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: 1989Rx only
Approved
Approval ID
b47f5d1c-36b8-49b6-a410-3b3f4661dde7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 21, 2022
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 608775388
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
GANCICLOVIR SODIUM
PRODUCT DETAILS
NDC Product Code63323-315
Application NumberANDA090658
Marketing CategoryC73584
Route of AdministrationINTRAVENOUS
Effective DateAugust 31, 2019
Generic NameGANCICLOVIR SODIUM
INGREDIENTS (3)
GANCICLOVIR SODIUMActive
Quantity: 500 mg in 10 mL
Code: 02L083W284
Classification: ACTIM
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT