Product Details for: Nabi-HB
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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intramuscular
312IU/ML
Single-Dose Vial
351(a)
Nabi-HB
Disc
002
Injection
Intramuscular
1560IU/5ML
Single-Dose Vial
351(a)
Nabi-HB
Rx
Proper Name
Hepatitis B Immune Globulin (Human)
Hepatitis B Immune Globulin (Human)
BLA Number
103945
103945
Applicant
ADMA Biologics, Inc.
ADMA Biologics, Inc.
Original Approval Date
October 23, 2001
October 23, 2001
Date of First Licensure