FDA.reportPublic FDA data

Application 204331

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EZETIMIBEEZETIMIBETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68382-773ezetimibeezetimibeZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-773ezetimibeezetimibeZydus Pharmaceuticals USA Inc.ANDACurrent
68382-773ezetimibeezetimibeZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1109ezetimibeezetimibeCadila Healthcare LimitedANDACurrent
70771-1109ezetimibeezetimibeZydus Lifesciences LimitedANDACurrent
70771-1109ezetimibeezetimibeCadila Healthcare LimitedANDACurrent
70771-1109ezetimibeezetimibeCadila Healthcare LimitedANDACurrent
82009-024ezetimibeezetimibeQuallent Pharmaceuticals Health LLCANDACurrent