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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 203567

Marketing Status: Prescription
Active Ingredient: EFINACONAZOLE
Proprietary Name: JUBLIA
Dosage Form; Route of Administration: SOLUTION; TOPICAL
Strength: 10%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N203567
Product Number: 001
Approval Date: Jun 6, 2014
Applicant Holder Full Name: BAUSCH HEALTH AMERICAS INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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