NDC 58394-012

Xyntha

Antihemophilic Factor (recombinant)

Xyntha is a Kit in the Plasma Derivative category. It is labeled and distributed by Wyeth Biopharma Division Of Wyeth Pharmaceuticals Llc. The primary component is .

Product ID58394-012_091cbd40-dc2b-4630-b537-11a3eaca2c44
NDC58394-012
Product TypePlasma Derivative
Proprietary NameXyntha
Generic NameAntihemophilic Factor (recombinant)
Dosage FormKit
Marketing Start Date2008-08-01
Marketing CategoryBLA / BLA
Application NumberBLA125264
Labeler NameWyeth BioPharma Division of Wyeth Pharmaceuticals LLC
Active Ingredient Strength0
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 58394-012-01

1 KIT in 1 CARTON (58394-012-01) * 4 mL in 1 SYRINGE (58394-018-01) * 1 mL in 1 PACKET * 4 mL in 1 VIAL, SINGLE-USE (58394-112-01)
Marketing Start Date2008-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58394-012-01 [58394001201]

Xyntha KIT
Marketing CategoryBLA
Application NumberBLA125264
Product TypePLASMA DERIVATIVE
Billing UnitEA
Marketing Start Date2008-08-01

Drug Details

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

NDCBrand NameGeneric Name
58394-014XynthaXyntha
58394-015XynthaXyntha
58394-022XynthaXyntha
58394-024XynthaXyntha
58394-013XynthaXyntha
58394-012XynthaXyntha
58394-016XynthaXyntha
58394-023XynthaXyntha
58394-025XynthaXyntha
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)

Trademark Results [Xyntha]

Mark Image

Registration | Serial
Company
Trademark
Application Date
XYNTHA
XYNTHA
78754885 3535448 Live/Registered
WYETH LLC
2005-11-16
XYNTHA
XYNTHA
77380592 3607161 Live/Registered
WYETH LLC
2008-01-25

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