Xiidra
These highlights do not include all the information needed to use XIIDRA safely and effectively. See full prescribing information for XIIDRA. XIIDRA (lifitegrast ophthalmic solution), for topical ophthalmic useInitial U.S. Approval: 2016
Approved
Approval ID
8589d376-ac10-4ddb-9c53-2e0c8d5675c4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 2, 2023
Manufacturers
FDA
Novartis Pharmaceuticals Corporation
DUNS: 002147023
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lifitegrast
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0078-0911
Application NumberNDA208073
Product Classification
M
Marketing Category
C73594
G
Generic Name
Lifitegrast
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJuly 31, 2020
FDA Product Classification
INGREDIENTS (7)
SODIUM THIOSULFATEInactive
Code: HX1032V43M
Classification: IACT
LIFITEGRASTActive
Quantity: 50 mg in 1 mL
Code: 038E5L962W
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT