FDA.reportPublic FDA data

Application 208308

Type
ANDA
Sponsor
INDOCO

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
14445-129LacosamideLacosamideIndoco Remedies LimitedANDACurrent
14445-130LacosamideLacosamideIndoco Remedies LimitedANDACurrent
14445-131LacosamideLacosamideIndoco Remedies LimitedANDACurrent
14445-132LacosamideLacosamideIndoco Remedies LimitedANDACurrent
16714-548LacosamideLacosamideNorthStar RxLLCANDACurrent
16714-548LacosamideLacosamideNorthStar RxLLCANDACurrent
16714-549LacosamideLacosamideNorthStar RxLLCANDACurrent
16714-549LacosamideLacosamideNorthStar RxLLCANDACurrent
16714-550LacosamideLacosamideNorthStar RxLLCANDACurrent
16714-550LacosamideLacosamideNorthStar RxLLCANDACurrent
16714-552LacosamideLacosamideNorthStar RxLLCANDACurrent
16714-552LacosamideLacosamideNorthStar RxLLCANDACurrent
27808-243LacosamideLacosamideTris Pharma IncANDACurrent
27808-243LacosamideLacosamideTris Pharma IncANDACurrent
27808-244LacosamideLacosamideTris Pharma IncANDACurrent
27808-244LacosamideLacosamideTris Pharma IncANDACurrent
27808-245LacosamideLacosamideTris Pharma IncANDACurrent
27808-245LacosamideLacosamideTris Pharma IncANDACurrent
27808-246LacosamideLacosamideTris Pharma IncANDACurrent
27808-246LacosamideLacosamideTris Pharma IncANDACurrent