Product Approval Information
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
- 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