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FDA Approval

Omidria

CompanyOmeros Corporation (DUNS: 033364923)

Effective Date

December 14, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Phenylephrine(10.16 mg in 1 mL)

Ketorolac(2.88 mg in 1 mL)

Manufacturing Establishments (2)

Patheon Manufacturing Services LLC

Labeler

Omeros Corporation

DUNS Number

079415560

Labeler

Omeros Corporation

DUNS Number

093132819

Products (1)

Omidria

NDC Product Code

62225-600

Application Number

NDA205388

Marketing Category

NDA (C73594)

Route of Administration

INTRAOCULAR

Effective Date

December 14, 2022

Ingredients

WATERInactive

Code: 059QF0KO0RClass: IACT

PhenylephrineActive

Code: 1WS297W6MVClass: ACTIBQuantity: 10.16 mg in 1 mL

TRISODIUM CITRATE DIHYDRATEInactive

Code: B22547B95KClass: IACT

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QPClass: IACT

KetorolacActive

Code: YZI5105V0LClass: ACTIBQuantity: 2.88 mg in 1 mL

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