FDA.reportPublic FDA data

Application 202930

Type
ANDA
Sponsor
GLAND PHARMA 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
60505-6110Zoledronic AcidZoledronic AcidApotex CorpANDACurrent
68083-116Zoledronic Acidzoledronic acidGland Pharma LimitedANDACurrent
68083-116Zoledronic Acidzoledronic acidGland Pharma LimitedANDACurrent