Drug Approval Package
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Boniva (Ibandronate Sodium) Tablets
Company: Hoffmann-La Roche Inc.
Application No.: 21-455
Approval Date: 5/16/2003
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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)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Part 4 (PDF)
Part 5 (PDF) -
Correspondence (PDF)
Date created: July 02, 2003
Note: Documents in PDF format require the Adobe Acrobat Reader®.
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