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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 203491

Marketing Status: Prescription
Active Ingredient: NEPAFENAC
Proprietary Name: ILEVRO
Dosage Form; Route of Administration: SUSPENSION/DROPS; OPHTHALMIC
Strength: 0.3%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N203491
Product Number: 001
Approval Date: Oct 16, 2012
Applicant Holder Full Name: HARROW EYE LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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