RISPERIDONE
These highlights do not include all the information needed to use risperidone oral solution safely and effectively. See full prescribing information for risperidone oral solution. Risperidone Oral Solution for Oral use. Initial U.S. approval:1993
Approved
Approval ID
f9e04064-6b9e-4209-8149-8761f29d1cec
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 14, 2009
Manufacturers
FDA
WOCKHARDT USA LLC.
DUNS: 170508365
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
RISPERIDONE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code64679-692
Application NumberANDA078744
Product Classification
M
Marketing Category
C73584
G
Generic Name
RISPERIDONE
Product Specifications
Route of AdministrationORAL
Effective DateOctober 14, 2009
FDA Product Classification
INGREDIENTS (1)
RISPERIDONEActive
Quantity: 1 mg in 1 mL
Code: L6UH7ZF8HC
Classification: ACTIB