Omlonti
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
Approved
Approval ID
8e440b2c-fbe5-4c86-b7f3-3da00a5b2924
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 9, 2023
Manufacturers
FDA
Santen Incorporated
DUNS: 869321331
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
omidenepag isopropyl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65086-002
Application NumberNDA215092
Product Classification
M
Marketing Category
C73594
G
Generic Name
omidenepag isopropyl
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateOctober 9, 2023
FDA Product Classification
INGREDIENTS (10)
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
POLYOXYL 35 CASTOR OILInactive
Code: 6D4M1DAL6O
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
OMIDENEPAG ISOPROPYLActive
Quantity: 0.02 mg in 1 mL
Code: G0G0H52U6K
Classification: ACTIB