FDA.reportPublic FDA data

Application 076715

Type
ANDA
Sponsor
WATSON LABS 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
0591-3499ModafinilModafinilActavis Pharma, Inc.ANDACurrent
0591-3499ModafinilModafinilActavis Pharma, Inc.ANDACurrent
0591-3499ModafinilModafinilActavis Pharma, Inc.ANDACurrent
0591-3500ModafinilModafinilActavis Pharma, Inc.ANDACurrent
0591-3500ModafinilModafinilActavis Pharma, Inc.ANDACurrent
0591-3500ModafinilModafinilActavis Pharma, Inc.ANDACurrent
0904-6423ModafinilModafinilMajor PharmaceuticalsANDACurrent
0904-6424ModafinilModafinilMajor PharmaceuticalsANDACurrent
42291-599ModafinilModafinilAvKARE, Inc.ANDACurrent
42291-599ModafinilModafinilAvKARE, Inc.ANDACurrent
42291-600ModafinilModafinilAvKARE, Inc.ANDACurrent
42291-600ModafinilModafinilAvKARE, Inc.ANDACurrent
42291-600ModafinilModafinilAvKAREANDACurrent
50090-3865ModafinilModafinilA-S Medication SolutionsANDACurrent
63629-7394ModafinilModafinilBryant Ranch PrepackANDACurrent
63629-7394ModafinilModafinilBryant Ranch PrepackANDACurrent