FDA.reportPublic FDA data

Application 090543

Type
ANDA
Sponsor
HIKMA PHARMS

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
0143-9968ModafinilmodafinilWest-Ward Pharmaceuticals CorpANDACurrent
0143-9968ModafinilmodafinilHikma Pharmaceuticals USA Inc.ANDACurrent
0143-9969ModafinilmodafinilWest-Ward Pharmaceuticals CorpANDACurrent
0143-9969ModafinilmodafinilHikma Pharmaceuticals USA Inc.ANDACurrent
59115-069ModafinilmodafinilHikma PharmaceuticalANDACurrent
59115-069ModafinilmodafinilHikma PharmaceuticalANDACurrent
59115-070ModafinilmodafinilHikma PharmaceuticalANDACurrent
59115-070ModafinilmodafinilHikma PharmaceuticalANDACurrent
71335-0811ModafinilmodafinilBryant Ranch PrepackANDACurrent
71335-0811ModafinilmodafinilBryant Ranch PrepackANDACurrent