FDA.reportPublic FDA data

Application 091384

Type
ANDA
Sponsor
AMNEAL PHARMS

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
17856-0380RisperidoneRisperidoneAtlantic Biologicals CorpsANDACurrent
17856-0673RisperidoneRisperidoneAtlantic Biologicals CorpsANDACurrent
17856-0674RisperidoneRisperidoneATLANTIC BIOLOGICALS CORP.ANDACurrent
65162-673RisperidoneRisperidoneAmneal Pharmaceuticals LLCANDACurrent
65162-673RisperidoneRisperidoneAmneal Pharmaceuticals LLCANDACurrent
65162-673RisperidoneRisperidoneAmneal Pharmaceuticals LLCANDACurrent
65162-673RisperidoneRisperidoneAmneal Pharmaceuticals LLCANDACurrent
70518-3463RisperidoneRisperidoneREMEDYREPACK INC.ANDACurrent