Ketorolac / Phenylephrine Ophthalmic Irrigation Solution

Brand(s)
Omidria
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Omeros Corporation (2015-06-26)
Oldest Current Product
2014-06-13
License(s)
NDA
RxNORM
OPHTHALMIC IRRIGATION SOLUTION\KETOROLAC:PHENYLEPHRINE
FDAOB
IRRIGATION\SOLUTION\KETOROLAC TROMETHAMINE: PHENYLEPHRINE HYDROCHLORIDE
SPL Active
INTRAOCULAR\INJECTION, SOLUTION, CONCENTRATE\KETOROLAC: PHENYLEPHRINE
SPL Moiety
INTRAOCULAR\INJECTION, SOLUTION, CONCENTRATE\KETOROLAC: PHENYLEPHRINE

product(s) by strength(s)

ketorolac 2.88 mg/ml / phenylephrine 10.16 mg/ml ophthalmic irrigation solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1622250600OmidriaNDAOmeros Corporation2014-06-13KETOROLAC, PHENYLEPHRINEINTRAOCULARINJECTION, SOLUTION, CONCENTRATENDA20538821470688-4e81-4ea5-ac38-f72e10552e7e

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA205388OMIDRIAOMEROS CORP2014-05-30p8173707, MAINTAINING PUPIL SIZE BY PREVENTING INTRAOPERATIVE MIOSIS AND REDUCING POSTOPERATIVE OCULAR PAIN
p9066856, SUBSTANCE
p8586633, SUBSTANCE
NEW PRODUCT [2017-05-30]NDA205388_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA205388_001RXKETOROLAC TROMETHAMINE (EQ 4.24MG BASE/ML), PHENYLEPHRINE HYDROCHLORIDE (EQ 12.4MG BASE/ML)IRRIGATIONSOLUTIONTrue2014-05-30OMIDRIA

patent(s)

#idexpiration dateapplication(s)
1p8173707 (view patent)2023-07-30NDA205388
2p8586633 (view patent)2023-07-30NDA205388
3p9066856 (view patent)2033-10-23NDA205388

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
121470688-4e81-4ea5-ac38-f72e10552e7e (view SPL)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 injection) 1% / 0.3% Initial U.S. Approval: 2014prescriptionHuman PrescriptionOmeros Corporation2015-06-2611622250600

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII