Drug Approval Package
MultiHance (Gadobenate
Dimeglumine) Injection & Injection In Pharamacy Bulk Package
Company: Bracco Diagnostics, Inc.
Application No.: 021357 & 021358
Approval Date: 11/23/2004
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Approval Letter(s) (PDF)
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Medical Review(s)
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Part 4 (PDF)
Part 5 (PDF)
Part 6 (PDF) -
Chemistry Review(s) (PDF)
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Pharmacology Review(s)
Part 1 (PDF)
Part 2 (PDF)
Part 4 (PDF) -
Statistical Review(s) (PDF)
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Microbiology Review(s) (PDF)
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Administrative Document(s) & Correspondence
Part 1 (PDF)
Part 2 (PDF)
Part 3 (PDF)
Part 4 (PDF)
Date created: March 282005
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