Product Details for: Bayhep B, Hyperhep B S/D

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intramuscular
220U/ML
Pre-Filled Syringe
351(a)
Bayhep B, Hyperhep B S/D
Rx
002
Injection
Intramuscular
220U/ML
Single-Dose Vial
351(a)
Bayhep B, Hyperhep B S/D
Rx
003
Injection
Intramuscular
220U/.5ML
Pre-Filled Syringe
351(a)
Bayhep B, Hyperhep B S/D
Rx
004
Injection
Intramuscular
220U/.5ML
Single-Dose Vial
351(a)
Bayhep B, Hyperhep B S/D
Rx
005
Injection
Intramuscular
220IU/5ML
Single-Dose Vial
351(a)
Bayhep B, Hyperhep B S/D
Rx
Proper Name
Hepatitis B Immune Globulin (Human)
BLA Number
101146
Applicant
Grifols Therapeutics LLC
Original Approval Date
September 23, 1977
Date of First Licensure
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