FDA.reportPublic FDA data

Application 090534

Type
ANDA
Sponsor
AM REGENT

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
0517-0735Nicardipine Hydrochloridenicardipine hydrochlorideAmerican Regent, Inc.ANDACurrent
0517-0735Nicardipine Hydrochloridenicardipine hydrochlorideAmerican Regent, Inc.ANDACurrent
0517-0735Nicardipine Hydrochloridenicardipine hydrochlorideAmerican Regent, Inc.ANDACurrent
0517-0735Nicardipine Hydrochloridenicardipine hydrochlorideAmerican Regent, Inc.ANDACurrent
40042-047Nicardipine HydrochlorideNicardipine HydrochloridePharmaForce, Inc.ANDACurrent
72572-470Nicardipine Hydrochloridenicardipine hydrochlorideCivica, Inc.ANDACurrent