Ganciclovir
These highlights do not include all the information needed to use GANCICLOVIR for Injection, USP safely and effectively. See full prescribing information for GANCICLOVIR for Injection, USP. Initial U.S. Approval: 1989
Approved
Approval ID
69017374-ac20-4b8c-86c7-d35907046dce
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 30, 2019
Manufacturers
FDA
Hainan Poly Pharm. Co., Ltd.
DUNS: 654561638
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code14335-030
Application NumberANDA204204
Product Classification
M
Marketing Category
C73584
G
Generic Name
ganciclovir sodium
Product Specifications
Route of AdministrationINTRAVENTRICULAR
Effective DateJanuary 30, 2019
FDA Product Classification
INGREDIENTS (3)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
GANCICLOVIR SODIUMActive
Quantity: 50 mg in 1 mL
Code: 02L083W284
Classification: ACTIM