FDA.reportPublic FDA data

Application 201801

Type
ANDA
Sponsor
EMCURE PHARMS 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
23155-186Zoledronic acidZoledronic acidHeritage Pharmaceuticals Inc.ANDACurrent
23155-525Zoledronic acidZoledronic acidHeritage Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22860ORIG2013-05-02