FDA.reportPublic FDA data

Application 202644

Type
ANDA
Sponsor
HERITAGE PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NIFEDIPINENIFEDIPINECAPSULE;ORAL10MGNoNo
002NIFEDIPINENIFEDIPINECAPSULE;ORAL20MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-7229NifedipineNifedipineMajor PharmaceuticalsANDACurrent
23155-194NifedipineNifedipineHeritage Pharmaceuticals Inc.ANDACurrent
23155-194NifedipineNifedipineHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-194NifedipineNifedipineHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-195NifedipineNifedipineHeritage Pharmaceuticals Inc.ANDACurrent
23155-195NifedipineNifedipineHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-195NifedipineNifedipineHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
72789-219NifedipineNifedipinePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-219NifedipineNifedipinePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-219NifedipineNifedipinePD-Rx Pharmaceuticals, Inc.ANDACurrent