Basic Information
Omlonti
65086-002
Regulatory Information
65086-002
NDA215092
C73594
October 9, 2023
USA
These highlights do not include all the information needed to use OMLONTI safely and effectively. See full prescribing information for OMLONTI . OMLONTI (omidenepag isopropyl ophthalmic solution) 0.002%, for topical ophthalmic use Initial U.S. Approval: 2022
HUMAN PRESCRIPTION DRUG LABEL
11
Company Information
869321331
Active Ingredients
Inactive Ingredients
TRISODIUM CITRATE DIHYDRATE
Code: B22547B95K
Class Code: IACT
CITRIC ACID MONOHYDRATE
Code: 2968PHW8QP
Class Code: IACT
POLYOXYL 35 CASTOR OIL
Code: 6D4M1DAL6O
Class Code: IACT
EDETATE DISODIUM
Code: 7FLD91C86K
Class Code: IACT
BENZALKONIUM CHLORIDE
Code: F5UM2KM3W7
Class Code: IACT
GLYCERIN
Code: PDC6A3C0OX
Class Code: IACT
SODIUM HYDROXIDE
Code: 55X04QC32I
Class Code: IACT
WATER
Code: 059QF0KO0R
Class Code: IACT
HYDROCHLORIC ACID
Code: QTT17582CB
Class Code: IACT
Active Moieties
OMIDENEPAG
Code: Z95F9F9LU4