FDA.reportPublic FDA data

Application 205722

Type
ANDA
Sponsor
XELLIA PHARMS APS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TIGECYCLINETIGECYCLINEPOWDER;INTRAVENOUS50MG/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70594-035TigecyclineTigecyclineXellia Pharmaceuticals USA LLCANDACurrent
70594-035TigecyclineTigecyclineXellia Pharmaceuticals USA LLCANDACurrent