FDA.reportPublic FDA data

Application 212446

Type
ANDA
Sponsor
CIPLA

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
69097-664ICATIBANTICATIBANTCipla USA Inc.ANDACurrent
69097-664ICATIBANTICATIBANTCipla USA Inc.ANDACurrent
69097-664ICATIBANTICATIBANTCipla USA Inc.ANDACurrent
70709-013SAJAZIRICATIBANTCycle Pharmaceuticals Ltd-UkANDACurrent
70709-013ICATIBANTICATIBANTCycle Pharmaceuticals Ltd-UkANDACurrent
70709-013SAJAZIRICATIBANTCycle Pharmaceuticals Ltd-UkANDACurrent