Fomepizole
Fomepizole Injection
Approved
Approval ID
911312e2-3a7c-4c97-88a8-b8d92cd12923
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 15, 2021
Manufacturers
FDA
Mylan Institutional LLC
DUNS: 790384502
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 Code67457-211
Application NumberANDA078639
Product Classification
M
Marketing Category
C73584
G
Generic Name
Fomepizole
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateAugust 15, 2018
FDA Product Classification
INGREDIENTS (1)
FomepizoleActive
Quantity: 1 g in 1 mL
Code: 83LCM6L2BY
Classification: ACTIB