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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 206307

XTORO (FINAFLOXACIN)
0.3%
Marketing Status: Discontinued
Active Ingredient: FINAFLOXACIN
Proprietary Name: XTORO
Dosage Form; Route of Administration: SUSPENSION/DROPS; OTIC
Strength: 0.3%
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N206307
Product Number: 001
Approval Date: Dec 17, 2014
Applicant Holder Full Name: FONSECA BIOSCIENCES LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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