FDA.reportPublic FDA data

Application 077608

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GALANTAMINE HYDROBROMIDEGALANTAMINE HYDROBROMIDETABLET;ORALEQ 4MG BASENoNo
002GALANTAMINE HYDROBROMIDEGALANTAMINE HYDROBROMIDETABLET;ORALEQ 8MG BASENoNo
003GALANTAMINE HYDROBROMIDEGALANTAMINE HYDROBROMIDETABLET;ORALEQ 12MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0090GalantamineGalantamineWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0090GalantamineGalantamineWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0090GalantamineGalantamineWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0091GalantamineGalantamineWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0091GalantamineGalantamineWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0091GalantamineGalantamineWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0092GalantamineGalantamineWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0092GalantamineGalantamineWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0092GalantamineGalantamineWest-Ward Pharmaceuticals Corp.ANDACurrent