Drug Approval Package
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Alvesco (Ciclesonide) Inhalation Aerosol
Company: Nycomed US Inc.
Application No.: 021658
Approval Date: 1/10/2008
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
- Approval Letter(s) (PDF)
- Approvable Letter (PDF)
- Summary Review (PDF)
- Office Director Memo (PDF)
- Cross Discipline Team Leader Review (PDF)
- Printed Labeling (PDF)
- Medical Review(s) (PDF)
- Part 7 (PDF)
- Chemistry Review(s) (PDF)
- Pharmacology Review(s) (PDF)
- Statistical Review(s) (PDF)
- Microbiology Review(s) (PDF)
- Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
- Proprietary Name Review(s) (PDF)
- Administrative Document(s) & Correspondence (PDF)
Date created: July 20, 2009
Vision impaired people having problems accessing certain pages of a PDF file may call (301) 796-3634 for assistance.
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