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STN: BL 125248
Proper Name: Thrombin, topical (Recombinant)
Manufacturer: ZymoGenetics, Inc, License #1758
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 (such as suture, ligature, or cautery) is ineffective or impractical in adults and pediatric populations greater than or equal to one month of age. (1)
March 15, 2013 Approval Letter - RECOTHROM
STN: BL 125248/370, pediatric indication for use of RECOTHROM in children ages 1 month to 16 years.
- Final Clinical Labeling Memo, February 21, 2013 - RECOTHROM (PDF - 52KB)
Clinical Review Memo, Pediatric Study, May 4, 2011 - RECOTHROM(PDF - 206KB) January 17, 2008 Approval Letter - RECOTHROM Approval History, Letters, Reviews and Related Documents - RECOTHROM
FDA Online Label Repository
Search this database for drug labeling and other information. The content has not been altered or verified by the FDA and may not be the labeling on currently distributed products or identical to the labeling that is approved.
- Press Release: FDA Approves First Clotting Solution Made Using Recombinant DNA Technology