FDA.reportPublic FDA data

Application 205279

Type
ANDA
Sponsor
ACCORD HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZOLEDRONIC ACIDZOLEDRONIC ACIDINJECTABLE;INTRAVENOUSEQ 4MG BASE/5MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-815Zoledronic Acidzoledronic AcidNorthstar RxLLCANDACurrent
16714-815Zoledronic acidzoledronic acidNorthstar RxLLCANDACurrent
16714-815Zoledronic acidzoledronic acidNorthstar RxLLCANDACurrent
16729-242Zoledronic acidzoledronic acidAccord Healthcare Inc.ANDACurrent
16729-242Zoledronic acidzoledronic acidAccord Healthcare Inc.ANDACurrent
68001-437Zoledronic acidzoledronic acidBluePoint LaboratoriesANDACurrent