Application 078614

Type: ANDA
Sponsor: SUN PHARMA GLOBAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ARIPIPRAZOLE	ARIPIPRAZOLE	TABLET; ORAL	5MG	No	No
002	ARIPIPRAZOLE	ARIPIPRAZOLE	TABLET; ORAL	10MG	No	No
003	ARIPIPRAZOLE	ARIPIPRAZOLE	TABLET; ORAL	15MG	No	No
004	ARIPIPRAZOLE	ARIPIPRAZOLE	TABLET; ORAL	20MG	No	No
005	ARIPIPRAZOLE	ARIPIPRAZOLE	TABLET; ORAL	30MG	No	No

Source provenance: Browse the complete Orange Book source catalog.

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 6 of 7 · 121 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	96172aa4-9e13-4eca-83d5-85a88c1782d3	2024-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
ARIPIPRAZOLE	ARIPIPRAZOLE	A-S Medication Solutions	db6fc74e-4989-464d-9c19-a5b7a541fd46	2024-03-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ARIPIPRAZOLE generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Camber Pharmaceuticals, Inc.	2d8d574b-fbf4-4d2c-a37c-25556ecbf1aa	2024-02-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	fd2fa4da-2ee9-4965-b1f8-ce1c8b73ba93	2023-11-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Proficient Rx LP	fbd81df7-8482-493e-bfc5-a3352f466b9e	2023-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	NorthStar RxLLC	f87dbfe4-5417-47c9-a97f-d246cfc10023	2023-08-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	SQUARE PHARMACEUTICALS LIMITED	0f9b1fd8-a648-45c9-8655-14de07439f34	2023-07-02		Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	XLCare Pharmaceuticals, Inc.	0a6fa113-6bb2-4f88-af07-ce0914c98ff2	2023-06-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	ScieGen Pharmaceuticals Inc	a7d9d5d1-25ba-4f4e-a990-398c0bf09c7e	2023-02-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Alembic Pharmaceuticals Limited	4f1691a8-724e-430d-9bab-27b59ef9bd4e	2023-01-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Alembic Pharmaceuticals Limited	793fc904-2f11-4f97-a0ac-4d6910cac0f9	2023-01-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	XLCare Pharmaceuticals, Inc.	b284b294-40a0-4ccd-b7b7-b61267cd4e76	2023-01-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
ARIPIPRAZOLE	ARIPIPRAZOLE	A-S Medication Solutions	aaf7dc7e-04f3-442b-86d7-5f54d17d102c	2022-09-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: ARIPIPRAZOLE generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	NCS HealthCare of KY, LLC dba Vangard Labs	8da99c93-613e-4b78-9f91-3efc2dea194d	2022-08-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Proficient Rx LP	19a3c2f2-11eb-4ec9-ac38-134168bdf99c	2022-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Proficient Rx LP	11202c0a-7401-41c9-b1e7-d93739fcd36f	2022-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Dr.Reddys Laboratories Inc	0aa7e178-456a-4942-93aa-9ec18a58939f	2020-06-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	ScieGen Pharmaceuticals Inc	95954ba3-e838-4dd7-aef1-c51ac6aff76b	2020-05-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Proficient Rx LP	dbdc8fbe-c75f-4f17-a2cd-9f23802dcc5d	2019-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Aripiprazole generic name: ARIPIPRAZOLE
Aripiprazole	ARIPIPRAZOLE	Exelan Pharmaceuticals, Inc.	705190bf-9f9d-4183-a56b-4eeafeacde59	2018-12-28	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.