FDA.reportPublic FDA data

Application 205031

Type
ANDA
Sponsor
SUN PHARMA GLOBAL

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47335-918LacosamideLacosamideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-918LacosamideLacosamideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-922LacosamideLacosamideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-922LacosamideLacosamideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-943LacosamideLacosamideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-943LacosamideLacosamideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-980LacosamideLacosamideSun Pharmaceutical Industries, Inc.ANDACurrent
47335-980LacosamideLacosamideSun Pharmaceutical Industries, Inc.ANDACurrent