FDA.reportPublic FDA data

Application 207196

Type
ANDA
Sponsor
APPCO

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
23155-604ModafinilModafinilHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-604ModafinilModafinilHeritage Pharmaceuticals IncANDACurrent
23155-604ModafinilModafinilHeritage Pharmaceuticals IncANDACurrent
23155-604ModafinilModafinilHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-605ModafinilModafinilHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-605ModafinilModafinilHeritage Pharmaceuticals IncANDACurrent
23155-605ModafinilModafinilHeritage Pharmaceuticals IncANDACurrent
23155-605ModafinilModafinilHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent