Manufacturing Establishments5
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
CoreRx Pharmaceuticals, Inc.
USWM, LLC
780516717
SGS North America
USWM, LLC
808308303
Aphena Pharma Solutions - TN, LLC
USWM, LLC
118348161
ScinoPharm Taiwan Ltd.
USWM, LLC
657484726
Quality Chemical Laboratories
USWM, LLC
071344167
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
iwilfin
Product Details
NDC Product Code
78670-150Application Number
NDA215500Marketing Category
NDA (C73594)Route of Administration
ORALEffective Date
December 21, 2023EflornithineActive
Code: 4NH22NDW9HClass: ACTIRQuantity: 250 mg in 1 1
microcrystalline celluloseInactive
Code: OP1R32D61UClass: IACT
silicon dioxideInactive
Code: ETJ7Z6XBU4Class: IACT
magnesium stearateInactive
Code: 70097M6I30Class: IACT