FDA.reportPublic FDA data

Application 078963

Type
ANDA
Sponsor
ORCHID HLTHCARE

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
42043-160ModafinilModafinilOrchidPharma IncANDACurrent
42043-160ModafinilModafinilOrchidPharma IncANDACurrent
42043-160ModafinilModafinilOrchidPharma IncANDACurrent
42043-160ModafinilModafinilOrchidPharma IncANDACurrent
42043-161ModafinilModafinilOrchidPharma IncANDACurrent
42043-161ModafinilModafinilOrchidPharma IncANDACurrent
42043-161ModafinilModafinilOrchidPharma IncANDACurrent
42043-161ModafinilModafinilOrchidPharma IncANDACurrent
50742-152ModafinilModafinilIngenus Pharmaceuticals, LLCANDACurrent
50742-153ModafinilModafinilIngenus Pharmaceuticals, LLCANDACurrent
55700-688ModafinilModafinilLake Erie Medical DBA Quality Care Products LLCANDACurrent
68071-2844ModafinilModafinilNuCare Pharmaceuticals,Inc.ANDACurrent
68788-8079ModafinilModafinilPreferred Pharmaceuticals Inc.ANDACurrent
68788-8079ModafinilModafinilPreferred Pharmaceuticals Inc.ANDACurrent
68788-8280ModafinilModafinilPreferred Pharmaceuticals Inc.ANDACurrent
69452-342ModafinilModafinilBionpharma Inc.ANDACurrent
69452-343ModafinilModafinilBionpharma Inc.ANDACurrent
71335-1402ModafinilModafinilBryant Ranch PrepackANDACurrent
71335-1402ModafinilModafinilBryant Ranch PrepackANDACurrent
71335-1793ModafinilModafinilBryant Ranch PrepackANDACurrent
71335-1793ModafinilModafinilBryant Ranch PrepackANDACurrent