Product Approval Information
Proper Name: Fibrin Sealant (Human)
Tradename: ARTISS
Manufacturer: Baxter Healthcare Corp, License #0140
STN: 125266/0
Approval Date: March 19, 2008
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Approval information/letter/labeling
Memorandum/Reviews
- Summary Basis for Regulatory Action
- Summary of Labeling Review for the Summary Basis of Regulatory Action
- Final CMC Review Memo
- Review
- Pharmacology / Toxicology Review Memorandum
- Final Review Memo (PDF - 809 KB)
- Bioresearch Monitoring Final Review Memo
- Statistical Review and Evaluation
Administrative Documents
- Officer/Employee List
- Request to waive STN 125266 from referral to Blood Products Advisory Committee
- Licensing Action Recommendation (PDF - 137 KB)
Correspondence