FDA.reportPublic FDA data

Application 090250

Type
ANDA
Sponsor
SANDOZ

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
0781-3187Vancomycin HydrochlorideVancomycin HydrochlorideSandoz IncANDACurrent
0781-3187Vancomycin HydrochlorideVancomycin HydrochlorideSandoz IncANDACurrent
0781-3188Vancomycin HydrochlorideVancomycin HydrochlorideSandoz IncANDACurrent
0781-3188Vancomycin HydrochlorideVancomycin HydrochlorideSandoz IncANDACurrent