PERSERIS
These highlights do not include all the information needed to use PERSERIS safely and effectively. See full prescribing information for PERSERIS. PERSERIS (risperidone) for extended-release injectable suspension, for subcutaneous use.Initial U.S. Approval: 1993
Approved
Approval ID
a4f21b1a-5691-4b14-a56d-651962d06f39
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 15, 2023
Manufacturers
FDA
Indivior Inc.
DUNS: 797408549
Products 2
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 Code12496-0120
Application NumberNDA210655
Product Classification
M
Marketing Category
C73594
G
Generic Name
Risperidone
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJuly 31, 2018
FDA Product Classification
Risperidone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code12496-0090
Application NumberNDA210655
Product Classification
M
Marketing Category
C73594
G
Generic Name
Risperidone
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateJuly 31, 2018
FDA Product Classification