Product Details for: BabyBig
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intravenous
100MG
Single-Dose Vial
351(a)
BabyBig
Rx
Proper Name
Botulism Immune Globulin Intravenous (Human)
Botulism Immune Globulin Intravenous (Human)
BLA Number
125034
125034
Applicant
California Department of Public Health (CDPH)
California Department of Public Health (CDPH)
Original Approval Date
October 23, 2003
October 23, 2003
Date of First Licensure