iwilfin
These highlights do not include all the information needed to use IWILFIN® safely and effectively. See full prescribing information for IWILFIN. IWILFIN® (eflornithine) tablets, for oral use Initial U.S. Approval: 2023
Approved
Approval ID
6716d8cc-66e6-4cee-935c-ccb85ed984f5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 21, 2023
Manufacturers
FDA
USWM, LLC
DUNS: 117542566
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
EFLORNITHINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code78670-150
Application NumberNDA215500
Product Classification
M
Marketing Category
C73594
G
Generic Name
EFLORNITHINE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateDecember 21, 2023
FDA Product Classification
INGREDIENTS (4)
EFLORNITHINE HYDROCHLORIDEActive
Quantity: 250 mg in 1 1
Code: 4NH22NDW9H
Classification: ACTIR
microcrystalline celluloseInactive
Code: OP1R32D61U
Classification: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT