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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 209210

BYDUREON BCISE (EXENATIDE SYNTHETIC)
2MG/0.85ML (2MG/0.85ML)
Marketing Status: Prescription
Active Ingredient: EXENATIDE SYNTHETIC
Proprietary Name: BYDUREON BCISE
Dosage Form; Route of Administration: SUSPENSION, EXTENDED RELEASE; SUBCUTANEOUS
Strength: 2MG/0.85ML (2MG/0.85ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209210
Product Number: 001
Approval Date: Oct 20, 2017
Applicant Holder Full Name: ASTRAZENECA AB
Marketing Status:  Prescription
Patent and Exclusivity Information
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