FDA.reportPublic FDA data

Application 204360

Type
ANDA
Sponsor
HIKMA

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
0143-9358Vancomycin HydrochlorideVancomycin HydrochlorideWest-Ward Pharmaceuticals CorpANDACurrent
0143-9358Vancomycin HydrochlorideVancomycin HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9358Vancomycin HydrochlorideVancomycin HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9359Vancomycin HydrochlorideVancomycin HydrochlorideWest-Ward Pharmaceuticals CorpANDACurrent
0143-9359Vancomycin HydrochlorideVancomycin HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9359Vancomycin HydrochlorideVancomycin HydrochlorideHikma Pharmaceuticals USA Inc.ANDACurrent