FDA.reportPublic FDA data

Application 040090

Type
ANDA
Sponsor
ANDA REPOSITORY

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ISONIAZIDISONIAZIDTABLET;ORAL100MGNoNo
002ISONIAZIDISONIAZIDTABLET;ORAL300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
46672-865isoniazidisoniazidMikart, LLCANDACurrent
46672-865isoniazidisoniazidMikart, Inc.ANDACurrent
46672-866isoniazidisoniazidMikart, LLCANDACurrent
46672-866isoniazidisoniazidMikart, Inc.ANDACurrent