Ganciclovir
These highlights do not include all the information needed to use GANCICLOVIR FOR INJECTION safely and effectively. See full prescribing information for GANCICLOVIR FOR INJECTION. Ganciclovir for injection, for intravenous useInitial U.S. Approval: 1989
Approved
Approval ID
87afd103-6e64-444f-971d-0e732e9ae995
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 16, 2020
Manufacturers
FDA
Par Pharmaceutical, Inc.
DUNS: 092733690
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ganciclovir
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42023-173
Application NumberANDA204950
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ganciclovir
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 17, 2018
FDA Product Classification
INGREDIENTS (1)
GANCICLOVIR SODIUMActive
Quantity: 500 mg in 10 mL
Code: 02L083W284
Classification: ACTIM