Drug Approval Package
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Pulmicort
Turbuhaler (Budesomide Powder for Oral Inhalation)
Company: Astra USA, Inc.
Application No.: 20-441/S002
Approval Date: 10/9/1998
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Approval Letter(s) (PDF)
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Printed Labeling (PDF)
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Medical Review(s) (PDF)
- Pharmacology Review(s) (PDF)
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Statistical Review(s) (PDF)
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Correspondence (PDF)
Date created: January 24, 2006
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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