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 42.

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
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…`
2022-09-29 23:25 UTC	2022-09	A078608-001	ARIPIPRAZOLE	10MG	TABLET / ORAL	2015-04-28	`e64feba35796…`

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 1 of 7 · 121 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	1d593ada-256d-4dec-9a26-2a6a67d97205	2026-07-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	bc3fde41-2f24-44e2-815d-15fe55bd68b3	2026-07-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	506fa28f-6f98-4632-bce8-72a9cb507c90	2026-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	f713c38e-cc49-4243-96b9-32d5dbbcf9cb	2026-07-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	1ad7d167-1235-4c5c-8159-da8972240ede	2026-07-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Aurobindo Pharma Limited	7bf7d35e-46a1-4e8f-aeb5-8a93223a4abc	2026-07-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	119e3387-39a2-4fe5-904b-c2d008425c0a	2026-07-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE ORALLY DISINTEGRATING	Dr. Reddy's Laboratories Inc	394ea4a4-3991-4f98-b38f-56e9335d66b3	2026-07-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	99747897-22fe-4bee-9942-6349c0c8f6b0	2026-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Aurobindo Pharma Limited	476b92f3-cf7b-4c09-ac67-6ed35e6811d5	2026-07-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE ORAL	ATLANTIC BIOLOGICALS CORP.	042b725c-1c17-4cfb-80b2-c841226d795e	2026-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole
Aripiprazole	ARIPIPRAZOLE	Coupler LLC	56439ef6-a07e-34c9-e063-6294a90a77c3	2026-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Coupler LLC	55f3a705-9412-0f88-e063-6294a90a2b53	2026-07-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Coupler LLC	55f446b0-caa2-aca8-e063-6294a90af441	2026-07-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	a1191a90-eb83-4a59-948c-b9774d2c83a5	2026-07-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	69af5199-f872-4298-8d09-035e2127d3d4	2026-06-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Unit Dose Solutions, Inc.	535f4fbd-b6a7-7611-e063-6294a90a5c43	2026-06-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Coupler LLC	52cc86ba-2c4f-1aba-e063-6294a90a844e	2026-05-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Coupler LLC	52bbfc8f-fa17-839e-e063-6394a90a6316	2026-05-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Major Pharmaceuticals	573c6bb6-941f-4413-8c23-826025385864	2026-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE

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