fomepizole
Fomepizole Injection Sterile Rx only .
Approved
Approval ID
82dc2920-af7f-4e43-9f6d-8877a71884cd
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 6, 2019
Manufacturers
FDA
American Regent, Inc.
DUNS: 002033710
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
fomepizole
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0517-0710
Application NumberANDA078368
Product Classification
M
Marketing Category
C73584
G
Generic Name
fomepizole
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 6, 2019
FDA Product Classification
INGREDIENTS (1)
FOMEPIZOLEActive
Quantity: 1 g in 1 mL
Code: 83LCM6L2BY
Classification: ACTIB