FDA.reportPublic FDA data

Application 202182

Type
ANDA
Sponsor
HIKMA FARMACEUTICA

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
0143-9642Zoledronic Acidzoledronic acidHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9642Zoledronic Acidzoledronic acidWest-Ward Pharmaceuticals CorpANDACurrent