FDA NDA 215866, MOUNJARO (AUTOINJECTOR), ELI LILLY AND CO, 05/13/2022

Content: Summary Basis of Approval documents for Mounjaro (tirzepatide) for prior approval supplement (S-002), approved on 7/28/2023, including review documents related to human factors testing of the tirzepatide vial and syringe.

NDA: 215866
Company: ELI LILLY AND CO
Drug Name: MOUNJARO (AUTOINJECTOR)
Active Ingredients: TIRZEPATIDE
Strength: 15MG/0.5ML (15MG/0.5ML)
Dosage Form/Route: SOLUTION;SUBCUTANEOUS
Action Date: 05/13/2022
Marketing Status: Prescription
Submission Classification: ORIG-1

156 Pages 

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