Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 203313

RYZODEG 70/30 (INSULIN ASPART; INSULIN DEGLUDEC)
90 UNITS/3ML;210 UNITS/3ML (30 UNITS/ML;70 UNITS/ML) Marketing Status: Prescription

Active Ingredient: INSULIN ASPART; INSULIN DEGLUDEC
Proprietary Name: RYZODEG 70/30
Dosage Form; Route of Administration: SOLUTION; SUBCUTANEOUS
Strength: 90 UNITS/3ML;210 UNITS/3ML (30 UNITS/ML;70 UNITS/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N203313
Product Number: 001
Approval Date: Sep 25, 2015
Applicant Holder Full Name: NOVO NORDISK INC
Marketing Status:  Prescription
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