Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021773

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BYETTA (EXENATIDE SYNTHETIC)
300MCG/1.2ML (250MCG/ML)
Marketing Status: Prescription

Active Ingredient: EXENATIDE SYNTHETIC
Proprietary Name: BYETTA
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 300MCG/1.2ML (250MCG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021773
Product Number: 001
Approval Date: Apr 28, 2005
Applicant Holder Full Name: ASTRAZENECA AB
Marketing Status:  Prescription
Patent and Exclusivity Information

BYETTA (EXENATIDE SYNTHETIC)
600MCG/2.4ML (250MCG/ML)
Marketing Status: Prescription

Active Ingredient: EXENATIDE SYNTHETIC
Proprietary Name: BYETTA
Dosage Form; Route of Administration: INJECTABLE; SUBCUTANEOUS
Strength: 600MCG/2.4ML (250MCG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021773
Product Number: 002
Approval Date: Apr 28, 2005
Applicant Holder Full Name: ASTRAZENECA AB
Marketing Status:  Prescription
Patent and Exclusivity Information