Drug Approval Package
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Remeron SolTab (Mirtazapine) Orally Disintegrating
Tablets
Company: Organon Inc.
Application No.: 21-208
Approval Date: 1/12/01
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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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Administrative Document(s) & Correspondence
Part 1 (PDF)
Part 2 (PDF)
Date created: April 29, 2002
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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