09-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021866-001	ABILIFY	9.75MG/1.3ML (7.5MG/ML)	INJECTABLE / INTRAMUSCULAR	2006-09-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021866-001	ABILIFY	9.75MG/1.3ML (7.5MG/ML)	INJECTABLE / INTRAMUSCULAR	2006-09-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021866-001	ABILIFY	9.75MG/1.3ML (7.5MG/ML)	INJECTABLE / INTRAMUSCULAR	2006-09-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021866-001	ABILIFY	9.75MG/1.3ML (7.5MG/ML)	INJECTABLE / INTRAMUSCULAR	2006-09-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021866-001	ABILIFY	9.75MG/1.3ML (7.5MG/ML)	INJECTABLE / INTRAMUSCULAR	2006-09-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021866-001	ABILIFY	9.75MG/1.3ML (7.5MG/ML)	INJECTABLE / INTRAMUSCULAR	2006-09-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021866-001	ABILIFY	9.75MG/1.3ML (7.5MG/ML)	INJECTABLE / INTRAMUSCULAR	2006-09-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021866-001	ABILIFY	9.75MG/1.3ML (7.5MG/ML)	INJECTABLE / INTRAMUSCULAR	2006-09-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021866-001	ABILIFY	9.75MG/1.3ML (7.5MG/ML)	INJECTABLE / INTRAMUSCULAR	2006-09-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021866-001	ABILIFY	9.75MG/1.3ML (7.5MG/ML)	INJECTABLE / INTRAMUSCULAR	2006-09-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021866-001	ABILIFY	9.75MG/1.3ML (7.5MG/ML)	INJECTABLE / INTRAMUSCULAR	2006-09-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021866-001	ABILIFY	9.75MG/1.3ML (7.5MG/ML)	INJECTABLE / INTRAMUSCULAR	2006-09-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021866-001	ABILIFY	9.75MG/1.3ML (7.5MG/ML)	INJECTABLE / INTRAMUSCULAR	2006-09-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021866-001	ABILIFY	9.75MG/1.3ML (7.5MG/ML)	INJECTABLE / INTRAMUSCULAR	2006-09-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021866-001	ABILIFY	9.75MG/1.3ML (7.5MG/ML)	INJECTABLE / INTRAMUSCULAR	2006-09-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021866-001	ABILIFY	9.75MG/1.3ML (7.5MG/ML)	INJECTABLE / INTRAMUSCULAR	2006-09-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021866-001	ABILIFY	9.75MG/1.3ML (7.5MG/ML)	INJECTABLE / INTRAMUSCULAR	2006-09-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021866-001	ABILIFY	9.75MG/1.3ML (7.5MG/ML)	INJECTABLE / INTRAMUSCULAR	2006-09-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021866-001	ABILIFY	9.75MG/1.3ML (7.5MG/ML)	INJECTABLE / INTRAMUSCULAR	2006-09-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021866-001	ABILIFY	9.75MG/1.3ML (7.5MG/ML)	INJECTABLE / INTRAMUSCULAR	2006-09-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021866-001	ABILIFY	9.75MG/1.3ML (7.5MG/ML)	INJECTABLE / INTRAMUSCULAR	2006-09-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021866-001	ABILIFY	9.75MG/1.3ML (7.5MG/ML)	INJECTABLE / INTRAMUSCULAR	2006-09-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021866-001	ABILIFY	9.75MG/1.3ML (7.5MG/ML)	INJECTABLE / INTRAMUSCULAR	2006-09-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021866-001	ABILIFY	9.75MG/1.3ML (7.5MG/ML)	INJECTABLE / INTRAMUSCULAR	2006-09-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021866-001	ABILIFY	9.75MG/1.3ML (7.5MG/ML)	INJECTABLE / INTRAMUSCULAR	2006-09-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021866-001	ABILIFY	9.75MG/1.3ML (7.5MG/ML)	INJECTABLE / INTRAMUSCULAR	2006-09-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021866-001	ABILIFY	9.75MG/1.3ML (7.5MG/ML)	INJECTABLE / INTRAMUSCULAR	2006-09-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021866-001	ABILIFY	9.75MG/1.3ML (7.5MG/ML)	INJECTABLE / INTRAMUSCULAR	2006-09-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021866-001	ABILIFY	9.75MG/1.3ML (7.5MG/ML)	INJECTABLE / INTRAMUSCULAR	2006-09-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021866-001	ABILIFY	9.75MG/1.3ML (7.5MG/ML)	INJECTABLE / INTRAMUSCULAR	2006-09-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021866-001	ABILIFY	9.75MG/1.3ML (7.5MG/ML)	INJECTABLE / INTRAMUSCULAR	2006-09-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021866-001	ABILIFY	9.75MG/1.3ML (7.5MG/ML)	INJECTABLE / INTRAMUSCULAR	2006-09-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021866-001	ABILIFY	9.75MG/1.3ML (7.5MG/ML)	INJECTABLE / INTRAMUSCULAR	2006-09-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021866-001	ABILIFY	9.75MG/1.3ML (7.5MG/ML)	INJECTABLE / INTRAMUSCULAR	2006-09-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021866-001	ABILIFY	9.75MG/1.3ML (7.5MG/ML)	INJECTABLE / INTRAMUSCULAR	2006-09-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021866-001	ABILIFY	9.75MG/1.3ML (7.5MG/ML)	INJECTABLE / INTRAMUSCULAR	2006-09-20	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 150 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021866-001	7115587	2024-07-21	U-764	Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021866-001	7550445	2024-07-21		Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021866-001	7115587*PED	2025-01-21		Pediatric extension	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021866-001	7550445*PED	2025-01-21		Pediatric extension	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021866-001	7115587*PED	2025-01-21		Pediatric extension	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021866-001	7550445*PED	2025-01-21		Pediatric extension	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021866-001	7115587*PED	2025-01-21		Pediatric extension	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021866-001	7550445*PED	2025-01-21		Pediatric extension	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021866-001	7115587*PED	2025-01-21		Pediatric extension	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021866-001	7550445*PED	2025-01-21		Pediatric extension	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021866-001	7115587	2024-07-21	U-764	Drug product	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021866-001	7550445	2024-07-21		Drug product	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021866-001	7115587*PED	2025-01-21		Pediatric extension	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021866-001	7550445*PED	2025-01-21		Pediatric extension	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021866-001	7115587	2024-07-21	U-764	Drug product	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021866-001	7550445	2024-07-21		Drug product	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021866-001	7115587*PED	2025-01-21		Pediatric extension	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021866-001	7550445*PED	2025-01-21		Pediatric extension	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021866-001	7115587	2024-07-21	U-764	Drug product	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021866-001	7550445	2024-07-21		Drug product	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021866-001	7115587*PED	2025-01-21		Pediatric extension	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021866-001	7550445*PED	2025-01-21		Pediatric extension	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021866-001	7115587	2024-07-21	U-764	Drug product	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021866-001	7550445	2024-07-21		Drug product	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021866-001	7115587*PED	2025-01-21		Pediatric extension	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021866-001	7550445*PED	2025-01-21		Pediatric extension	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021866-001	7115587	2024-07-21	U-764	Drug product	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021866-001	7550445	2024-07-21		Drug product	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021866-001	7115587*PED	2025-01-21		Pediatric extension	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021866-001	7550445*PED	2025-01-21		Pediatric extension	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021866-001	7115587	2024-07-21	U-764	Drug product	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021866-001	7550445	2024-07-21		Drug product	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021866-001	7115587*PED	2025-01-21		Pediatric extension	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021866-001	7550445*PED	2025-01-21		Pediatric extension	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021866-001	7115587	2024-07-21	U-764	Drug product	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021866-001	7550445	2024-07-21		Drug product	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021866-001	7115587*PED	2025-01-21		Pediatric extension	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021866-001	7550445*PED	2025-01-21		Pediatric extension	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021866-001	7115587	2024-07-21	U-764	Drug product	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021866-001	7550445	2024-07-21		Drug product	`1e350fbaab3a…`

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	N021866-001	ODE-80	2021-12-12	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021866-001	ODE-80	2021-12-12	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021866-001	ODE-80	2021-12-12	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021866-001	ODE-80	2021-12-12	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021866-001	ODE-80	2021-12-12	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021866-001	ODE-80	2021-12-12	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021866-001	ODE-80	2021-12-12	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021866-001	ODE-80	2021-12-12	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021866-001	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 2 of 6 · 116 matching rows.

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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59148-016	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-016	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current
59148-016	ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
61831	SUPPL	2020-02-06
61830	SUPPL	2020-02-06
61829	SUPPL	2020-02-06
61828	SUPPL	2020-02-06
61801	SUPPL	2020-02-06
61800	SUPPL	2020-02-06
59640	SUPPL	2019-08-08
59639	SUPPL	2019-08-08
59625	SUPPL	2019-08-08
47427	SUPPL	2017-03-02
47327	SUPPL	2017-02-24
45052	SUPPL	2016-08-23
45053	SUPPL	2016-08-18
37792	SUPPL	2016-01-22
6342	SUPPL	2016-01-20
16485	SUPPL	2014-12-15
6341	SUPPL	2014-12-15
6339	SUPPL	2014-07-11
37790	SUPPL	2014-06-10
37791	SUPPL	2013-08-09
6340	SUPPL	2013-08-05
28743	SUPPL	2012-02-27
37789	SUPPL	2012-02-24
42333	SUPPL	2012-01-27
42332	SUPPL	2012-01-27
21847	SUPPL	2012-01-27
44158	ORIG	2011-12-22
28742	SUPPL	2011-03-08
37788	SUPPL	2011-03-07
37786	SUPPL	2011-02-24
6337	SUPPL	2011-02-18
28741	SUPPL	2010-12-07
16484	SUPPL	2010-12-03
6338	SUPPL	2010-12-03
37787	SUPPL	2010-12-02
28740	SUPPL	2010-02-17
28733	SUPPL	2010-02-14
16481	SUPPL	2010-02-14
28739	SUPPL	2009-07-24
37785	SUPPL	2009-07-23
37784	SUPPL	2008-08-26
28738	SUPPL	2008-08-19
24222	ORIG	2008-08-12
21846	ORIG	2008-08-11
44655	SUPPL	2008-07-17
44654	SUPPL	2008-07-17
44653	SUPPL	2008-07-17
28736	SUPPL	2008-05-14
28735	SUPPL	2008-05-14
6335	SUPPL	2008-05-14
28737	SUPPL	2008-03-07
6336	SUPPL	2008-02-29
16483	SUPPL	2008-02-28
37783	SUPPL	2007-11-19
28734	SUPPL	2007-11-19
6334	SUPPL	2007-11-08
16482	SUPPL	2007-11-07
28732	SUPPL	2007-10-04
16480	SUPPL	2007-09-26
6333	ORIG	2006-09-25
37782	ORIG	2006-09-21
51608	SUPPL	1900-01-01