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 5 of 7 · 121 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aripiprazole	ARIPIPRAZOLE	Prefferred Pharmaceuticals Inc.	fbb3ac69-8dba-42df-8d6d-ef3d79241edb	2025-01-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	NuCare Pharmaceuticals, Inc.	27874fe2-3fd6-002d-e063-6294a90a4cd7	2024-11-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE ORALLY DISINTEGRATING	ScieGen Pharmaceuticals Inc	4bcfd5a7-bec7-4426-9314-17daaf715cad	2024-11-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole
aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	e7b6a156-8001-441c-bfd3-bf8987a339e8	2024-10-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: aripiprazole generic name: ARIPIPRAZOLE
aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	b62837db-1949-4dba-9e2f-714a9f136f5a	2024-10-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: aripiprazole generic name: ARIPIPRAZOLE
aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	d130836c-5f1c-4779-ac6c-6350752dc015	2024-10-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	NCS HealthCare of KY, LLC dba Vangard Labs	d8183eaf-0093-4720-b8ed-20e570697511	2024-10-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	A-S Medication Solutions	bf3cf835-4c4e-47cb-be9c-bcb7c2e11cbe	2024-10-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Aurobindo Pharma Limited	fcabd777-dcb7-452c-821c-575a5991c90a	2024-10-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	VistaPharm, LLC	06529caf-698f-41da-81ec-d0ba5ab200d7	2024-09-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	ee33be35-abc8-453f-98e9-7974026b7eb0	2024-08-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	A-S Medication Solutions	c8a94428-b6d2-428b-a3a5-7b983d572fab	2024-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
aripiprazole	ARIPIPRAZOLE	A-S Medication Solutions	ab3973f3-3db8-4db2-8258-1b21af7b6380	2024-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	A-S Medication Solutions	13339e7f-a8b4-430d-b623-47372de98348	2024-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	A-S Medication Solutions	3ab6af7c-3169-46bf-bd3f-697c81bbcede	2024-06-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
ARIPIPRAZOLE	ARIPIPRAZOLE	Solco Healthcare U.S., LLC	abb8ad7e-7998-4485-a09f-a2892190f4ad	2024-04-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ARIPIPRAZOLE generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	A-S Medication Solutions	89c2cddc-2ae3-4505-adf9-018542c713bf	2024-04-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	3c0109f6-0549-4f91-a259-d9d6d7329b91	2024-04-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	6b0c3767-d397-4c7f-b229-083620d9ae6b	2024-04-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE ORAL	NorthStar RxLLC	4a0a2f6c-d7bb-48d1-b5ca-066f27f78e41	2024-04-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand 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