Drug Approval Package

 Twisthaler (Mometasone Furoate) Inhalation Powder
Company:  Schering Corporation
Application No.:  021067
Approval Date: 03/30/2005

• Approval Letter(s) (PDF)

• Approvable 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: July 052006

Back to Top    Drugs@FDA

Note: Documents in PDF format require the Adobe Acrobat Reader®.