FDA.reportPublic FDA data

Application 204125

Type
ANDA
Sponsor
XELLIA PHARMS APS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEINJECTABLE;INJECTIONEQ 5GM BASE/VIALNoNo
002VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEINJECTABLE;INJECTIONEQ 10GM BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63323-314Vancomycin HydrochlorideVancomycin HydrochlorideFresenius Kabi, LLCANDACurrent
68001-406Vancomycin HydrochlorideVancomycin HydrochlorideBluePoint LaboratoriesANDACurrent
68001-406Vancomycin HydrochlorideVancomycin HydrochlorideBluePoint LaboratoriesANDACurrent
68001-406Vancomycin HydrochlorideVancomycin HydrochlorideBluePoint LaboratoriesANDACurrent
68001-406Vancomycin HydrochlorideVancomycin HydrochlorideBluePoint LaboratoriesANDACurrent
68001-406Vancomycin HydrochlorideVancomycin HydrochlorideBluePoint LaboratoriesANDACurrent
68001-407Vancomycin HydrochlorideVancomycin HydrochlorideBluePoint LaboratoriesANDACurrent
68001-407Vancomycin HydrochlorideVancomycin HydrochlorideBluePoint LaboratoriesANDACurrent
68001-407Vancomycin HydrochlorideVancomycin HydrochlorideBluePoint LaboratoriesANDACurrent
68001-407Vancomycin HydrochlorideVancomycin HydrochlorideBluePoint LaboratoriesANDACurrent
68001-407Vancomycin HydrochlorideVancomycin HydrochlorideBluePoint LaboratoriesANDACurrent
70594-047Vancomycin HydrochlorideVancomycin HydrochlorideXellia Pharmaceuticals USA LLCANDACurrent
70594-047Vancomycin HydrochlorideVancomycin HydrochlorideXellia Pharmaceuticals USA LLCANDACurrent
70594-047Vancomycin HydrochlorideVancomycin HydrochlorideXellia Pharmaceuticals USA LLCANDACurrent
70594-047Vancomycin HydrochlorideVancomycin HydrochlorideXellia Pharmaceuticals USA LLCANDACurrent
70594-048Vancomycin HydrochlorideVancomycin HydrochlorideXellia Pharmaceuticals USA LLCANDACurrent
70594-048Vancomycin HydrochlorideVancomycin HydrochlorideXellia Pharmaceuticals USA LLCANDACurrent
70594-048Vancomycin HydrochlorideVancomycin HydrochlorideXellia Pharmaceuticals USANDACurrent
70594-048Vancomycin HydrochlorideVancomycin HydrochlorideXellia Pharmaceuticals USA LLCANDACurrent
70594-048Vancomycin HydrochlorideVancomycin HydrochlorideXellia Pharmaceuticals USA LLCANDACurrent
72572-803Vancomycin HydrochlorideVancomycin HydrochlorideCivica, Inc.ANDACurrent
72572-803Vancomycin HydrochlorideVancomycin HydrochlorideCivica, Inc.ANDACurrent
72572-805Vancomycin HydrochlorideVancomycin HydrochlorideCivica, Inc.ANDACurrent
72572-805Vancomycin HydrochlorideVancomycin HydrochlorideCivica, Inc.ANDACurrent