NDC 60492-0075

BAT

Botulism Antitoxin Heptavalent

BAT is a Intravenous Liquid in the Plasma Derivative category. It is labeled and distributed by Emergent Biosolutions Canada Inc.. The primary component is Equine Botulinum Neurotoxin A Immune Fab2; Equine Botulinum Neurotoxin B Immune Fab2; Equine Botulinum Neurotoxin C Immune Fab2; Equine Botulinum Neurotoxin D Immune Fab2; Equine Botulinum Neurotoxin E Immune Fab2; Equine Botulinum Neurotoxin F Immune Fab2; Equine Botulinum Neurotoxin G Immune Fab2.

Product ID60492-0075_35d3ee15-d4d5-4fba-9c03-b5a625c5048d
NDC60492-0075
Product TypePlasma Derivative
Proprietary NameBAT
Generic NameBotulism Antitoxin Heptavalent
Dosage FormLiquid
Route of AdministrationINTRAVENOUS
Marketing Start Date2013-03-01
Marketing CategoryBLA / BLA
Application NumberBLA125462
Labeler NameEmergent BIoSolutions Canada Inc.
Substance NameEQUINE BOTULINUM NEUROTOXIN A IMMUNE FAB2; EQUINE BOTULINUM NEUROTOXIN B IMMUNE FAB2; EQUINE BOTULINUM NEUROTOXIN C IMMUNE FAB2; EQUINE BOTULINUM NEUROTOXIN D IMMUNE FAB2; EQUINE BOTULINUM NEUROTOXIN E IMMUNE FAB2; EQUINE BOTULINUM NEUROTOXIN F IMMUNE FAB2; EQUINE BOTULINUM NEUROTOXIN G IMMUNE FAB2
Active Ingredient Strength4500 [iU]/10mL; [iU]/10mL; [iU]/10mL; [iU]/10mL; [iU]/10mL; [iU]/10mL; [iU]/10mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 60492-0075-2

50 mL in 1 VIAL, GLASS (60492-0075-2)
Marketing Start Date2013-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 60492-0075-3 [60492007503]

BAT LIQUID
Marketing CategoryBLA
Application NumberBLA125462
Product TypePLASMA DERIVATIVE
Marketing Start Date2013-03-01

NDC 60492-0075-2 [60492007502]

BAT LIQUID
Marketing CategoryBLA
Application NumberBLA125462
Product TypePLASMA DERIVATIVE
Marketing Start Date2013-03-01

NDC 60492-0075-4 [60492007504]

BAT LIQUID
Marketing CategoryBLA
Application NumberBLA125462
Product TypePLASMA DERIVATIVE
Marketing Start Date2020-01-13

Drug Details

Active Ingredients

IngredientStrength
EQUINE BOTULINUM NEUROTOXIN A IMMUNE FAB24500 [iU]/10mL

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