Application 214035

Type
ANDA
Sponsor
VKT PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RANOLAZINERANOLAZINETABLET, EXTENDED RELEASE;ORAL500MGNoNo
002RANOLAZINERANOLAZINETABLET, EXTENDED RELEASE;ORAL1GMNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42385-963RanolazineRanolazineLaurus Generics Inc.ANDACurrent
42385-964RanolazineRanolazineLaurus Generics Inc.ANDACurrent