FDA.reportPublic FDA data

Application 080776

Type
ANDA
Sponsor
HIKMA INTL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002CORTISONE ACETATECORTISONE ACETATETABLET;ORAL25MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-1202Cortisone AcetateCortisone AcetateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-1202Cortisone AcetateCortisone AcetateWest-ward Pharmaceutical CorpANDACurrent
0143-1202Cortisone AcetateCortisone AcetateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9700Cortisone AcetateCortisone AcetateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9700Cortisone AcetateCortisone AcetateHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9700Cortisone AcetateCortisone AcetateWest-Ward Pharmaceuticals CorpANDACurrent
59115-161CORTISONE ACETATECORTISONE ACETATEHikma PharmaceuticalANDACurrent