Drug Approval Package

 Remeron SolTab (Mirtazapine) Orally Disintegrating Tablets
Company:  Organon Inc.
Application No.:  21-208
Approval Date: 1/12/01

• Approval Letter(s) (PDF)  

• Printed Labeling (PDF)  

• Medical Review(s) (PDF)  

• Chemistry Review(s) (PDF)  

• Pharmacology Review(s) (PDF)  

• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)  

• Administrative Document(s) & Correspondence 
  Part 1 (PDF)  
  Part 2 (PDF)

Date created: April 29, 2002

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