FDA.reportPublic FDA data

Application 211713

Type
ANDA
Sponsor
XELLIA PHARMS APS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MICAFUNGIN SODIUMMICAFUNGIN SODIUMINJECTABLE;INTRAVENOUSEQ 50MG BASE/VIALNoNo
002MICAFUNGIN SODIUMMICAFUNGIN SODIUMINJECTABLE;INTRAVENOUSEQ 100MG BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70594-036MicafunginMicafungin SodiumXellia Pharmaceuticals USA LLCANDACurrent
70594-036MicafunginMicafungin SodiumXellia Pharmaceuticals USA LLCANDACurrent
70594-036MicafunginMicafungin SodiumXellia Pharmaceuticals USA LLCANDACurrent
70594-036MicafunginMicafungin SodiumXellia Pharmaceuticals USA LLCANDACurrent
70594-037MicafunginMicafungin SodiumXellia Pharmaceuticals USA LLCANDACurrent
70594-037MicafunginMicafungin SodiumXellia Pharmaceuticals USA LLCANDACurrent
72572-427MicafunginMicafungin sodiumCivica, Inc.ANDACurrent
72572-427Micafungin sodiumMicafungin sodiumCivica, Inc.ANDACurrent
72572-427Micafungin sodiumMicafungin sodiumCivica, Inc.ANDACurrent