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 3 of 7 · 121 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ARIPIPRAZOLE	ARIPIPRAZOLE	QUAGEN PHARMACEUTICALS LLC	b12f1ff2-c0b5-47e7-8075-bf2ce79fdaf8	2025-12-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ARIPIPRAZOLE generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Quallent Pharmaceuticals Health LLC	0e0d42ad-f4c6-4e30-adc2-ab1d122428ec	2025-12-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Advagen Pharma Ltd	4537e26b-dcf8-4a78-ab7d-57359b1d2192	2025-12-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Dr.Reddys Laboratories Inc	178f09f0-e08e-452b-b817-717c5c49e110	2025-10-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	NuCare Pharmaceuticals, Inc.	414b7fd2-6a63-af39-e063-6394a90a00b8	2025-10-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	PD-Rx Pharmaceuticals, Inc.	0cf6655e-d59a-4ebd-9698-195cad2adbd5	2025-10-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Ajanta Pharma USA Inc.	d0f910b5-adef-4a93-9369-70f1ed541503	2025-10-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
ARIPIPRAZOLE	ARIPIPRAZOLE	Accord Healthcare, Inc.	85cc7d25-414b-4b6f-a03a-48af908a16a1	2025-10-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ARIPIPRAZOLE generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Ascend Laboratories, LLC	c7040fef-96a7-4429-9a8e-ec3ab17a8019	2025-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	AvPAK	7df4c83e-13d8-25b1-57eb-08d26ba03565	2025-08-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	NuCare Pharmaceuticals, Inc.	3cf72cc6-ae43-bfd5-e063-6294a90a18b0	2025-08-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	American Health Packaging	80e079f0-faf5-4c0c-b1a8-9bc3cc2cde00	2025-08-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
aripiprazole	ARIPIPRAZOLE	Proficient Rx LP	2c2b0172-b186-4be4-a002-4a26adf120c6	2025-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: aripiprazole generic name: ARIPIPRAZOLE
aripiprazole	ARIPIPRAZOLE	Proficient Rx LP	a3c0be94-c6c0-47e2-892f-c51f100fb3a3	2025-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Alembic Pharmaceuticals Inc.	a10a5427-58b1-42dd-964c-3f8c78770534	2025-06-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	NuCare Pharmaceuticals,Inc.	3726d102-dd9f-645e-e063-6294a90aeb9e	2025-06-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	A-S Medication Solutions	a8edb057-18a3-446d-8af0-672c97933a88	2025-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole 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 brand name: aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Chartwell RX, LLC	1d27462e-45c7-4335-9092-84c340e06a2c	2025-05-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	385301f5-e59d-42d5-8544-aadf0ee0c967	2025-04-29	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