ILUMYA
These highlights do not include all the information needed to use ILUMYA safely and effectively. See full prescribing information for ILUMYA. ILUMYA (tildrakizumab-asmn) injection, for subcutaneous use Initial U.S. Approval: 2018
Approved
Approval ID
c6a322bb-51b9-4f0e-8642-62a9682ffcde
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 13, 2023
Manufacturers
FDA
Sun Pharmaceutical Industries, Inc.
DUNS: 146974886
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
tildrakizumab-asmn
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code47335-177
Application NumberBLA761067
Product Classification
M
Marketing Category
C73585
G
Generic Name
tildrakizumab-asmn
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateApril 17, 2023
FDA Product Classification
INGREDIENTS (6)
HISTIDINE MONOHYDROCHLORIDEInactive
Quantity: 1.42 mg in 1 mL
Code: 1D5Q932XM6
Classification: IACT
POLYSORBATE 80Inactive
Quantity: 0.5 mL in 1 mL
Code: 6OZP39ZG8H
Classification: IACT
SUCROSEInactive
Quantity: 70 mg in 1 mL
Code: C151H8M554
Classification: IACT
WATERInactive
Quantity: 1 mL in 1 mL
Code: 059QF0KO0R
Classification: IACT
TILDRAKIZUMABActive
Quantity: 100 mg in 1 mL
Code: DEW6X41BEK
Classification: ACTIB
HISTIDINEInactive
Quantity: 0.495 mg in 1 mL
Code: 4QD397987E
Classification: IACT