Drug Approval Package
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Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) Injectiion
Company: Hoffman La-Roche
Application No.: 125164
Approval Date: 11/14/2007
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Approval Letter(s) (PDF)
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Printed Labeling (PDF)
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Officer/Employee List (PDF)
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Office Director Memo (PDF)
- Medical Review(s)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF) -
Chemistry Review(s) (PDF)
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Statistical Review(s) (PDF)
- Proprietary Name Review(s) (PDF)
- Administrative
Document(s) & Correspondence
Part 1 (PDF)
Part 2 (PDF)
Date created: March 17, 2008
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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