MedPath
FDA Product

Aripiprazole

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Aripiprazole

17856-0110

Regulatory Information

17856-0110

ANDA210479

C73584

January 7, 2021

USA

These highlights do not include all the information needed to use ARIPIPRAZOLE ORAL SOLUTION safely and effectively. See full prescribing information for ARIPIPRAZOLE ORAL SOLUTION. ARIPIPRAZOLE oral solution Initial U.S. Approval: 2002

Human Prescription Drug Label

2

Company Information

047437707

Active Ingredients

ARIPIPRAZOLE

Quantity: 1 mg in 1 mL

Code: 82VFR53I78

Class Code: ACTIB

EDETATE DISODIUM

Code: 7FLD91C86K

Class Code: IACT

FRUCTOSE

Code: 6YSS42VSEV

Class Code: IACT

GLYCERIN

Code: PDC6A3C0OX

Class Code: IACT

HYDROCHLORIC ACID

Code: QTT17582CB

Class Code: IACT

METHYLPARABEN

Code: A2I8C7HI9T

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

PROPYLPARABEN

Code: Z8IX2SC1OH

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

SODIUM HYDROXIDE

Code: 55X04QC32I

Class Code: IACT

BENZYL ALCOHOL

Code: LKG8494WBH

Class Code: IACT

SUCROSE

Code: C151H8M554

Class Code: IACT

Active Moieties

ARIPIPRAZOLE

Code: 82VFR53I78

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