FDA.reportPublic FDA data

Application 205780

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

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
16714-247Vancomycin HydrochlorideVancomycin HydrochlorideNorthStar Rx LLCANDACurrent
16714-247Vancomycin HydrochlorideVancomycin HydrochlorideNorthStar Rx LLCANDACurrent
16714-309Vancomycin HydrochlorideVancomycin HydrochlorideNorthStar Rx LLCANDACurrent
16714-309Vancomycin HydrochlorideVancomycin HydrochlorideNorthStar Rx LLCANDACurrent
55150-203Vancomycin HydrochlorideVancomycin HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-203Vancomycin HydrochlorideVancomycin HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-204Vancomycin HydrochlorideVancomycin HydrochlorideAuroMedics Pharma LLCANDACurrent
55150-204Vancomycin HydrochlorideVancomycin HydrochlorideAuroMedics Pharma LLCANDACurrent