Product Details for: Buminate, Flexbumin
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
20G/100ML
Bottle
351(a)
Buminate, Flexbumin
Rx
002
Injection
Intravenous
25G/100ML
Bottle
351(a)
Buminate, Flexbumin
Rx
003
Injection
Intravenous
12.5G/50ML
Bottle
351(a)
Buminate, Flexbumin
Rx
004
Injection
Intravenous
10G/50ML
Bottle
351(a)
Buminate, Flexbumin
Rx
005
Injection
Intravenous
12.5G/250ML
Bottle
351(a)
Buminate, Flexbumin
Rx
Proper Name
Albumin (Human)
Albumin (Human)
BLA Number
101452
101452
Applicant
Takeda Pharmaceuticals U.S.A., Inc.
Takeda Pharmaceuticals U.S.A., Inc.
Original Approval Date
March 3, 1954
March 3, 1954
Date of First Licensure