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 4 of 6 · 116 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aripiprazole	ARIPIPRAZOLE	Macleods Pharmaceuticals Limited	ab4245a1-71f7-45be-a2ef-b0636ed3cc20	2025-03-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Amneal Pharmaceuticals LLC	7f272100-e02f-4a16-bb39-a2bf844db4f9	2025-02-25	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Amneal Pharmaceuticals LLC	06dda03f-8481-46d6-af02-4f51e1a3a065	2025-02-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Unichem Pharmaceuticals (USA), Inc.	349b8a7b-5ada-4f5c-a269-a86806c6b520	2025-02-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Alembic Pharmaceuticals Inc.	de2dc5fd-ecb4-4445-9cfb-10e64fe3269d	2025-02-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
OPIPZA	ARIPIPRAZOLE	Carwin Pharmaceutical Associates, LLC	b47ede68-8942-4432-af7e-57afc14b2ba4	2025-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
ABILIFY	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	c040bd1d-45b7-49f2-93ea-aed7220b30ac	2025-01-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ABILIFY generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Lannett Company, Inc.	e7292c4c-e332-4ed4-9086-f130d223b6ae	2025-01-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Direct_Rx	f823bc23-27f3-2397-e053-6294a90a365a	2025-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Direct_Rx	f81d9b82-5879-3c0a-e053-6294a90ac23e	2025-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Direct_Rx	facdb9a9-612f-e59a-e053-6394a90a1fa7	2025-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Direct_Rx	fcea91c3-e428-8991-e053-6394a90a099d	2025-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Bionpharma Inc.	720bc395-777d-4e5d-9571-aad5827dbf6d	2025-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Viona Pharmaceuticals Inc.	73c5e380-b7b1-4362-a827-71881574ff48	2025-01-16	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Preferred Pharmaceuticals Inc.	34127431-6ad7-402f-bc22-1429c55d921c	2025-01-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Preferred Pharmaceuticals, Inc.	4894031e-639e-49d8-927a-76d684bf6655	2025-01-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
aripiprazole	ARIPIPRAZOLE	Preferred Pharmaceuticals Inc.	faa3032b-d9a1-45dd-88be-abb432223f13	2025-01-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Prefferred Pharmaceuticals Inc.	fbb3ac69-8dba-42df-8d6d-ef3d79241edb	2025-01-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	NuCare Pharmaceuticals, Inc.	27874fe2-3fd6-002d-e063-6294a90a4cd7	2024-11-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	e7b6a156-8001-441c-bfd3-bf8987a339e8	2024-10-30	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