Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 208471

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ADLYXIN (LIXISENATIDE)
0.15MG/3ML (0.05MG/ML) Marketing Status: Prescription

Active Ingredient: LIXISENATIDE
Proprietary Name: ADLYXIN
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 0.15MG/3ML (0.05MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208471
Product Number: 001
Approval Date: Jul 27, 2016
Applicant Holder Full Name: SANOFI-AVENTIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

ADLYXIN (LIXISENATIDE)
0.3MG/3ML (0.1MG/ML) Marketing Status: Prescription

Active Ingredient: LIXISENATIDE
Proprietary Name: ADLYXIN
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 0.3MG/3ML (0.1MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N208471
Product Number: 002
Approval Date: Jul 27, 2016
Applicant Holder Full Name: SANOFI-AVENTIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

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