MedPath
FDA Product

Risperidone

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

Basic Information

Risperidone

17856-0380

Regulatory Information

17856-0380

ANDA091384

C73584

May 31, 2011

USA

These highlights do not include all the information needed to use Risperidone safely and effectively. see full prescribing information for Risperidone. Risperidone (Risperidone) SOLUTION for ORAL use. Initial U.S. Approval: 1993

HUMAN PRESCRIPTION DRUG LABEL

2

Company Information

047437707

Active Ingredients

RISPERIDONE

Quantity: 1 mg in 1 mL

Code: L6UH7ZF8HC

Class Code: ACTIB

BENZOIC ACID

Code: 8SKN0B0MIM

Class Code: IACT

WATER

Code: 059QF0KO0R

Class Code: IACT

Active Moieties

RISPERIDONE

Code: L6UH7ZF8HC

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