SAPHRIS
These highlights do not include all the information needed to use SAPHRIS (asenapine) safely and effectively. See full prescribing information for SAPHRIS.SAPHRIS (asenapine) sublingual tabletsInitial U.S. Approval: 2009
Approved
Approval ID
03c696e9-0e6b-4e5c-be0a-41416f8019be
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 16, 2011
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
ASENAPINE MALEATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-936
Application NumberNDA022117
Product Classification
M
Marketing Category
C73594
G
Generic Name
ASENAPINE MALEATE
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateFebruary 16, 2011
FDA Product Classification
INGREDIENTS (3)
ASENAPINE MALEATEActive
Quantity: 10 mg in 1 1
Code: CU9463U2E2
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT