FDA.reportPublic FDA data

Application 204107

Type
ANDA
Sponsor
XELLIA PHARMS APS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEINJECTABLE;INJECTIONEQ 500MG BASE/VIALNoNo
002VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEINJECTABLE;INJECTIONEQ 1GM BASE/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63323-221Vancomycin HydrochlorideVancomycin HydrochlorideFresenius Kabi, LLCANDACurrent
63323-221Vancomycin HydrochlorideVancomycin HydrochlorideFresenius Kabi, LLCANDACurrent
63323-221Vancomycin HydrochlorideVancomycin HydrochlorideFresenius Kabi, LLCANDACurrent
63323-221Vancomycin HydrochlorideVancomycin HydrochlorideFresenius Kabi, LLCANDACurrent
63323-221Vancomycin HydrochlorideVancomycin HydrochlorideFresenius Kabi, LLCANDACurrent
63323-221Vancomycin HydrochlorideVancomycin HydrochlorideFresenius Kabi, LLCANDACurrent
63323-221Vancomycin HydrochlorideVancomycin HydrochlorideFresenius Kabi, LLCANDACurrent
63323-284Vancomycin HydrochlorideVancomycin HydrochlorideFresenius Kabi, LLCANDACurrent
63323-284Vancomycin HydrochlorideVancomycin HydrochlorideFresenius Kabi, LLCANDACurrent
63323-284Vancomycin HydrochlorideVancomycin HydrochlorideFresenius Kabi, LLCANDACurrent
68001-465Vancomycin Hydrochloridevancomycin hydrochlorideBluePoint LaboratoriesANDACurrent
68001-465Vancomycin Hydrochloridevancomycin hydrochlorideBluePoint LaboratoriesANDACurrent
68001-465Vancomycin Hydrochloridevancomycin hydrochlorideBluePoint LaboratoriesANDACurrent
68001-466Vancomycin Hydrochloridevancomycin hydrochlorideBluePoint LaboratoriesANDACurrent
68001-466Vancomycin Hydrochloridevancomycin hydrochlorideBluePoint LaboratoriesANDACurrent
68001-466Vancomycin Hydrochloridevancomycin hydrochlorideBluePoint LaboratoriesANDACurrent
70594-045Vancomycin Hydrochloridevancomycin hydrochlorideXellia Pharmaceuticals USA LLCANDACurrent
70594-045Vancomycin Hydrochloridevancomycin hydrochlorideXellia Pharmaceuticals USA LLCANDACurrent
70594-045Vancomycin Hydrochloridevancomycin hydrochlorideXellia Pharmaceuticals USA LLCANDACurrent
70594-045Vancomycin Hydrochloridevancomycin hydrochlorideXellia Pharmaceuticals USA LLCANDACurrent
70594-045Vancomycin Hydrochloridevancomycin hydrochlorideXellia Pharmaceuticals USA LLCANDACurrent
70594-046Vancomycin Hydrochloridevancomycin hydrochlorideXellia Pharmaceuticals USA LLCANDACurrent
70594-046Vancomycin Hydrochloridevancomycin hydrochlorideXellia Pharmaceuticals USA LLCANDACurrent
70594-046Vancomycin Hydrochloridevancomycin hydrochlorideXellia Pharmaceuticals USA LLCANDACurrent
70594-046Vancomycin Hydrochloridevancomycin hydrochlorideXellia Pharmaceuticals USA LLCANDACurrent
70594-046Vancomycin Hydrochloridevancomycin hydrochlorideXellia Pharmaceuticals USA LLCANDACurrent
72572-801Vancomycin HydrochlorideVancomycin HydrochlorideCivica RxANDACurrent
72572-801Vancomycin HydrochlorideVancomycin HydrochlorideCivica, Inc.ANDACurrent
72572-801Vancomycin HydrochlorideVancomycin HydrochlorideCivica, Inc.ANDACurrent
72572-801Vancomycin HydrochlorideVancomycin HydrochlorideCivica, Inc.ANDACurrent
72572-801Vancomycin HydrochlorideVancomycin HydrochlorideCivica, Inc.ANDACurrent
72572-801Vancomycin HydrochlorideVancomycin HydrochlorideCivica, Inc.ANDACurrent