phenylephrine and ketorolac

FDA Drug Profile — Omidria

phenylephrine and ketorolac is listed in the FDA National Drug Code directory with 4 NDC codes, marketed under brand name including Omidria. Available dosage form: injection, solution, concentrate.

Drug Details

Generic Name
phenylephrine and ketorolac
Brand Names
Omidria
Application Number
NDA205388
Sponsor
Patheon Manufacturing Services LLC
NDC Codes
4
Dosage Forms
INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAOCULAR
Active Ingredients
PHENYLEPHRINE, KETOROLAC

Indications and Usage

1 INDICATIONS AND USAGE Omidria ® is added to an ocular irrigating solution used during cataract surgery or intraocular lens replacement and is indicated for maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain. OMIDRIA is an alpha 1-adrenergic receptor agonist and nonselective cyclooxygenase inhibitor indicated for: Maintaining pupil size by preventing intraoperative miosis ( 1 ) Reducing postoperative pain ( 1 ) OMIDRIA is added to an ocular irrigating solution used during cataract surgery or intraocular lens replacement.