FDA.reportPublic FDA data

Application 203841

Type
ANDA
Sponsor
MYLAN LABS 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
67457-619Zoledronic AcidZoledronic AcidMylan Institutional LLCANDACurrent
67457-619Zoledronic AcidZoledronic AcidMylan Institutional LLCANDACurrent