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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 205388

OMIDRIA (KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE)
EQ 0.3% BASE;EQ 1% BASE
Marketing Status: Prescription
Active Ingredient: KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE
Proprietary Name: OMIDRIA
Dosage Form; Route of Administration: SOLUTION; IRRIGATION
Strength: EQ 0.3% BASE;EQ 1% BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AT
Application Number: N205388
Product Number: 001
Approval Date: May 30, 2014
Applicant Holder Full Name: RAYNER SURGICAL INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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