FDA.reportPublic FDA data

Application 209966

Type
ANDA
Sponsor
CADILA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MODAFINILMODAFINILTABLET;ORAL100MGNoNo
002MODAFINILMODAFINILTABLET;ORAL200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70710-1072ModafinilModafinilZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1073ModafinilModafinilZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1051ModafinilModafinilCadila Healthcare LimitedANDACurrent
70771-1051ModafinilModafinilZydus Lifesciences LimitedANDACurrent
70771-1051ModafinilModafinilCadila Healthcare LimitedANDACurrent
70771-1051ModafinilModafinilCadila Healthcare LimitedANDACurrent
70771-1052ModafinilModafinilCadila Healthcare LimitedANDACurrent
70771-1052ModafinilModafinilCadila Healthcare LimitedANDACurrent
70771-1052ModafinilModafinilZydus Lifesciences LimitedANDACurrent
70771-1052ModafinilModafinilCadila Healthcare LimitedANDACurrent
72578-005ModafinilModafinilViona Pharmaceuticals IncANDACurrent
72578-005ModafinilModafinilViona Pharmaceuticals IncANDACurrent
72578-005ModafinilModafinilViona Pharmaceuticals IncANDACurrent
72578-005ModafinilModafinilViona Pharmaceuticals IncANDACurrent
72578-006ModafinilModafinilViona Pharmaceuticals IncANDACurrent
72578-006ModafinilModafinilViona Pharmaceuticals IncANDACurrent
72578-006ModafinilModafinilViona Pharmaceuticals IncANDACurrent
72578-006ModafinilModafinilViona Pharmaceuticals IncANDACurrent