FDA.reportPublic FDA data

Application 090671

Type
ANDA
Sponsor
WOCKHARDT

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
55648-631Nicardipine HydrochlorideNicardipine HydrochlorideWockhardt LimitedANDACurrent
64679-631Nicardipine HydrochlorideNicardipine HydrochlorideWockhardt USA LLC.ANDACurrent
64679-631Nicardipine HydrochlorideNicardipine HydrochlorideWockhardt USA LLC.ANDACurrent