Risperidone
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
Approved
Approval ID
dae5ec58-85c1-4503-a6b8-56696dd1e6fc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 31, 2011
Manufacturers
FDA
Atlantic Biologicals Corps
DUNS: 047437707
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 Code17856-0380
Application NumberANDA091384
Product Classification
M
Marketing Category
C73584
G
Generic Name
Risperidone
Product Specifications
Route of AdministrationORAL
Effective DateMay 31, 2011
FDA Product Classification
INGREDIENTS (3)
RISPERIDONEActive
Quantity: 1 mg in 1 mL
Code: L6UH7ZF8HC
Classification: ACTIB
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT