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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 212122

BREZTRI AEROSPHERE (BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE)
0.16MG/INH;0.0048MG/INH;0.009MG/INH
Marketing Status: Prescription
Active Ingredient: BUDESONIDE; FORMOTEROL FUMARATE; GLYCOPYRROLATE
Proprietary Name: BREZTRI AEROSPHERE
Dosage Form; Route of Administration: AEROSOL, METERED; INHALATION
Strength: 0.16MG/INH;0.0048MG/INH;0.009MG/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N212122
Product Number: 001
Approval Date: Jul 23, 2020
Applicant Holder Full Name: ASTRAZENECA AB
Marketing Status:  Prescription
Patent and Exclusivity Information
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