Drug Approval Package
Striant (Testosterone Buccal
System) Mucoadhesive
Company: Columbia Laboratories, Inc.
Application No.: 021543
Approval Date: 6/19/2003
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Approval Letter(s) (PDF)
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Printed Labeling (PDF)
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Medical Review(s) (PDF)
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Chemistry Review(s) (PDF)
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Pharmacology Review(s) (PDF)
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Statistical Review(s) (PDF)
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Microbiology Review(s) (PDF)
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Administrative Document(s) & Correspondence
Part 1 (PDF)
Part 2 (PDF)
Date created: October 262004
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