Elzonris
These highlights do not include all the information needed to use ELZONRISsafely and effectively. See full prescribing information for ELZONRIS. ELZONRIS (tagraxofusp-erzs) injection, for intravenous use Initial U.S. Approval: 2018
Approved
Approval ID
80eb1080-fe20-4af0-b2a5-a67999923fa8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 31, 2023
Manufacturers
FDA
Stemline Therapeutics, Inc.
DUNS: 139606136
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
tagraxofusp
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72187-0401
Application NumberBLA761116
Product Classification
M
Marketing Category
C73585
G
Generic Name
tagraxofusp
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateDecember 31, 2018
FDA Product Classification
INGREDIENTS (5)
TAGRAXOFUSPActive
Quantity: 1000 ug in 1 mL
Code: 8ZHS5657EH
Classification: ACTIB
SORBITOLInactive
Quantity: 50 mg in 1 mL
Code: 506T60A25R
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 4.38 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
TROMETHAMINEInactive
Quantity: 2.42 mg in 1 mL
Code: 023C2WHX2V
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT