NDC 0944-3053

ADVATE

Antihemophilic Factor (recombinant)

ADVATE is a Kit in the Plasma Derivative category. It is labeled and distributed by Baxalta Us Inc.. The primary component is .

Product ID0944-3053_2da612a3-e4f0-4190-9467-be7df2c98028
NDC0944-3053
Product TypePlasma Derivative
Proprietary NameADVATE
Generic NameAntihemophilic Factor (recombinant)
Dosage FormKit
Marketing Start Date2011-12-15
Marketing CategoryBLA / BLA
Application NumberBLA125063
Labeler NameBaxalta US Inc.
Active Ingredient Strength0
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0944-3053-02

1 BLISTER PACK in 1 CARTON (0944-3053-02) > 1 CONTAINER in 1 BLISTER PACK (0944-3053-04) > 1 KIT in 1 CONTAINER (0944-3053-03) * 5 mL in 1 VIAL, GLASS (0944-2943-02) * 2 mL in 1 VIAL, GLASS
Marketing Start Date2011-12-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0944-3053-03 [00944305303]

Advate KIT
Marketing CategoryBLA
Application NumberBLA125063
Product TypePLASMA DERIVATIVE
Marketing Start Date2011-12-15

NDC 0944-3053-04 [00944305304]

Advate KIT
Marketing CategoryBLA
Application NumberBLA125063
Product TypePLASMA DERIVATIVE
Marketing Start Date2011-12-15

NDC 0944-3053-02 [00944305302]

Advate KIT
Marketing CategoryBLA
Application NumberBLA125063
Product TypePLASMA DERIVATIVE
Billing UnitEA
Marketing Start Date2011-12-15

Drug Details

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

NDCBrand NameGeneric Name
0944-3045ADVATEADVATE
0944-3052ADVATEADVATE
0944-3053ADVATEADVATE
0944-3051ADVATEADVATE
0944-3054ADVATEADVATE
0944-3047ADVATEADVATE
0944-3046ADVATEADVATE
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 [ADVATE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ADVATE
ADVATE
78075589 2867685 Live/Registered
BAXALTA INCORPORATED
2001-07-25

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