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
178a014b-92c7-44a7-abb8-95d89a2feb8f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 7, 2022
Manufacturers
FDA
Ajanta Pharma USA Inc.
DUNS: 557554156
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 Code27241-159
Application NumberANDA212890
Product Classification
M
Marketing Category
C73584
G
Generic Name
Valganciclovir hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 10, 2022
FDA Product Classification
INGREDIENTS (12)
VALGANCICLOVIR HYDROCHLORIDEActive
Quantity: 50 mg in 1 mL
Code: 4P3T9QF9NZ
Classification: ACTIR
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
MALTODEXTRINInactive
Code: 7CVR7L4A2D
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
ACACIAInactive
Code: 5C5403N26O
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
.ALPHA.-TOCOPHEROLInactive
Code: H4N855PNZ1
Classification: IACT
OCTENYLSUCCINIC ACIDInactive
Code: 12UZE4X73L
Classification: IACT