Drug Approval Package
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Stalevo
50, 100 & 150 (carbidopa/ levodopa/ entacapone) Tablets
Company: Orion
Pharma, Inc.
Application No.: 021485
Approval Date: 6/11/2003
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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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Clinical Pharmacology Biopharmaceutics Review(s)
Part 1 (PDF)
Part 2 (PDF) -
Correspondence (PDF)
Date created: March 242004
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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