Product Details for: YIMMUGO
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intravenous
5G/50ML
Single-Dose Vial
351(a)
YIMMUGO
Rx
002
For Injection
Intravenous
10G/100ML
Single-Dose Vial
351(a)
YIMMUGO
Rx
003
For Injection
Intravenous
20G/200ML
Single-Dose Vial
351(a)
YIMMUGO
Rx
Proper Name
immune globulin intravenous, human-dira
immune globulin intravenous, human-dira
BLA Number
125810
125810
Applicant
Biotest AG
Biotest AG
Original Approval Date
June 13, 2024
June 13, 2024
Date of First Licensure