Application 211501

Type
ANDA
Sponsor
SLAYBACK PHARMA LLC

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
71225-114IcatibantIcatibantSlayback Pharma LLCANDACurrent
71225-114IcatibantIcatibantSlayback Pharma LLCANDACurrent