valganciclovir hydrochloride
These highlights do not include all the information needed to use VALGANCICLOVIR FOR ORAL SOLUTION safely and effectively. See full prescribing information for VALGANCICLOVIR FOR ORAL SOLUTION. VALGANCICLOVIR for oral solution Initial U.S. Approval: 2001
Approved
Approval ID
614ff447-7e5f-4ea6-ba85-ec1f6497b360
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 29, 2022
Manufacturers
FDA
Novadoz Pharmaceuticals LLC
DUNS: 081109687
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
valganciclovir hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72205-019
Application NumberANDA210169
Product Classification
M
Marketing Category
C73584
G
Generic Name
valganciclovir hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 14, 2022
FDA Product Classification
INGREDIENTS (6)
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
VALGANCICLOVIR HYDROCHLORIDEActive
Quantity: 50 mg in 1 mL
Code: 4P3T9QF9NZ
Classification: ACTIR
FUMARIC ACIDInactive
Code: 88XHZ13131
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT