Drug Approval Package
Foradil
(Formolterol Fumarate Inhalation) Aerolizer
Company: Novartis
Application No.: 20-831
Approval Date: 2/16/2001
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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 5 (PDF) Part 2 (PDF) Part 6 (PDF) Part 3 (PDF) Part 7 (PDF) Part 4 (PDF) Part 8 (PDF) -
Chemistry Review(s)
Part 1 (PDF) Part 2 (PDF) -
Pharmacology Review(s)
Part 1 (PDF) Part 2 (PDF) Part 3 (PDF) Part 4 (PDF) Part 5 (PDF) Part 6 (PDF) -
Statistical Review(s)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Part 4 (PDF)
Part 5 (PDF) -
Microbiology Review(s) (PDF)
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Clinical Pharmacology Biopharmaceutics Review(s)
Part 1 (PDF)
Part 2 (PDF) -
Administrative Document(s)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Part 4 (PDF) -
Correspondence
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Part 4 (PDF)
Part 5 (PDF)
Date created: May 15, 2001
Note: Documents in PDF format require the Adobe Acrobat Reader®.