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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 213872

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ASTEPRO ALLERGY (AZELASTINE HYDROCHLORIDE)
0.2055MG/SPRAY
Marketing Status: Over-the-counter
Active Ingredient: AZELASTINE HYDROCHLORIDE
Proprietary Name: ASTEPRO ALLERGY
Dosage Form; Route of Administration: SPRAY, METERED; NASAL
Strength: 0.2055MG/SPRAY
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N213872
Product Number: 001
Approval Date: Jun 17, 2021
Applicant Holder Full Name: BAYER HEALTHCARE CONSUMER CARE
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
CHILDREN'S ASTEPRO ALLERGY (AZELASTINE HYDROCHLORIDE)
0.2055MG/SPRAY
Marketing Status: Over-the-counter
Active Ingredient: AZELASTINE HYDROCHLORIDE
Proprietary Name: CHILDREN'S ASTEPRO ALLERGY
Dosage Form; Route of Administration: SPRAY, METERED; NASAL
Strength: 0.2055MG/SPRAY
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N213872
Product Number: 002
Approval Date: Jun 17, 2021
Applicant Holder Full Name: BAYER HEALTHCARE CONSUMER CARE
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
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