Product Details for: Recothrom
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Solution
Topical
5000IU
Single-Dose Vial
351(a)
Recothrom
Rx
002
For Solution
Topical
20000IU
Single-Dose Vial
351(a)
Recothrom
Rx
Proper Name
Thrombin topical (Recombinant)
Thrombin topical (Recombinant)
BLA Number
125248
125248
Applicant
Baxter Healthcare Corporation
Baxter Healthcare Corporation
Original Approval Date
January 17, 2008
January 17, 2008
Date of First Licensure