FDA.reportPublic FDA data

Application 206005

Type
ANDA
Sponsor
XELLIA PHARMS APS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DAPTOMYCINDAPTOMYCINPOWDER;INTRAVENOUS500MG/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-2757DaptomycinDAPTOMYCINHospira Inc.ANDACurrent
0409-2757DaptomycinDaptomycinHospira Inc.ANDACurrent
0409-2757DaptomycinDaptomycinHospira Inc.ANDACurrent
63323-871DaptomycinDaptomycinFresenius Kabi USA, LLCANDACurrent
63323-871DaptomycinDaptomycinFresenius Kabi USA, LLCANDACurrent
63323-871DaptomycinDaptomycinFresenius Kabi USA, LLCANDACurrent
70594-034DaptomycinDaptomycinXellia Pharmaceuticals USA LLCANDACurrent
70594-034DaptomycinDaptomycinXellia Pharmaceuticals USA LLCANDACurrent
70594-034DaptomycinDaptomycinXellia Pharmaceuticals USA LLCANDACurrent
70594-034DaptomycinDaptomycinXellia Pharmaceuticals USA LLCANDACurrent
70594-034DaptomycinDaptomycinXellia Pharmaceuticals USA LLCANDACurrent
70594-034DaptomycinDaptomycinXellia Pharmaceuticals LLCANDACurrent
72572-102DaptomycinDaptomycinCivica, Inc.ANDACurrent
72572-102DaptomycinDaptomycinCivica, Inc.ANDACurrent
72572-102DaptomycinDaptomycinCivica, Inc.ANDACurrent