FDA.reportPublic FDA data

Application 090752

Type
ANDA
Sponsor
CHINA RESOURCES

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMLODIPINE BESYLATEAMLODIPINE BESYLATETABLET;ORALEQ 5MG BASENoNo
002AMLODIPINE BESYLATEAMLODIPINE BESYLATETABLET;ORALEQ 10MG BASENoNo
003AMLODIPINE BESYLATEAMLODIPINE BESYLATETABLET;ORALEQ 2.5MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43489-100Amlodipine BesylateAmlodipine BesylateSecan Pharmaceuticals, Inc.ANDACurrent
43489-100Amlodipine BesylateAmlodipine BesylateChina Resources Saike Pharmaceutical Co., Ltd.ANDACurrent
43489-100Amlodipine BesylateAmlodipine BesylateChina Resources Saike Pharmaceutical Co., Ltd.ANDACurrent
43489-100Amlodipine BesylateAmlodipine BesylateChina Resources Saike Pharmaceutical Co., Ltd.ANDACurrent
43489-101Amlodipine BesylateAmlodipine BesylateSecan Pharmaceuticals, Inc.ANDACurrent
43489-101Amlodipine BesylateAmlodipine BesylateChina Resources Saike Pharmaceutical Co., Ltd.ANDACurrent
43489-101Amlodipine BesylateAmlodipine BesylateChina Resources Saike Pharmaceutical Co., Ltd.ANDACurrent
43489-101Amlodipine BesylateAmlodipine BesylateChina Resources Saike Pharmaceutical Co., Ltd.ANDACurrent
43489-102Amlodipine BesylateAmlodipine BesylateSecan Pharmaceuticals, Inc.ANDACurrent
43489-102Amlodipine BesylateAmlodipine BesylateChina Resources Saike Pharmaceutical Co., Ltd.ANDACurrent
43489-102Amlodipine BesylateAmlodipine BesylateChina Resources Saike Pharmaceutical Co., Ltd.ANDACurrent
43489-102Amlodipine BesylateAmlodipine BesylateChina Resources Saike Pharmaceutical Co., Ltd.ANDACurrent