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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 078949

BUDESONIDE (BUDESONIDE)
0.032MG/SPRAY
Marketing Status: Over-the-counter
Active Ingredient: BUDESONIDE
Proprietary Name: BUDESONIDE
Dosage Form; Route of Administration: SPRAY, METERED; NASAL
Strength: 0.032MG/SPRAY
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A078949
Product Number: 002
Approval Date: Nov 20, 2015
Applicant Holder Full Name: APOTEX INC RICHMOND HILL
Marketing Status:  Over-the-counter
Patent and Exclusivity Information
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