FDA.reportPublic FDA data

Application 076594

Type
ANDA
Sponsor
MYLAN PHARMS INC

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
0378-5573ModafinilmodafinilMylan Pharmaceuticals Inc.ANDACurrent
0378-5575ModafinilmodafinilMylan Pharmaceuticals Inc.ANDACurrent
43353-831ModafinilmodafinilAphena Pharma Solutions - Tennessee, LLCANDACurrent
51079-561ModafinilmodafinilMylan Institutional Inc.ANDACurrent
51079-561ModafinilmodafinilMylan Institutional Inc.ANDACurrent
51079-562ModafinilmodafinilMylan Institutional Inc.ANDACurrent
51079-562ModafinilmodafinilMylan Institutional Inc.ANDACurrent
68788-7408ModafinilmodafinilPreferred Pharmaceuticals Inc.ANDACurrent
68788-7408ModafinilmodafinilPreferred Pharmaceuticals Inc.ANDACurrent
71335-0997ModafinilmodafinilBryant Ranch PrepackANDACurrent
71335-0997ModafinilmodafinilBryant Ranch PrepackANDACurrent