FDA.reportPublic FDA data

Application 202163

Type
ANDA
Sponsor
BRECKENRIDGE

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
42023-163Zoledronic AcidZoledronic AcidPar Pharmaceutical Companies, Inc.ANDACurrent
51991-064Zoledronic AcidZoledronic AcidBreckenridge Pharmaceutical, IncANDACurrent
51991-064Zoledronic AcidZoledronic AcidBreckenridge Pharmaceutical, IncANDACurrent