Product Approval Information
Proper Name: Thrombin, topical (Recombinant)
Tradename: RECOTHROM
Manufacturer: ZymoGenetics, Inc, License #1758
Package Insert (PDF - 214 KB) - Approved: January 17, 2008
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Danger Giving Topical Thrombin Intravascularly - 8/2008
Date: January 17, 2008
Indication: An aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is ineffective or impractical
January 17, 2008 Approval Letter
FDA Approves First Clotting Solution Made Using Recombinant DNA Technology - January 17, 2008
Approval History, Letters, Reviews, and Related Documents