FDA.reportPublic FDA data

Application 076904

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RISPERIDONERISPERIDONESOLUTION;ORAL1MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0063RisperidoneRisperidoneHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0063RisperidoneRisperidoneWest-Ward Pharmaceuticals CorpANDACurrent
0054-0063RisperidoneRisperidoneHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0063RisperidoneRisperidoneHikma Pharmaceuticals USA Inc.ANDACurrent
0054-0063RisperidoneRisperidoneWest-Ward Pharmaceuticals CorpANDACurrent
17856-0063RisperidoneRisperidoneATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-0063RisperidoneRisperidoneATLANTIC BIOLOGICALS CORP.ANDACurrent
17856-0063RisperidoneRisperidoneATLANTIC BIOLOGICALS CORP.ANDACurrent