thrombin topical recombinant

FDA Drug Profile — RECOTHROM

Drug Details

Generic Name
thrombin topical recombinant
Brand Names
RECOTHROM
Application Number
BLA125248
Sponsor
Baxter Healthcare Corporation
NDC Codes
3
Dosage Forms
KIT
Routes
N/A
Active Ingredients
N/A

Indications and Usage

1 INDICATIONS AND USAGE RECOTHROM Thrombin topical (Recombinant), is a topical thrombin indicated to aid 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. RECOTHROM may be used in conjunction with an absorbable gelatin sponge, USP. RECOTHROM Thrombin topical (Recombinant), is a topical thrombin indicated to aid 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) RECOTHROM may be used in conjunction with an absorbable gelatin sponge, USP. (1)