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 7 of 7 · 121 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ARIPIPRAZOLE	ARIPIPRAZOLE	Camber Pharmaceuticals, Inc.	3718e585-06b9-40fd-a3eb-18b6497a4235	2017-08-08	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.