FDA.reportPublic FDA data

Application 205749

Type
ANDA
Sponsor
GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZOLEDRONICZOLEDRONIC ACIDINJECTABLE;INTRAVENOUSEQ 4MG BASE/100MLNoNo
002ZOLEDRONIC ACIDZOLEDRONIC ACIDINJECTABLE;IV (INFUSION)EQ 4MG BASE/100MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68083-142Zoledronic Acidzoledronic AcidGland Pharma LimitedANDACurrent
68083-142Zoledronic Acidzoledronic AcidGland Pharma LimitedANDACurrent
70860-210Zoledronic Acidzoledronic acidAthenex Pharmaceutical Division, LLC.ANDACurrent
70860-210Zoledronic Acidzoledronic acidAthenex Pharmaceutical Division, LLC.ANDACurrent