FDA.reportPublic FDA data

Application 090125

Type
ANDA
Sponsor
NAVINTA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDEINJECTABLE;INJECTION25MG/10ML (2.5MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-3204Nicardipine HydrochlorideNicardipine HydrochlorideSandoz Inc.ANDACurrent
0781-9324Nicardipine HydrochlorideNicardipine HydrochlorideSandoz Inc.ANDACurrent
14593-124Nicardipine HydrochlorideNicardipine HydrochlorideEmcure Pharmaceuticals Ltd.ANDACurrent