Product Details for: prolastin,prolastin-c,prolastin-c liquid

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intravenous
1000MG
Single-Dose Vial
351(a)
prolastin,prolastin-c,prolastin-c liquid
Rx
002
For Injection
Intravenous
500MG
Single-Dose Vial
351(a)
prolastin,prolastin-c,prolastin-c liquid
Disc
003
Injection
Intravenous
1000MG/20ML
Single-Dose Vial
351(a)
prolastin,prolastin-c,prolastin-c liquid
Rx
004
Injection
Intravenous
4000MG/80ML
Single-Dose Vial
351(a)
prolastin,prolastin-c,prolastin-c liquid
Rx
005
Injection
Intravenous
500MG/10ML
Single-Dose Vial
351(a)
prolastin,prolastin-c,prolastin-c liquid
Rx
Proper Name
Alpha-1-Proteinase Inhibitor (Human)
BLA Number
103174
Applicant
Grifols Therapeutics LLC
Original Approval Date
December 2, 1987
Date of First Licensure
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