Product Details for: Kalbitor
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Subcutaneous
10MG/ML
Single-Dose Vial
351(a)
Kalbitor
Rx
Proper Name
ecallantide
ecallantide
BLA Number
125277
125277
Applicant
Takeda Pharmaceuticals U.S.A., Inc.
Takeda Pharmaceuticals U.S.A., Inc.
Original Approval Date
December 1, 2009
December 1, 2009
Date of First Licensure