Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022200

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BYDUREON (EXENATIDE SYNTHETIC)
2MG/VIAL Marketing Status: Prescription

Active Ingredient: EXENATIDE SYNTHETIC
Proprietary Name: BYDUREON
Dosage Form; Route of Administration: FOR SUSPENSION, EXTENDED RELEASE; SUBCUTANEOUS
Strength: 2MG/VIAL
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022200
Product Number: 001
Approval Date: Jan 27, 2012
Applicant Holder Full Name: ASTRAZENECA AB
Marketing Status:  Prescription
Patent and Exclusivity Information

BYDUREON PEN (EXENATIDE SYNTHETIC)
2MG Marketing Status: Prescription

Active Ingredient: EXENATIDE SYNTHETIC
Proprietary Name: BYDUREON PEN
Dosage Form; Route of Administration: FOR SUSPENSION, EXTENDED RELEASE; SUBCUTANEOUS
Strength: 2MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N022200
Product Number: 002
Approval Date: Feb 28, 2014
Applicant Holder Full Name: ASTRAZENECA AB
Marketing Status:  Prescription
Patent and Exclusivity Information

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