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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208552

RHOFADE (OXYMETAZOLINE HYDROCHLORIDE)
1%
Marketing Status: Prescription
Active Ingredient: OXYMETAZOLINE HYDROCHLORIDE
Proprietary Name: RHOFADE
Dosage Form; Route of Administration: CREAM; TOPICAL
Strength: 1%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208552
Product Number: 001
Approval Date: Jan 18, 2017
Applicant Holder Full Name: EPI HEALTH LLC
Marketing Status:  Prescription
Patent and Exclusivity Information
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