Product Details for: Crofab
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intravenous
1G
Single-Dose Vial
351(a)
Crofab
Rx
Proper Name
Crotalidae Polyvalent Immune Fab (Ovine)
Crotalidae Polyvalent Immune Fab (Ovine)
BLA Number
103788
103788
Applicant
BTG International Inc.
BTG International Inc.
Original Approval Date
October 2, 2000
October 2, 2000
Date of First Licensure