FDA.reportPublic FDA data

Application 203177

Type
ANDA
Sponsor
XELLIA PHARMS APS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BACITRACINBACITRACININJECTABLE;INJECTION50,000 UNITS/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
39822-0278BacitracinBacitracinX-GEN Pharmaceuticals, Inc.ANDACurrent
45932-0026BACITRACINBACITRACINXellia Pharmaceuticals ApSANDACurrent
70594-026BacitracinBacitracinXellia Pharmaceuticals USA LLCANDACurrent
70594-026BacitracinBacitracinXellia Pharmaceuticals USA LLCANDACurrent
70594-026BacitracinBacitracinXellia Pharmaceuticals USA LLCANDACurrent
70594-026BacitracinBacitracinXellia Pharmaceuticals USA LLCANDACurrent
72572-025BacitracinBacitracinCivica, Inc.ANDACurrent
72572-025BacitracinBacitracinCivica, Inc.ANDACurrent