Product Details for: Alphanine, Alphanine Hp, Alphanine Sd

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
Injection
Intravenous
500IU
Single-Dose Vial
351(a)
Alphanine, Alphanine Hp, Alphanine Sd
Rx
002
Injection
Intravenous
1000IU
Single-Dose Vial
351(a)
Alphanine, Alphanine Hp, Alphanine Sd
Rx
003
Injection
Intravenous
250IU
Single-Dose Vial
351(a)
Alphanine, Alphanine Hp, Alphanine Sd
Disc
004
Injection
Intravenous
1500IU
Single-Dose Vial
351(a)
Alphanine, Alphanine Hp, Alphanine Sd
Rx
Proper Name
Coagulation Factor IX (Human)
BLA Number
103249
Applicant
Grifols Biologicals LLC
Original Approval Date
December 31, 1990
Date of First Licensure