Valganciclovir
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
cc6c4939-7908-439c-b1b8-6b52e826c7a5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 13, 2023
Manufacturers
FDA
Florida Pharmaceutical Products, LLC
DUNS: 084014259
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Valganciclovir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71921-210
Application NumberANDA216317
Product Classification
M
Marketing Category
C73584
G
Generic Name
Valganciclovir
Product Specifications
Route of AdministrationORAL
Effective DateJune 20, 2023
FDA Product Classification
INGREDIENTS (6)
VALGANCICLOVIRActive
Quantity: 50 mg in 1 mL
Code: GCU97FKN3R
Classification: ACTIB
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT