Eulexin
EULEXINTM (flutamide) CAPSULES USP
Approved
Approval ID
56b6ba36-9b49-4422-a2a4-7bfa0d941a5d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 13, 2022
Manufacturers
FDA
Waylis Therapeutics LLC
DUNS: 117678921
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Flutamide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code80725-600
Application NumberANDA075298
Product Classification
M
Marketing Category
C73584
G
Generic Name
Flutamide
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 13, 2022
FDA Product Classification
INGREDIENTS (1)
FLUTAMIDEActive
Quantity: 125 mg in 1 1
Code: 76W6J0943E
Classification: ACTIB