FDA.reportPublic FDA data

Application 203300

Type
ANDA
Sponsor
HIKMA

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
0143-9356Vancomycin HydrochlorideVancomycin HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9356Vancomycin HydrochlorideVancomycin HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9356Vancomycin HydrochlorideVancomycin HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9356Vancomycin HydrochlorideVancomycin HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9357Vancomycin HydrochlorideVancomycin HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9357Vancomycin HydrochlorideVancomycin HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9357Vancomycin HydrochlorideVancomycin HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9357Vancomycin HydrochlorideVancomycin HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent