FDA.reportPublic FDA data

Application 090520

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALENDRONATE SODIUMALENDRONATE SODIUMSOLUTION;ORALEQ 70MG BASE/75MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0282Alendronate SodiumAlendronate SodiumHikma Pharmaceuticals USA Inc.ANDACurrent
51224-301Alendronate SodiumAlendronate SodiumTAGI Pharma, Inc.ANDACurrent
51224-301Alendronate SodiumAlendronate SodiumTAGI Pharma, Inc.ANDACurrent
51224-301Alendronate SodiumAlendronate SodiumTAGI Pharma, Inc.ANDACurrent
51224-301Alendronate SodiumAlendronate SodiumTAGI Pharma, Inc.ANDACurrent