Product Details for: Hepagam B

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intramuscular
>1560IU/5ML
Single-Dose Vial
351(a)
Hepagam B
Rx
002
Injection
Intramuscular
>312IU/ML
Single-Dose Vial
351(a)
Hepagam B
Rx
Proper Name
Hepatitis B Immune Globulin (Human)
BLA Number
125035
Applicant
Kamada Ltd.
Original Approval Date
January 27, 2006
Date of First Licensure