FDA.reportPublic FDA data

Application 074642

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDECAPSULE;ORAL20MGNoNo
002NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDECAPSULE;ORAL30MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-1020Nicardipine Hydrochloridenicardipine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-1020Nicardipine Hydrochloridenicardipine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-1430Nicardipine Hydrochloridenicardipine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
0378-1430Nicardipine Hydrochloridenicardipine hydrochlorideMylan Pharmaceuticals Inc.ANDACurrent
68151-0092Nicardipine Hydrochloridenicardipine hydrochlorideCarilion Materials ManagementANDACurrent
68151-0093Nicardipine Hydrochloridenicardipine hydrochlorideCarilion Materials ManagementANDACurrent