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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 216579

SYMBICORT AEROSPHERE (BUDESONIDE; FORMOTEROL FUMARATE)
0.16MG/INH;0.0048MG/INH
Marketing Status: Prescription
Active Ingredient: BUDESONIDE; FORMOTEROL FUMARATE
Proprietary Name: SYMBICORT AEROSPHERE
Dosage Form; Route of Administration: AEROSOL, METERED; INHALATION
Strength: 0.16MG/INH;0.0048MG/INH
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216579
Product Number: 001
Approval Date: Apr 28, 2023
Applicant Holder Full Name: ASTRAZENECA PHARMACEUTICALS LP
Marketing Status:  Prescription
Patent and Exclusivity Information
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