FDA.reportPublic FDA data

Application 206694

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TAMOXIFEN CITRATETAMOXIFEN CITRATETABLET;ORALEQ 10MG BASENoNo
002TAMOXIFEN CITRATETAMOXIFEN CITRATETABLET;ORALEQ 20MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68382-826Tamoxifen CitrateTamoxifen CitrateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-826Tamoxifen CitrateTamoxifen CitrateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-826Tamoxifen CitrateTamoxifen CitrateZydus Pharmaceuticals USA Inc.ANDACurrent
68382-826Tamoxifen CitrateTamoxifen CitrateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-827Tamoxifen CitrateTamoxifen CitrateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-827Tamoxifen CitrateTamoxifen CitrateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-827Tamoxifen CitrateTamoxifen CitrateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-827Tamoxifen CitrateTamoxifen CitrateZydus Pharmaceuticals USA Inc.ANDACurrent
70771-1184Tamoxifen CitrateTamoxifen CitrateCadila Healthcare LimitedANDACurrent
70771-1184Tamoxifen CitrateTamoxifen CitrateCadila Healthcare LimitedANDACurrent
70771-1184Tamoxifen CitrateTamoxifen CitrateZydus Lifesciences LimitedANDACurrent
70771-1184Tamoxifen CitrateTamoxifen CitrateCadila Healthcare LimitedANDACurrent
70771-1185Tamoxifen CitrateTamoxifen CitrateCadila Healthcare LimitedANDACurrent
70771-1185Tamoxifen CitrateTamoxifen CitrateCadila Healthcare LimitedANDACurrent
70771-1185Tamoxifen CitrateTamoxifen CitrateZydus Lifesciences LimitedANDACurrent
70771-1185Tamoxifen CitrateTamoxifen CitrateCadila Healthcare LimitedANDACurrent
71335-1424Tamoxifen CitrateTamoxifen CitrateBryant Ranch PrepackANDACurrent
71335-1424Tamoxifen CitrateTamoxifen CitrateBryant Ranch PrepackANDACurrent