FDA.reportPublic FDA data

Application 078185

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GALANTAMINE HYDROBROMIDEGALANTAMINE HYDROBROMIDESOLUTION;ORAL4MG/MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0137Galantamine HydrobromideGalantamine HydrobromideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0137Galantamine HydrobromideGalantamine HydrobromideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0137Galantamine HydrobromideGalantamine HydrobromideHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0137Galantamine HydrobromideGalantamine HydrobromideWest-Ward Pharmaceuticals Corp.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
18477ORIG2009-02-24
31343ORIG2009-02-03