FDA.reportPublic FDA data

Application 211021

Type
ANDA
Sponsor
JIANGSU HANSOH PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ICATIBANT ACETATEICATIBANT ACETATEINJECTABLE;SUBCUTANEOUSEQ 30MG BASE/3ML (EQ 10MG BASE/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
24201-207IcatibanticatibantLeucadia PharmaceuticalsANDACurrent
24201-207IcatibanticatibantLeucadia PharmaceuticalsANDACurrent
24201-207IcatibanticatibantLeucadia PharmaceuticalsANDACurrent
24201-207IcatibanticatibantLeucadia PharmaceuticalsANDACurrent
24201-207IcatibanticatibantHikma Cali Inc.ANDACurrent
24201-207IcatibanticatibantHikma Cali Inc.ANDACurrent
24201-207IcatibanticatibantHikma Cali Inc.ANDACurrent
24201-207IcatibanticatibantHikma Pharmaceuticals USA Inc.ANDACurrent