Product Details for: Profilnine, Profilnine Hp, Profilnine Ht, Profilnine Sd

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intravenous
1000IU
Single-Dose Vial
351(a)
Profilnine, Profilnine Hp, Profilnine Ht, Profilnine Sd
Rx
002
For Injection
Intravenous
1500IU
Single-Dose Vial
351(a)
Profilnine, Profilnine Hp, Profilnine Ht, Profilnine Sd
Rx
003
For Injection
Intravenous
500IU
Single-Dose Vial
351(a)
Profilnine, Profilnine Hp, Profilnine Ht, Profilnine Sd
Rx
Proper Name
Factor IX Complex
BLA Number
102476
Applicant
Grifols Biologicals LLC
Original Approval Date
July 20, 1981
Date of First Licensure
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