Application 078708

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	15MG	No	No
002	ARIPIPRAZOLE	ARIPIPRAZOLE	TABLET;ORAL	20MG	No	No
003	ARIPIPRAZOLE	ARIPIPRAZOLE	TABLET;ORAL	30MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A078708-001	ARIPIPRAZOLE	ARIPIPRAZOLE	15MG	TABLET / ORAL	2015-04-28
A078708-002	ARIPIPRAZOLE	ARIPIPRAZOLE	20MG	TABLET / ORAL	2015-04-28
A078708-003	ARIPIPRAZOLE	ARIPIPRAZOLE	30MG	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 4 · 129 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	A078708-001	ARIPIPRAZOLE	15MG	TABLET / ORAL	2015-04-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078708-002	ARIPIPRAZOLE	20MG	TABLET / ORAL	2015-04-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078708-003	ARIPIPRAZOLE	30MG	TABLET / ORAL	2015-04-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078708-001	ARIPIPRAZOLE	15MG	TABLET / ORAL	2015-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078708-002	ARIPIPRAZOLE	20MG	TABLET / ORAL	2015-04-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078708-003	ARIPIPRAZOLE	30MG	TABLET / ORAL	2015-04-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078708-001	ARIPIPRAZOLE	15MG	TABLET / ORAL	2015-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078708-002	ARIPIPRAZOLE	20MG	TABLET / ORAL	2015-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078708-003	ARIPIPRAZOLE	30MG	TABLET / ORAL	2015-04-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078708-001	ARIPIPRAZOLE	15MG	TABLET / ORAL	2015-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078708-002	ARIPIPRAZOLE	20MG	TABLET / ORAL	2015-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078708-003	ARIPIPRAZOLE	30MG	TABLET / ORAL	2015-04-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078708-001	ARIPIPRAZOLE	15MG	TABLET / ORAL	2015-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078708-002	ARIPIPRAZOLE	20MG	TABLET / ORAL	2015-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078708-003	ARIPIPRAZOLE	30MG	TABLET / ORAL	2015-04-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078708-001	ARIPIPRAZOLE	15MG	TABLET / ORAL	2015-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078708-002	ARIPIPRAZOLE	20MG	TABLET / ORAL	2015-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078708-003	ARIPIPRAZOLE	30MG	TABLET / ORAL	2015-04-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078708-001	ARIPIPRAZOLE	15MG	TABLET / ORAL	2015-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078708-002	ARIPIPRAZOLE	20MG	TABLET / ORAL	2015-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078708-003	ARIPIPRAZOLE	30MG	TABLET / ORAL	2015-04-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078708-001	ARIPIPRAZOLE	15MG	TABLET / ORAL	2015-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078708-002	ARIPIPRAZOLE	20MG	TABLET / ORAL	2015-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078708-003	ARIPIPRAZOLE	30MG	TABLET / ORAL	2015-04-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078708-001	ARIPIPRAZOLE	15MG	TABLET / ORAL	2015-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078708-002	ARIPIPRAZOLE	20MG	TABLET / ORAL	2015-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078708-003	ARIPIPRAZOLE	30MG	TABLET / ORAL	2015-04-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078708-001	ARIPIPRAZOLE	15MG	TABLET / ORAL	2015-04-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078708-002	ARIPIPRAZOLE	20MG	TABLET / ORAL	2015-04-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078708-003	ARIPIPRAZOLE	30MG	TABLET / ORAL	2015-04-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078708-001	ARIPIPRAZOLE	15MG	TABLET / ORAL	2015-04-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078708-002	ARIPIPRAZOLE	20MG	TABLET / ORAL	2015-04-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078708-003	ARIPIPRAZOLE	30MG	TABLET / ORAL	2015-04-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078708-001	ARIPIPRAZOLE	15MG	TABLET / ORAL	2015-04-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078708-002	ARIPIPRAZOLE	20MG	TABLET / ORAL	2015-04-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078708-003	ARIPIPRAZOLE	30MG	TABLET / ORAL	2015-04-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078708-001	ARIPIPRAZOLE	15MG	TABLET / ORAL	2015-04-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078708-002	ARIPIPRAZOLE	20MG	TABLET / ORAL	2015-04-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078708-003	ARIPIPRAZOLE	30MG	TABLET / ORAL	2015-04-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078708-001	ARIPIPRAZOLE	15MG	TABLET / ORAL	2015-04-28	`301d65b070ca…`

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 2 of 7 · 121 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	9b695d4b-3794-4b89-8575-6feb83697ccc	2026-05-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	c092a736-16e2-4dd0-8769-cb766a62f4d9	2026-05-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Coupler LLC	512874e6-6d00-2623-e063-6394a90aa4bc	2026-05-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Coupler LLC	50214c47-2ea3-b373-e063-6394a90aad23	2026-04-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	6f580e75-61ab-4c7b-bb3f-f027a9603f84	2026-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
ABILIFY MAINTENA	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	ee49f3b1-1650-47ff-9fb1-ea53fe0b92b6	2026-03-24	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	433cdc7d-465a-4ad4-bd84-cabd37e15f51	2026-03-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
aripiprazole	ARIPIPRAZOLE	Major Pharmaceuticals	969c17aa-6abc-413c-8561-f1ad8fdde3e5	2026-03-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Preferred Pharmaceuticals, Inc.	36fb0c13-dfae-46ac-bb71-0b53fe5649f4	2026-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Preferred Pharmaceuticals Inc.	02a4af27-c83c-4166-950c-7a1cb12d198d	2026-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	ff8dc838-ca1a-49d3-8938-5ae645574a75	2026-03-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	2bc00231-c2e7-4b9d-93a1-fb796fd8d591	2026-02-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	1e8d889e-126b-4627-a2cc-34f2d35a5d67	2026-01-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	1ef9e44f-5672-47c2-97e9-286e1b84417d	2026-01-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	4bda6f17-d87c-4009-b329-99275c56106f	2026-01-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	fb40b669-4e37-4087-8fb1-3ac140543602	2026-01-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	A-S Medication Solutions	554db933-aa80-4685-bcd5-58c84571c19c	2026-01-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Coupler LLC	47430dfa-9377-6c31-e063-6394a90a86a9	2025-12-31	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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-7581	Aripiprazole	Aripiprazole	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7582	Aripiprazole	Aripiprazole	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7583	Aripiprazole	Aripiprazole	Teva Pharmaceuticals USA, Inc.	ANDA	Current
70518-1246	Aripiprazole	Aripiprazole	REMEDYREPACK INC.	ANDA	Current
70518-1246	Aripiprazole	Aripiprazole	REMEDYREPACK INC.	ANDA	Current