Product Details for: Evithrom

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Solution
Topical
2ML IU/ML
Single-Dose Vial
351(a)
Evithrom
Disc
002
Solution
Topical
20ML IU/ML
Single-Dose Vial
351(a)
Evithrom
Disc
003
Solution
Topical
5ML IU/ML
Single-Dose Vial
351(a)
Evithrom
Disc
004
For Injection
Topical
1600-2400IU/ML
Single-dose vial
351(a)
Evithrom
Rx
Proper Name
Thrombin, Topical (Human)
BLA Number
125247
Applicant
Omrix Biopharmaceuticals Ltd
Original Approval Date
August 27, 2007
Date of First Licensure
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