Lifitegrast
These highlights do not include all the information needed to use LIFITEGRAST OPHTHALMIC SOLUTION safely and effectively. See full prescribing information for LIFITEGRAST OPHTHALMIC SOLUTION. LIFITEGRAST ophthalmic solution, for topical ophthalmic use Initial U.S. Approval: 2016
Approved
Approval ID
1d4b4b61-79da-4b6f-bb19-056d111bf400
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 13, 2023
Manufacturers
FDA
Aurobindo Pharma Limited
DUNS: 650082092
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 Code59651-450
Application NumberANDA215063
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lifitegrast
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateNovember 13, 2023
FDA Product Classification
INGREDIENTS (7)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
SODIUM THIOSULFATEInactive
Code: HX1032V43M
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
LIFITEGRASTActive
Quantity: 50 mg in 1 mL
Code: 038E5L962W
Classification: ACTIB