FDA.reportPublic FDA data

Application 215628

Type
ANDA
Sponsor
GLAND PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LACOSAMIDELACOSAMIDESOLUTION;INTRAVENOUS200MG/20ML (10MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68083-480LacosamideLacosamideGland Pharma LimitedANDACurrent
72266-242LacosamideLacosamideFosun Pharma USAANDACurrent