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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 210897

BUDESONIDE (BUDESONIDE)
0.5MG/2ML
Marketing Status: Prescription
Active Ingredient: BUDESONIDE
Proprietary Name: BUDESONIDE
Dosage Form; Route of Administration: SUSPENSION; INHALATION
Strength: 0.5MG/2ML
Reference Listed Drug: No
Reference Standard: No
TE Code: AN
Application Number: A210897
Product Number: 001
Approval Date: Nov 9, 2018
Applicant Holder Full Name: LUPIN INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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