FDA.reportPublic FDA data

Application 201783

Type
ANDA
Sponsor
EMCURE PHARMS LTD

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
23155-170Zoledronic acidZoledronic acidHeritage Pharmaceuticals Inc.ANDACurrent
23155-170Zoledronic acidZoledronic acidHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent