FDA.reportPublic FDA data

Application 204217

Type
ANDA
Sponsor
GLAND 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
63323-966Zoledronic AcidZoledronic AcidFresenius Kabi USA, LLCANDACurrent
63323-966Zoledronic AcidZoledronic AcidFresenius Kabi USA, LLCANDACurrent
68083-135Zoledronic AcidZoledronic AcidGland Pharma LimitedANDACurrent
68083-135Zoledronic AcidZoledronic AcidGland Pharma LimitedANDACurrent