GANCICLOVIR
These highlights do not include all the information needed to use GANCICLOVIR INJECTION safely and effectively. See full prescribing information for GANCICLOVIR INJECTION. GANCICLOVIR INJECTION, for intravenous useInitial U.S. Approval: 1989
Approved
Approval ID
26361de8-39b5-4266-90f6-2b307940135d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 6, 2017
Manufacturers
FDA
EXELA PHARMA SCIENCES, LLC
DUNS: 831274399
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 Code51754-2500
Application NumberNDA209347
Product Classification
M
Marketing Category
C73594
G
Generic Name
GANCICLOVIR
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateSeptember 19, 2017
FDA Product Classification
INGREDIENTS (4)
GANCICLOVIRActive
Quantity: 2 mg in 1 mL
Code: P9G3CKZ4P5
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 8 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT