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
NDC Product Code82667-900
Application NumberNDA217469
Marketing CategoryC73594
Route of AdministrationOPHTHALMIC
Effective DateNovember 21, 2023
Generic Namecyclosporine ophthalmic solution
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