FDA.reportPublic FDA data

Application 203723

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ESTRADIOL VALERATEESTRADIOL VALERATEINJECTABLE;INJECTION10MG/MLNoNo
002ESTRADIOL VALERATEESTRADIOL VALERATEINJECTABLE;INJECTION20MG/MLNoNo
003ESTRADIOL VALERATEESTRADIOL VALERATEINJECTABLE;INJECTION40MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-9289Estradiol ValerateEstradiol ValerateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9289Estradiol ValerateEstradiol ValerateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9289Estradiol ValerateEstradiol ValerateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9289Estradiol ValerateEstradiol ValerateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9290Estradiol ValerateEstradiol ValerateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9290Estradiol ValerateEstradiol ValerateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9290Estradiol ValerateEstradiol ValerateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9290Estradiol ValerateEstradiol ValerateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9291Estradiol ValerateEstradiol ValerateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9291Estradiol ValerateEstradiol ValerateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9291Estradiol ValerateEstradiol ValerateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9291Estradiol ValerateEstradiol ValerateHikma Pharmaceuticals USA Inc.ANDACurrent