FDA.reportPublic FDA data

Application 206750

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TEMOZOLOMIDETEMOZOLOMIDECAPSULE;ORAL5MGNoNo
002TEMOZOLOMIDETEMOZOLOMIDECAPSULE;ORAL20MGNoNo
003TEMOZOLOMIDETEMOZOLOMIDECAPSULE;ORAL100MGNoNo
004TEMOZOLOMIDETEMOZOLOMIDECAPSULE;ORAL140MGNoNo
005TEMOZOLOMIDETEMOZOLOMIDECAPSULE;ORAL180MGNoNo
006TEMOZOLOMIDETEMOZOLOMIDECAPSULE;ORAL250MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68382-751temozolomidetemozolomideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-751temozolomidetemozolomideZydus Pharmaceuticals USA Inc.ANDACurrent
68382-751temozolomidetemozolomideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-751temozolomidetemozolomideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-751temozolomidetemozolomideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-752temozolomidetemozolomideZydus Pharmaceuticals USA Inc.ANDACurrent
68382-752temozolomidetemozolomideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-752temozolomidetemozolomideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-752temozolomidetemozolomideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-752temozolomidetemozolomideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-753temozolomidetemozolomideZydus Pharmaceuticals USA Inc.ANDACurrent
68382-753temozolomidetemozolomideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-753temozolomidetemozolomideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-753temozolomidetemozolomideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-753temozolomidetemozolomideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-754temozolomidetemozolomideZydus Pharmaceuticals USA Inc.ANDACurrent
68382-754temozolomidetemozolomideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-754temozolomidetemozolomideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-754temozolomidetemozolomideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-754temozolomidetemozolomideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-755temozolomidetemozolomideZydus Pharmaceuticals USA Inc.ANDACurrent
68382-755temozolomidetemozolomideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-755temozolomidetemozolomideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-755temozolomidetemozolomideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-755temozolomidetemozolomideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-756temozolomidetemozolomideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-756temozolomidetemozolomideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-756temozolomidetemozolomideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-756temozolomidetemozolomideZydus Pharmaceuticals USA Inc.ANDACurrent
68382-756temozolomidetemozolomideZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1092temozolomidetemozolomideCadila Healthcare LimitedANDACurrent
70771-1092temozolomidetemozolomideCadila Healthcare LimitedANDACurrent
70771-1092temozolomidetemozolomideZydus Lifesciences LimitedANDACurrent
70771-1092temozolomidetemozolomideCadila Healthcare LimitedANDACurrent
70771-1093temozolomidetemozolomideCadila Healthcare LimitedANDACurrent
70771-1093temozolomidetemozolomideCadila Healthcare LimitedANDACurrent
70771-1093temozolomidetemozolomideZydus Lifesciences LimitedANDACurrent
70771-1093temozolomidetemozolomideCadila Healthcare LimitedANDACurrent
70771-1094temozolomidetemozolomideCadila Healthcare LimitedANDACurrent
70771-1094temozolomidetemozolomideZydus Lifesciences LimitedANDACurrent
70771-1094temozolomidetemozolomideCadila Healthcare LimitedANDACurrent
70771-1094temozolomidetemozolomideCadila Healthcare LimitedANDACurrent
70771-1095temozolomidetemozolomideCadila Healthcare LimitedANDACurrent
70771-1095temozolomidetemozolomideCadila Healthcare LimitedANDACurrent
70771-1095temozolomidetemozolomideZydus Lifesciences LimitedANDACurrent
70771-1095temozolomidetemozolomideCadila Healthcare LimitedANDACurrent
70771-1096temozolomidetemozolomideCadila Healthcare LimitedANDACurrent
70771-1096temozolomidetemozolomideCadila Healthcare LimitedANDACurrent
70771-1096temozolomidetemozolomideZydus Lifesciences LimitedANDACurrent
70771-1096temozolomidetemozolomideCadila Healthcare LimitedANDACurrent
70771-1097temozolomidetemozolomideCadila Healthcare LimitedANDACurrent
70771-1097temozolomidetemozolomideCadila Healthcare LimitedANDACurrent
70771-1097temozolomidetemozolomideZydus Lifesciences LimitedANDACurrent
70771-1097temozolomidetemozolomideCadila Healthcare LimitedANDACurrent