Fanapt
These highlights do not include all the information needed to use FANAPT safely and effectively. See full prescribing information for FANAPT. FANAPT (iloperidone) tablets Initial U.S. Approval: 2009
Approved
Approval ID
69d63a08-1920-427a-a967-2ffea04fd974
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 28, 2017
Manufacturers
FDA
Avera McKennan Hospital
DUNS: 068647668
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
iloperidone
PRODUCT DETAILS
NDC Product Code69189-0665
Application NumberNDA022192
Marketing CategoryC73594
Route of AdministrationORAL
Effective DateMarch 28, 2017
Generic Nameiloperidone
INGREDIENTS (7)
ILOPERIDONEActive
Quantity: 4 mg in 1 1
Code: VPO7KJ050N
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT