Memorandum/Reviews

• Approval Memorandum - Voluven, December 20, 2007
• Summary Based Approval (Clinical Pharmacology)
• CMC Review Memo
• NDA Review Memo (Mid-Cycle) (PDF - 1.7MB)
• Review Memo - PREA
• CMC Sections of the Original NDA - Voluven (PDF - 114KB)
• Final Review Memo for the Original NDA for 6% Hydroxylethyl Starch - Voluven (PDF - 87KB)
• Pharmacology Toxicology Review Memorandum - Voluven (PDF - 766KB)
• NDA Review Memo and Addendum - Voluven (PDF - 2.5MB)

Administrative Documents

• Officer/Employee List
• Filing Memo
• Categorical Exclusion under 21 CFR 25.31(c)
• Compliance Check
• Transmittal of Labels and Circulars (PDF - 67KB)
• Record of Telephone Conversation with Fresenius Kabi - 12/17/2007 and 12/18/2007
• Memo - Blood Products Advisory Committee

Correspondence

• Acknowledgment Letter
• Telecon with Fresenius Kabi - 12/14/2007
• Telecon with Fresenius Kabi - 11/28/2007
• Telecon with Fresenius Kabi - 11/29/2007
• Telecon with Fresenius Kabi - 11/30/2007
• Telecon with Fresenius Kabi - 10/31/2007
• Memorandum Telecon with Fresenius Kabi - 6/18/2007
• 10/5/2007 Fax
• 9/13/2007 Fax
• 9/4/2007 Fax
• 8/3/2007 Fax
• 6/29/2007 Fax
• 6/29/2007 Fax

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