Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 209196

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ADMELOG (INSULIN LISPRO)
1000 UNITS/10ML (100 UNITS/ML) Marketing Status: Prescription

Active Ingredient: INSULIN LISPRO
Proprietary Name: ADMELOG
Dosage Form; Route of Administration: SOLUTION; IV (INFUSION), SUBCUTANEOUS
Strength: 1000 UNITS/10ML (100 UNITS/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N209196
Product Number: 001
Approval Date: Dec 11, 2017
Applicant Holder Full Name: SANOFI-AVENTIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

ADMELOG SOLOSTAR (INSULIN LISPRO)
300 UNITS/3ML (100 UNITS/ML) Marketing Status: Prescription

Active Ingredient: INSULIN LISPRO
Proprietary Name: ADMELOG SOLOSTAR
Dosage Form; Route of Administration: SOLUTION; IV (INFUSION), SUBCUTANEOUS
Strength: 300 UNITS/3ML (100 UNITS/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N209196
Product Number: 002
Approval Date: Dec 11, 2017
Applicant Holder Full Name: SANOFI-AVENTIS US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

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