Approval History, Letters, Reviews and Related Documents - RECOTHROM

Proper Name: Thrombin, topical (Recombinant)
Tradename: RECOTHROM
Manufacturer: ZymoGenetics, Inc, License #1758
STN: 125248/0
Approval Date: January 17, 2008

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Approval information/letter/labeling

Memorandum/Reviews

• Chairman's Summary
• Statistical Review and Evaluation
• Pharmacology / Toxicology Review Memorandum
• ZymoGenetics Recombinant Thrombin, Filing
• Acknowledgement: Receipt of Request for a Waiver of Pediatric Studies
• Approval Memo
• Review of Original BLA
• Memo - Re-Evaluation of Proposed Proprietary Name
• Carton and Package Label Review
• Final Review
• Discipline Review Memo
• Pharmacology/Toxicology Review (PDF - 1.1 MB)
• Bioresearch Monitoring Inspection Results
• Classification as Major Amendment
• 6/15/2007 Mid-Cycle Review - Chemistry, Manufacturing,Controls
• 6/2/2007 Mid-Cycle Review - Chemistry, Manufacturing, and Controls
• Review of Proposed Proprietary Name
• Bioresearch Monitoring "Mid-Cycle" Review Report
• Mid-Cycle Review

Administrative Documents

• Officer/Employee List
• Categorical exclusion under 21 CFR 25.31(c)
• DMPQ questions for STN 125248
• 2/2/2007 Filing Meeting Email
• 1/31/2007 Filing Meeting Email 1
• 1/31/2007 Filing Meeting Email 2

Correspondence

• 1/9/2008 Pediatric Deferral Email
• Amendment Acknowledgment Letter
• Proprietary Name Letter
• 7/31/2007 Fax
• 7/3/2007 Telecon
• 6/22/2007 Fax
• 2/16/2007 Telecon Information Request
• 2/15/2007 Telecon Information Request
• Filing Notification Letter
• Acknowledgment Letter (PDF - 56 KB)