Application 078608

Type: ANDA
Sponsor: TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ARIPIPRAZOLE	ARIPIPRAZOLE	TABLET;ORAL	10MG	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
A078608-001	ARIPIPRAZOLE	ARIPIPRAZOLE	10MG	TABLET / ORAL			2015-04-28

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	A078608-001	ARIPIPRAZOLE	10MG	TABLET / ORAL	2015-04-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078608-001	ARIPIPRAZOLE	10MG	TABLET / ORAL	2015-04-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078608-001	ARIPIPRAZOLE	10MG	TABLET / ORAL	2015-04-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078608-001	ARIPIPRAZOLE	10MG	TABLET / ORAL	2015-04-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078608-001	ARIPIPRAZOLE	10MG	TABLET / ORAL	2015-04-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078608-001	ARIPIPRAZOLE	10MG	TABLET / ORAL	2015-04-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078608-001	ARIPIPRAZOLE	10MG	TABLET / ORAL	2015-04-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078608-001	ARIPIPRAZOLE	10MG	TABLET / ORAL	2015-04-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078608-001	ARIPIPRAZOLE	10MG	TABLET / ORAL	2015-04-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078608-001	ARIPIPRAZOLE	10MG	TABLET / ORAL	2015-04-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078608-001	ARIPIPRAZOLE	10MG	TABLET / ORAL	2015-04-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078608-001	ARIPIPRAZOLE	10MG	TABLET / ORAL	2015-04-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078608-001	ARIPIPRAZOLE	10MG	TABLET / ORAL	2015-04-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078608-001	ARIPIPRAZOLE	10MG	TABLET / ORAL	2015-04-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078608-001	ARIPIPRAZOLE	10MG	TABLET / ORAL	2015-04-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078608-001	ARIPIPRAZOLE	10MG	TABLET / ORAL	2015-04-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078608-001	ARIPIPRAZOLE	10MG	TABLET / ORAL	2015-04-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078608-001	ARIPIPRAZOLE	10MG	TABLET / ORAL	2015-04-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078608-001	ARIPIPRAZOLE	10MG	TABLET / ORAL	2015-04-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078608-001	ARIPIPRAZOLE	10MG	TABLET / ORAL	2015-04-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078608-001	ARIPIPRAZOLE	10MG	TABLET / ORAL	2015-04-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078608-001	ARIPIPRAZOLE	10MG	TABLET / ORAL	2015-04-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078608-001	ARIPIPRAZOLE	10MG	TABLET / ORAL	2015-04-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078608-001	ARIPIPRAZOLE	10MG	TABLET / ORAL	2015-04-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078608-001	ARIPIPRAZOLE	10MG	TABLET / ORAL	2015-04-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078608-001	ARIPIPRAZOLE	10MG	TABLET / ORAL	2015-04-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078608-001	ARIPIPRAZOLE	10MG	TABLET / ORAL	2015-04-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078608-001	ARIPIPRAZOLE	10MG	TABLET / ORAL	2015-04-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078608-001	ARIPIPRAZOLE	10MG	TABLET / ORAL	2015-04-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078608-001	ARIPIPRAZOLE	10MG	TABLET / ORAL	2015-04-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078608-001	ARIPIPRAZOLE	10MG	TABLET / ORAL	2015-04-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078608-001	ARIPIPRAZOLE	10MG	TABLET / ORAL	2015-04-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078608-001	ARIPIPRAZOLE	10MG	TABLET / ORAL	2015-04-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078608-001	ARIPIPRAZOLE	10MG	TABLET / ORAL	2015-04-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078608-001	ARIPIPRAZOLE	10MG	TABLET / ORAL	2015-04-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078608-001	ARIPIPRAZOLE	10MG	TABLET / ORAL	2015-04-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078608-001	ARIPIPRAZOLE	10MG	TABLET / ORAL	2015-04-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078608-001	ARIPIPRAZOLE	10MG	TABLET / ORAL	2015-04-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078608-001	ARIPIPRAZOLE	10MG	TABLET / ORAL	2015-04-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078608-001	ARIPIPRAZOLE	10MG	TABLET / ORAL	2015-04-28	`f41ea6bd6efb…`

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 7 · 121 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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 brand name: aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Macleods Pharmaceuticals Limited	ab4245a1-71f7-45be-a2ef-b0636ed3cc20	2025-03-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Amneal Pharmaceuticals LLC	7f272100-e02f-4a16-bb39-a2bf844db4f9	2025-02-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Amneal Pharmaceuticals LLC	06dda03f-8481-46d6-af02-4f51e1a3a065	2025-02-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Unichem Pharmaceuticals (USA), Inc.	349b8a7b-5ada-4f5c-a269-a86806c6b520	2025-02-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE ORAL	Camber Pharmaceuticals, Inc.	da47ad78-e62c-4bf3-9b53-d8cc246bcfb6	2025-02-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole
Aripiprazole	ARIPIPRAZOLE	Alembic Pharmaceuticals Inc.	de2dc5fd-ecb4-4445-9cfb-10e64fe3269d	2025-02-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole 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 generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Lannett Company, Inc.	e7292c4c-e332-4ed4-9086-f130d223b6ae	2025-01-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Direct_Rx	f823bc23-27f3-2397-e053-6294a90a365a	2025-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Direct_Rx	f81d9b82-5879-3c0a-e053-6294a90ac23e	2025-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Direct_Rx	facdb9a9-612f-e59a-e053-6394a90a1fa7	2025-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Direct_Rx	fcea91c3-e428-8991-e053-6394a90a099d	2025-01-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Bionpharma Inc.	720bc395-777d-4e5d-9571-aad5827dbf6d	2025-01-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Viona Pharmaceuticals Inc.	73c5e380-b7b1-4362-a827-71881574ff48	2025-01-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Preferred Pharmaceuticals Inc.	34127431-6ad7-402f-bc22-1429c55d921c	2025-01-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Preferred Pharmaceuticals, Inc.	4894031e-639e-49d8-927a-76d684bf6655	2025-01-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
aripiprazole	ARIPIPRAZOLE	Preferred Pharmaceuticals Inc.	faa3032b-d9a1-45dd-88be-abb432223f13	2025-01-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: aripiprazole 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
0093-7580	Aripiprazole	Aripiprazole	Teva Pharmaceuticals USA, Inc.	ANDA	Current
70518-0678	Aripiprazole	Aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-0678	Aripiprazole	Aripiprazole	REMEDYREPACK INC.	ANDA	Current