Drug Approval Package
Elidel
(Pimecrolimus) Cream
Company: Novartis Pharmaceuticals Corporation
Application No.: 21-302
Approval Date: 12/13/2001
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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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Environmental Assessment (PDF)
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Pharmacology Review(s)
Part 1 (PDF) Part 5 (PDF) Part 2 (PDF) Part 6 (PDF) Part 3 (PDF) Part 7 (PDF) Part 4 (PDF) Part 8 (PDF) -
Statistical Review(s) (PDF)
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Microbiology Review(s) (PDF)
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Clinical Pharmacology Biopharmaceutics Review(s)
Part 1 (PDF)
Part 2 (PDF)
Date created: November 20, 2001
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