FDA.reportPublic FDA data

Application 090964

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYMORPHONE HYDROCHLORIDEOXYMORPHONE HYDROCHLORIDETABLET;ORAL5MGNoNo
002OXYMORPHONE HYDROCHLORIDEOXYMORPHONE HYDROCHLORIDETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0283Oxymorphone Hydrochlorideoxymorphone hydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0283Oxymorphone Hydrochlorideoxymorphone hydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0283Oxymorphone Hydrochlorideoxymorphone hydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0283Oxymorphone Hydrochlorideoxymorphone hydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0283Oxymorphone Hydrochlorideoxymorphone hydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0284Oxymorphone Hydrochlorideoxymorphone hydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0284Oxymorphone Hydrochlorideoxymorphone hydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0284Oxymorphone Hydrochlorideoxymorphone hydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0284Oxymorphone Hydrochlorideoxymorphone hydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0284Oxymorphone Hydrochlorideoxymorphone hydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent