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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208294

BEVESPI AEROSPHERE (FORMOTEROL FUMARATE; GLYCOPYRROLATE)
0.0048MG/INH;0.0090MG/INH
Marketing Status: Prescription
Active Ingredient: FORMOTEROL FUMARATE; GLYCOPYRROLATE
Proprietary Name: BEVESPI AEROSPHERE
Dosage Form; Route of Administration: AEROSOL, METERED; INHALATION
Strength: 0.0048MG/INH;0.0090MG/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208294
Product Number: 001
Approval Date: Apr 25, 2016
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status:  Prescription
Patent and Exclusivity Information
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