Product Details for: Nuwiq

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intravenous
500IU
Vial
351(a)
Nuwiq
Rx
002
For Injection
Intravenous
1000IU
Vial
351(a)
Nuwiq
Rx
003
For Injection
Intravenous
250IU
Single-Dose Vial
351(a)
Nuwiq
Rx
004
For Injection
Intravenous
2000IU
Single-Dose Vial
351(a)
Nuwiq
Rx
005
For Injection
Intravenous
2500IU
Single-Dose Vial
351(a)
Nuwiq
Rx
006
For Injection
Intravenous
4000IU
Single-Dose Vial
351(a)
Nuwiq
Rx
007
For Injection
Intravenous
3000IU
Single-Dose Vial
351(a)
Nuwiq
Rx
008
For Injection
Intravenous
1500IU
Single-Dose Vial
351(a)
Nuwiq
Rx
Proper Name
Antihemophilic Factor (Recombinant)
BLA Number
125555
Applicant
Octapharma Pharmazeutika Produktionsges.m.b.H.
Original Approval Date
September 4, 2015
Date of First Licensure
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