FDA.reportPublic FDA data

Application 214695

Type
ANDA
Sponsor
ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LACOSAMIDELACOSAMIDEUNKNOWNUNKNOWNNoNo
002LACOSAMIDELACOSAMIDETABLET;ORAL100MGNoNo
003LACOSAMIDELACOSAMIDETABLET;ORAL150MGNoNo
004LACOSAMIDELACOSAMIDETABLET;ORAL200MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-7244LacosamideLacosamideMajor PharmaceuticalsANDACurrent
0904-7245LacosamideLacosamideMajor PharmaceuticalsANDACurrent
0904-7246LacosamideLacosamideMajor PharmaceuticalsANDACurrent
0904-7247LacosamideLacosamideMajor PharmaceuticalsANDACurrent
60687-676LacosamideLacosamideAmerican Health PackagingANDACurrent
60687-687LacosamideLacosamideAmerican Health PackagingANDACurrent
60687-698LacosamideLacosamideAmerican Health PackagingANDACurrent
67877-733LacosamideLacosamideAscend Laboratories, LLCANDACurrent
67877-734LacosamideLacosamideAscend Laboratories, LLCANDACurrent
67877-735LacosamideLacosamideAscend Laboratories, LLCANDACurrent
67877-736LacosamideLacosamideAscend Laboratories, LLCANDACurrent