VEVYE
These highlights do not include all the information needed to use VEVYE safely and effectively. See full prescribing information for VEVYE. VEVYE (cyclosporine ophthalmic solution) 0.1%, for topical ophthalmic use Initial U.S. Approval: 1983
Approved
Approval ID
0a60fccf-7e1b-44fe-e063-6394a90aadd5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 21, 2023
Manufacturers
FDA
Harrow Eye, LLC
DUNS: 118526951
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
cyclosporine ophthalmic solution
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82667-900
Application NumberNDA217469
Product Classification
M
Marketing Category
C73594
G
Generic Name
cyclosporine ophthalmic solution
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateNovember 21, 2023
FDA Product Classification
INGREDIENTS (3)
ALCOHOLInactive
Quantity: 12.9 mg in 1 mL
Code: 3K9958V90M
Classification: IACT
CYCLOSPORINEActive
Quantity: 1 mg in 1 mL
Code: 83HN0GTJ6D
Classification: ACTIB
1,1,1,2,2,3,3,4,4-NONAFLUORONONANEInactive
Quantity: 1276.5 mg in 1 mL
Code: M4M23ZL2AD
Classification: IACT