Drug Approval Package
Detrol
(tolterodine L-tartrate) Tablets
Company: Pharmacia & Upjohn Company
Application No.: 020771
Approval Date: 3/25/1998
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Approval Letter(s) (PDF) (259 KB)
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Medical Review(s)
Part 1 (PDF) (2.4 MB)
Part 2 (PDF) (2.3 MB) -
Chemistry Review(s) (PDF) (571 KB)
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Pharmacology Review(s)
Part 1 (PDF) (2 MB)
Part 2 (PDF) (2.3 MB) -
Statistical Review(s)
Part 1 (PDF) (2.9 MB)
Part 2 (PDF) (2.4 MB) -
Clinical Pharmacology Biopharmaceutics Review(s)
Part 1 (PDF) ( MB)
Part 2 (PDF) ( MB) -
Administrative Document(s)/Correspondence (PDF) (1.7 MB)
Date created: September 10, 2001
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