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Albuminar, Albuminar-20, Albuminar-25, Albuminar-5

Albumin (Human)

351(a) Standalone BLA

Overview

Source: Purple Book
Proprietary name
Albuminar, Albuminar-20, Albuminar-25, Albuminar-5
Proper name
Albumin (Human)
Licence type
351(a)
BLA number
103955
Applicant
CSL Behring LLC
Center
CBER
Presentations
8
First licensure
—

Presentations

Source: Purple Book
Every strength and presentation recorded in the Purple Book for this product.
Strength Dosage form Route Presentation Status Licensed
10G/50ML Injection Intravenous Single-Dose Vial Disc March 17, 2000
12.5G/250ML Injection Intravenous Single-Dose Vial Disc July 17, 2000
12.5G/50ML Injection Intravenous Single-Dose Vial Disc July 17, 2000
2.5G/50ML Injection Intravenous Single-Dose Vial Disc March 17, 2000
20G/100ML Injection Intravenous Single-Dose Vial Disc March 17, 2000
25G/100ML Injection Intravenous Single-Dose Vial Disc July 17, 2000
25G/500ML Injection Intravenous Single-Dose Vial Disc July 17, 2000
5G/20ML Injection Intravenous Single-Dose Vial Disc March 17, 2000

Sources for this page

Purple Book FDA Licence type, presentations, reference product, exclusivity