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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 091409

AZELASTINE HYDROCHLORIDE (AZELASTINE HYDROCHLORIDE)
0.137MG/SPRAY
Marketing Status: Prescription
Active Ingredient: AZELASTINE HYDROCHLORIDE
Proprietary Name: AZELASTINE HYDROCHLORIDE
Dosage Form; Route of Administration: SPRAY, METERED; NASAL
Strength: 0.137MG/SPRAY
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A091409
Product Number: 001
Approval Date: Aug 14, 2017
Applicant Holder Full Name: ZYDUS PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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