FDA.reportPublic FDA data

Application 211121

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

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
55150-183NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDEAuroMedics Pharma LLCANDACurrent
55150-183NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDEAuroMedics Pharma LLCANDACurrent
55150-183NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDEAuroMedics Pharma LLCANDACurrent