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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 216675

MIEBO (PERFLUOROHEXYLOCTANE)
1.338GM/ML
Marketing Status: Prescription
Active Ingredient: PERFLUOROHEXYLOCTANE
Proprietary Name: MIEBO
Dosage Form; Route of Administration: SOLUTION/DROPS; OPHTHALMIC
Strength: 1.338GM/ML
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216675
Product Number: 001
Approval Date: May 18, 2023
Applicant Holder Full Name: BAUSCH AND LOMB INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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