FDA.reportPublic FDA data

Application 212016

Type
ANDA
Sponsor
ELITE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NIFEDIPINENIFEDIPINETABLET, EXTENDED RELEASE;ORAL90MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70807-503nifedipinenifedipineElite Pharmaceutical Solution, Inc.ANDACurrent
72214-503nifedipinenifedipineElite pharmaceutical Technology (Shanghai) Co., LtdANDACurrent