Drug Approval Package
Synera (Lidocaine and Tertracaine) Topical Patch
Company: Zars, Inc.
Application No.: 021623
Approval Date: 06/23/2005
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Approval Letter(s) (PDF)
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Approvable Letter (PDF)
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Printed Labeling (PDF)
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Medical Review(s)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Part 4 (PDF) -
Chemistry Review(s) (PDF)
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Statistical Review(s) (PDF)
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Microbiology Review(s) (PDF)
Date created: March 14, 2008
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