Drug Approval Package

 Rozerem (Ramelteon) Tablets
Company:  Takeda Global Research
Application No.:  021782
Approval Date: 7/22/2005

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

• Medical Review(s) (PDF)  

• Chemistry Review(s) (PDF)  

• Pharmacology Review(s) (PDF)  

• Statistical Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) & Correspondence (PDF)  

Date created: October 202005

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