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 3 of 6 · 116 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aripiprazole	ARIPIPRAZOLE	Advagen Pharma Ltd	4537e26b-dcf8-4a78-ab7d-57359b1d2192	2025-12-02	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Dr.Reddys Laboratories Inc	178f09f0-e08e-452b-b817-717c5c49e110	2025-10-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
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	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

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