NDC 0026-3783

Kogenate FS

Antihemophilic Factor (recombinant)

Kogenate FS is a Kit in the Plasma Derivative category. It is labeled and distributed by Bayer Healthcare Llc. The primary component is .

Product ID0026-3783_0b17ed3f-5688-45e3-883e-4ebf85e89f26
NDC0026-3783
Product TypePlasma Derivative
Proprietary NameKogenate FS
Generic NameAntihemophilic Factor (recombinant)
Dosage FormKit
Marketing Start Date2013-06-26
Marketing CategoryBLA / BLA
Application NumberBLA103332
Labeler NameBayer HealthCare LLC
Active Ingredient Strength0
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0026-3783-35

1 KIT in 1 BOX (0026-3783-35) * 2.5 mL in 1 VIAL, SINGLE-USE (0026-4783-01) * 2.5 mL in 1 SYRINGE (0026-0426-02)
Marketing Start Date2013-06-26
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0026-3783-30 [00026378330]

Kogenate FS KIT
Marketing CategoryBLA
Application NumberBLA103332
Product TypePLASMA DERIVATIVE
Billing UnitEA
Marketing Start Date2000-06-26
Marketing End Date2014-01-31

NDC 0026-3783-35 [00026378335]

Kogenate FS KIT
Marketing CategoryBLA
Application NumberBLA103332
Product TypePLASMA DERIVATIVE
Billing UnitEA
Marketing Start Date2013-06-26

Drug Details

NDC Crossover Matching brand name "Kogenate FS" or generic name "Antihemophilic Factor (recombinant)"

NDCBrand NameGeneric Name
0026-3782Kogenate FSAntihemophilic Factor (Recombinant)
0026-3783Kogenate FSAntihemophilic Factor (Recombinant)
0026-3785Kogenate FSAntihemophilic Factor (Recombinant)
0026-3786Kogenate FSAntihemophilic Factor (Recombinant)
0026-3787Kogenate FSAntihemophilic Factor (Recombinant)
0026-3821KovaltryAntihemophilic Factor (Recombinant)
0026-3822KovaltryAntihemophilic Factor (Recombinant)
0026-3824KovaltryAntihemophilic Factor (Recombinant)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.