FDA.reportPublic FDA data

Application 205779

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

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
55150-205Vancomycin HydrochlorideVancomycin HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-205Vancomycin HydrochlorideVancomycin HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-205Vancomycin HydrochlorideVancomycin HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-206Vancomycin HydrochlorideVancomycin HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-206Vancomycin HydrochlorideVancomycin HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-206Vancomycin HydrochlorideVancomycin HydrochlorideAuroMedics Pharma LLCANDACurrent