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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208251

OTOVEL (CIPROFLOXACIN HYDROCHLORIDE; FLUOCINOLONE ACETONIDE)
EQ 0.3% BASE;0.025%
Marketing Status: Prescription
Active Ingredient: CIPROFLOXACIN HYDROCHLORIDE; FLUOCINOLONE ACETONIDE
Proprietary Name: OTOVEL
Dosage Form; Route of Administration: SOLUTION/DROPS; OTIC
Strength: EQ 0.3% BASE;0.025%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208251
Product Number: 001
Approval Date: Apr 29, 2016
Applicant Holder Full Name: LABORATORIOS SALVAT SA
Marketing Status:  Prescription
Patent and Exclusivity Information
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