FDA.reportPublic FDA data

Application 210058

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMBRISENTANAMBRISENTANTABLET;ORAL5MGNoNo
002AMBRISENTANAMBRISENTANTABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70710-1179AmbrisentanAmbrisentanZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1179AmbrisentanAmbrisentanZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1179AmbrisentanAmbrisentanZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1179AmbrisentanAmbrisentanZydus Pharmaceuticals USA Inc.ANDACurrent
70710-1179AmbrisentanAmbrisentanZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1180AmbrisentanAmbrisentanZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1180AmbrisentanAmbrisentanZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1180AmbrisentanAmbrisentanZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1180AmbrisentanAmbrisentanZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1180AmbrisentanAmbrisentanZydus Pharmaceuticals USA Inc.ANDACurrent
70771-1363AmbrisentanAmbrisentanCadila Healthcare LimitedANDACurrent
70771-1363AmbrisentanAmbrisentanCadila Healthcare LimitedANDACurrent
70771-1363AmbrisentanAmbrisentanCadila Healthcare LimitedANDACurrent
70771-1363AmbrisentanAmbrisentanCadila Healthcare LimitedANDACurrent
70771-1363AmbrisentanAmbrisentanZydus Lifesciences LimitedANDACurrent
70771-1364AmbrisentanAmbrisentanCadila Healthcare LimitedANDACurrent
70771-1364AmbrisentanAmbrisentanZydus Lifesciences LimitedANDACurrent
70771-1364AmbrisentanAmbrisentanCadila Healthcare LimitedANDACurrent
70771-1364AmbrisentanAmbrisentanCadila Healthcare LimitedANDACurrent
70771-1364AmbrisentanAmbrisentanCadila Healthcare LimitedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76416ORIG 2023-11-06
58169APPL2019-04-01
58159ORIG2019-04-01