Afrezza (insulin human) Inhalation Powder

Company:  MannKind Corporation
Application No.:  022472
Approval Date: 06/27/2014

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• Approval Letter(s) (PDF)
• Other Action Letter (s) (PDF)
• Printed Labeling (PDF)
• REMS (PDF)
• Summary Review (PDF)
• Officer/Employee List (PDF)
• Cross Discipline Team Leader Review (PDF)
• Medical Review(s) (PDF)
• Chemistry Review(s) (PDF)
• Pharmacology Review(s) (PDF)
• Statistical Review(s) (PDF)
• Microbiology Review(s) (PDF)
• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
• Risk Assessment and Risk Mitigation Review(s) (PDF)
• Proprietary Name Review(s) (PDF)
• Other Review(s) (PDF)
• Administrative Document(s) & Correspondence (PDF)

 

Date created: May 28, 2015

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