Drug Approval Package
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Rhinocort
Aqua (Budesonide) Nasal Spray
Company: AstraZeneca
Application No.: 20-746
Approval Date: 10/01/1999
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Approval Letter(s) (PDF)
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Printed Labeling (PDF)
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Medical Review(s)
Part 1 (PDF) Part 2 (PDF) -
Chemistry Review(s) (PDF)
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Environmental Assessment (PDF)
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Statistical Review(s) (PDF)
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Microbiology Review(s) (PDF)
Date created: June 19, 2001
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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