Drug Approval Package
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Bethkis (tobramycin 300 mg/4mL inhalation solution)
Company: Chiesi Pharmaceuticals, Inc.
Application No.: 201820
Approval Date: 10/12/2012
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
- Approval Letter(s) (PDF)
- Summary Review (PDF)
- Officer/Employee List (PDF)
- Cross Discipline Team Leader Review (PDF)
- Printed Labeling (PDF)
- Medical Review(s) (PDF)
- Microbiology Review (PDF)
- Chemistry Review(s) (PDF)
- Pharmacology Review(s) (PDF)
- Proprietary Name Review(s) (PDF)
- Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
- Statistical Review (PDF)
- Other Action Letter(s) (PDF)
- Other Review(s) (PDF)
- Administrative Document(s) & Correspondence (PDF)
Date created: September 3, 2013
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