FDA NDA · NDA205388

OMIDRIA

phenylephrine and ketorolac

Sponsor: RAYNER SURGICAL

APPLICATION

NDA205388

TYPE

NDA

ORIGINAL APPROVAL

2014-05-30

LATEST ACTION

2017-12-08

ROUTE

INTRAOCULAR, IRRIGATION

DOSAGE FORM

SOLUTION

MARKETING STATUS

Prescription

Products

OMIDRIA · ReferencePrescription

KETOROLAC TROMETHAMINE EQ 0.3% BASE, PHENYLEPHRINE HYDROCHLORIDE EQ 1% BASE · SOLUTION · IRRIGATION

2017-12-08Efficacy · Supplement 6 · priority — Label ↗AP

2016-10-27Manufacturing (CMC) · Supplement 4AP

2016-07-08Manufacturing (CMC) · Supplement 3 · standardAP

2016-01-15Manufacturing (CMC) · Supplement 2 · standardAP

2015-05-21Manufacturing (CMC) · Supplement 1 · standard — Label ↗AP

2014-05-30Type 4 - New Combination · Original · standard — Label ↗AP

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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