Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208032

KOVANAZE (OXYMETAZOLINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE)
0.1MG/SPRAY;6MG/SPRAY Marketing Status: Prescription

Active Ingredient: OXYMETAZOLINE HYDROCHLORIDE; TETRACAINE HYDROCHLORIDE
Proprietary Name: KOVANAZE
Dosage Form; Route of Administration: SPRAY, METERED; NASAL
Strength: 0.1MG/SPRAY;6MG/SPRAY
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208032
Product Number: 001
Approval Date: Jun 29, 2016
Applicant Holder Full Name: ST RENATUS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

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