FDA NDA 209637, OZEMPIC, NOVO, 12/05/2017

Contents: Summary Basis of Approval (SBOA) of Ozempic (Semaglutide Injection), 2 mg/3 mL (0.68 mg/mL) (NDA 209637) held by Novo Nordisk Inc.

NDA: 209637
Company: NOVO
Drug Name: OZEMPIC
Active Ingredients: SEMAGLUTIDE
Strength: 2MG/3ML (0.68MG/ML)
Dosage Form/Route: SOLUTION;SUBCUTANEOUS
Action Date: 12/05/2017
Marketing Status: Prescription
Submission Classification: ORIG-1
Action Date: None

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