Drug Approval Package
Spiriva HandiHaler (Tiotropium
Bromide) Inhalation Powder
Company: Boehringer Ingelheim
Application No.: 021395
Approval Date: 1/30/2004
(PDF)
Printed Labeling (PDF)
Medical Review(s)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Part 4 (PDF)
Part 5 (PDF)
Part 6 (PDF)
Chemistry Review(s) (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) (PDF)
Clinical
Pharmacology Biopharmaceutics Review(s)
Part 1 (PDF)
Part 2 (PDF)
Correspondence (PDF)
Date created: May 062004
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