Visudyne
VISUDYNE (VERTEPORFIN FOR INJECTION)
Approved
Approval ID
31512723-9ff0-4e18-aa3a-55ab833038c6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 7, 2010
Manufacturers
FDA
QLT Ophthalmics, Inc.
DUNS: 832856848
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
verteporfin for injection
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50236-001
Application NumberNDA021119
Product Classification
M
Marketing Category
C73594
G
Generic Name
verteporfin for injection
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateJanuary 11, 2010
FDA Product Classification
INGREDIENTS (4)
ASCORBYL PALMITATEInactive
Code: QN83US2B0N
Classification: IACT
VERTEPORFINActive
Quantity: 15 mg in 1 1
Code: 0X9PA28K43
Classification: ACTIB
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT