FDA.reportPublic FDA data

Application 200751

Type
ANDA
Sponsor
LUPIN LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ARMODAFINILARMODAFINILTABLET;ORAL50MGNoNo
002ARMODAFINILARMODAFINILTABLET; ORAL100MGNoNo
003ARMODAFINILARMODAFINILTABLET;ORAL150MGNoNo
004ARMODAFINILARMODAFINILTABLET;ORAL200MGNoNo
005ARMODAFINILARMODAFINILTABLET;ORAL250MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61919-770ArmodafinilArmodafinilDirect_RxANDACurrent
61919-770ArmodafinilArmodafinilDirect_RxANDACurrent
68180-569ArmodafinilArmodafinilLupin Pharmaceuticals, Inc.ANDACurrent
68180-569ArmodafinilArmodafinilLupin Pharmaceuticals, Inc.ANDACurrent
68180-569ArmodafinilArmodafinilLupin Pharmaceuticals, Inc.ANDACurrent
68180-571ArmodafinilArmodafinilLupin Pharmaceuticals, Inc.ANDACurrent
68180-571ArmodafinilArmodafinilLupin Pharmaceuticals, Inc.ANDACurrent
68180-571ArmodafinilArmodafinilLupin Pharmaceuticals, Inc.ANDACurrent
68180-572ArmodafinilArmodafinilLupin Pharmaceuticals, Inc.ANDACurrent
68180-572ArmodafinilArmodafinilLupin Pharmaceuticals, Inc.ANDACurrent
68180-572ArmodafinilArmodafinilLupin Pharmaceuticals, Inc.ANDACurrent
68180-573ArmodafinilArmodafinilLupin Pharmaceuticals, Inc.ANDACurrent
68180-573ArmodafinilArmodafinilLupin Pharmaceuticals, Inc.ANDACurrent
68180-573ArmodafinilArmodafinilLupin Pharmaceuticals, Inc.ANDACurrent
71335-0681ArmodafinilArmodafinilBryant Ranch PrepackANDACurrent
71335-0681ArmodafinilArmodafinilBryant Ranch PrepackANDACurrent
71335-0681ArmodafinilArmodafinilBryant Ranch PrepackANDACurrent
71335-0710ArmodafinilArmodafinilBryant Ranch PrepackANDACurrent
71335-0710ArmodafinilArmodafinilBryant Ranch PrepackANDACurrent
71335-0710ArmodafinilArmodafinilBryant Ranch PrepackANDACurrent