Product Details for: Helixate Fs, Kogenate, Kogenate Fs

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Product Number
Dosage Form
Route of Administration
Strength
Product Presentation
License Type
Proprietary Name
Marketing Status
001
For Injection
Intravenous
250IU
Single-Dose Vial
351(a)
Helixate Fs, Kogenate, Kogenate Fs
Disc
002
For Injection
Intravenous
500IU
Single-Dose Vial
351(a)
Helixate Fs, Kogenate, Kogenate Fs
Disc
003
For Injection
Intravenous
1000IU
Single-Dose Vial
351(a)
Helixate Fs, Kogenate, Kogenate Fs
Disc
004
For Injection
Intravenous
2000IU
Single-Dose Vial
351(a)
Helixate Fs, Kogenate, Kogenate Fs
Disc
005
For Injection
Intravenous
3000IU
Single-Dose Vial
351(a)
Helixate Fs, Kogenate, Kogenate Fs
Disc
Proper Name
Antihemophilic Factor (Recombinant)
BLA Number
103332
Applicant
Bayer HealthCare LLC
Original Approval Date
August 20, 2002
Date of First Licensure
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