Application 216357

Type
ANDA
Sponsor
GLENMARK PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDECAPSULE;ORAL20MGNoNo
002NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDECAPSULE;ORAL30MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68462-120Nicardipine HydrochlorideNicardipine HydrochlorideGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-121Nicardipine HydrochlorideNicardipine HydrochlorideGlenmark Pharmaceuticals Inc., USAANDACurrent