FDA.reportPublic FDA data

Application 091170

Type
ANDA
Sponsor
BRECKENRIDGE

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
42023-151Zoledronic AcidZoledronic AcidPar Pharmaceutical Companies, Inc.ANDACurrent
51991-065Zoledronic AcidZoledronic AcidBreckenridge Pharmaceutical, IncANDACurrent
51991-065Zoledronic AcidZoledronic AcidBreckenridge Pharmaceutical, IncANDACurrent
51991-065Zoledronic AcidZoledronic AcidBreckenridge Pharmaceutical, IncANDACurrent
51991-065Zoledronic AcidZoledronic AcidBreckenridge Pharmaceutical, IncANDACurrent
68001-366Zoledronic AcidZoledronic AcidBluePoint LaboratoriesANDACurrent
68001-366Zoledronic AcidZoledronic AcidBluePoint LaboratoriesANDACurrent
68001-366Zoledronic AcidZoledronic AcidBluePoint LaboratoriesANDACurrent