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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 019079

FLAREX (FLUOROMETHOLONE ACETATE)
0.1%
Marketing Status: Prescription
Active Ingredient: FLUOROMETHOLONE ACETATE
Proprietary Name: FLAREX
Dosage Form; Route of Administration: SUSPENSION/DROPS; OPHTHALMIC
Strength: 0.1%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N019079
Product Number: 001
Approval Date: Feb 11, 1986
Applicant Holder Full Name: HARROW EYE LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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