FDA.reportPublic FDA data

Application 209125

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZOLEDRONIC ACIDZOLEDRONIC ACIDINJECTABLE;INTRAVENOUSEQ 5MG BASE/100MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
55150-283Zoledronic AcidZoledronic AcidAuroMedics Pharma LLCANDACurrent
55150-283Zoledronic AcidZoledronic AcidAuroMedics Pharma LLCANDACurrent
55150-283Zoledronic AcidZoledronic AcidAuroMedics Pharma LLCANDACurrent