FDA.reportPublic FDA data

Application 209578

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
68083-256Zoledronic acidZoledronic acidGland Pharma LimitedANDACurrent
68083-256Zoledronic acidZoledronic acidGland Pharma LimitedANDACurrent
70860-802Zoledronic Acidzoledronic acidAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-802Zoledronic Acidzoledronic acidAthenex Pharmaceutical Division, LLC.ANDACurrent