Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 207712

AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE (AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE)
EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY
Marketing Status: Prescription
Active Ingredient: AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE
Proprietary Name: AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE
Dosage Form; Route of Administration: SPRAY, METERED; NASAL
Strength: EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A207712
Product Number: 001
Approval Date: Apr 28, 2017
Applicant Holder Full Name: APOTEX INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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