Application Nr Approved Date Route Status External Links
BLA125248 None None None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

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)

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Thrombin Topical Recombinant

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