Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 203314

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TRESIBA (INSULIN DEGLUDEC)
300 UNITS/3ML (100 UNITS/ML) Marketing Status: Prescription

Active Ingredient: INSULIN DEGLUDEC
Proprietary Name: TRESIBA
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 300 UNITS/3ML (100 UNITS/ML)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N203314
Product Number: 001
Approval Date: Sep 25, 2015
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status:  Prescription
Patent and Exclusivity Information

TRESIBA (INSULIN DEGLUDEC)
600 UNITS/3ML (200 UNITS/ML) Marketing Status: Prescription

Active Ingredient: INSULIN DEGLUDEC
Proprietary Name: TRESIBA
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 600 UNITS/3ML (200 UNITS/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N203314
Product Number: 002
Approval Date: Sep 25, 2015
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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