Omidria
These highlights do not include all the information needed to use OMIDRIA safely and effectively. See full prescribing information for OMIDRIA. OMIDRIA (phenylephrine and ketorolac intraocular solution) 1% / 0.3%, for addition to ocular irrigating solution Initial U.S. Approval: 2014
Approved
Approval ID
21470688-4e81-4ea5-ac38-f72e10552e7e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 14, 2022
Manufacturers
FDA
Omeros Corporation
DUNS: 033364923
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
phenylephrine and ketorolac
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code62225-600
Application NumberNDA205388
Product Classification
M
Marketing Category
C73594
G
Generic Name
phenylephrine and ketorolac
Product Specifications
Route of AdministrationINTRAOCULAR
Effective DateDecember 14, 2022
FDA Product Classification
INGREDIENTS (5)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENYLEPHRINEActive
Quantity: 10.16 mg in 1 mL
Code: 1WS297W6MV
Classification: ACTIB
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
KETOROLACActive
Quantity: 2.88 mg in 1 mL
Code: YZI5105V0L
Classification: ACTIB