Product Details for: Albutein

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
10G/50ML
Single-Dose Vial
351(a)
Albutein
Rx
002
Injection
Intravenous
20G/100ML
Single-Dose Vial
351(a)
Albutein
Rx
003
Injection
Intravenous
25G/100ML
Single-Dose Vial
351(a)
Albutein
Rx
004
Injection
Intravenous
2.5G/50ML
Single-Dose Vial
351(a)
Albutein
Rx
005
Injection
Intravenous
12.5G/50ML
Single-Dose Vial
351(a)
Albutein
Rx
006
Injection
Intravenous
5G/20ML
Single-Dose Vial
351(a)
Albutein
Rx
007
Injection
Intravenous
12.5ML/250ML
Single-Dose Vial
351(a)
Albutein
Rx
008
Injection
Intravenous
25G/500ML
Single-Dose Vial
351(a)
Albutein
Rx
009
Injection
Intravenous
5G/100ML
Bag
351(a)
Albutein
Disc
Proper Name
Albumin (Human)
BLA Number
102478
Applicant
Grifols Biologicals LLC
Original Approval Date
August 15, 1978
Date of First Licensure
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