Drug Approval Package
Spiriva HandiHaler (Tiotropium
Bromide) Inhalation Powder
Company: Boehringer Ingelheim
Application No.: 021395
Approval Date: 1/30/2004
-
Approval Letter(s) (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
Note: Documents in PDF format require the Adobe Acrobat Reader®.