Drug Approval Package
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Ertaczo (Sertaconazole
Nitrate) Cream
Company: Mylan Pharmaceuticals
Application No.: 021385
Approval Date: 12/10/2003
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Approval Letter(s) (PDF)
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Printed Labeling (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)
Date created: March 082004
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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