FDA.report

Application 077667

Type
ANDA
Sponsor
APOTEX INC

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001MODAFINILMODAFINILTABLET;ORAL100MGNoNo
002MODAFINILMODAFINILTABLET;ORAL200MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6791ModafinilmodafinilMajor PharmaceuticalsANDACurrent
0904-6791ModafinilmodafinilMajor PharmaceuticalsANDACurrent
0904-6792ModafinilmodafinilMajor PharmaceuticalsANDACurrent
0904-6792ModafinilmodafinilMajor PharmaceuticalsANDACurrent
50090-4144ModafinilmodafinilA-S Medication SolutionsANDACurrent
55700-695ModafinilmodafinilQuality Care Products, LLCANDACurrent
55700-695ModafinilmodafinilQuality Care Products, LLCANDACurrent
60429-581ModafinilmodafinilGolden State Medical Supply, Inc.ANDACurrent
60429-581ModafinilmodafinilGolden State Medical Supply, Inc.ANDACurrent
60429-582ModafinilmodafinilGolden State Medical Supply, Inc.ANDACurrent
60429-582ModafinilmodafinilGolden State Medical Supply, Inc.ANDACurrent
60505-2526ModafinilmodafinilApotex Corp.ANDACurrent
60505-2526ModafinilmodafinilApotex Corp.ANDACurrent
60505-2526ModafinilmodafinilApotex Corp.ANDACurrent
60505-2526ModafinilmodafinilApotex Corp.ANDACurrent
60505-2526ModafinilmodafinilApotex Corp.ANDACurrent
60505-2527ModafinilmodafinilApotex Corp.ANDACurrent
60505-2527ModafinilmodafinilApotex Corp.ANDACurrent
60505-2527ModafinilmodafinilApotex Corp.ANDACurrent
60505-2527ModafinilmodafinilApotex Corp.ANDACurrent
60505-2527ModafinilmodafinilApotex Corp.ANDACurrent
71335-0259ModafinilmodafinilBryant Ranch PrepackANDACurrent