FDA.reportPublic FDA data

Application 090258

Type
ANDA
Sponsor
HANGZHOU BINJIANG

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALENDRONATE SODIUMALENDRONATE SODIUMTABLET;ORALEQ 5MG BASENoNo
002ALENDRONATE SODIUMALENDRONATE SODIUMTABLET;ORALEQ 10MG BASENoNo
003ALENDRONATE SODIUMALENDRONATE SODIUMTABLET;ORALEQ 35MG BASENoNo
004ALENDRONATE SODIUMALENDRONATE SODIUMTABLET;ORALEQ 70MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10135-696AlendronateAlendronate SodiumMarlex Pharmaceuticals IncANDACurrent
10135-697AlendronateAlendronate SodiumMarlex Pharmaceuticals IncANDACurrent
10135-718AlendronateAlendronate sodium tabletMarlex Pharmaceuticals, Inc.ANDACurrent
10135-718AlendronateAlendronate sodium tabletMarlex Pharmaceuticals, Inc.ANDACurrent
10135-718AlendronateAlendronate sodium tabletMarlex Pharmaceuticals, Inc.ANDACurrent
10135-719AlendronateAlendronate sodium tabletMarlex Pharmaceuticals, Inc.ANDACurrent
10135-719AlendronateAlendronate sodium tabletMarlex Pharmaceuticals, Inc.ANDACurrent
10135-719AlendronateAlendronate sodium tabletMarlex Pharmaceuticals, Inc.ANDACurrent
50090-2587AlendronateALENDRONATE SODIUMA-S Medication SolutionsANDACurrent
50090-3593AlendronateALENDRONATE SODIUMA-S Medication SolutionsANDACurrent
50090-3593AlendronateALENDRONATE SODIUMA-S Medication SolutionsANDACurrent
60429-055Alendronate SodiumAlendronate SodiumGolden State Medical Supply, Inc.ANDACurrent
60429-055Alendronate SodiumAlendronate SodiumGolden State Medical Supply, Inc.ANDACurrent
60429-056Alendronate SodiumAlendronate SodiumGolden State Medical Supply, Inc.ANDACurrent
60429-056Alendronate SodiumAlendronate SodiumGolden State Medical Supply, Inc.ANDACurrent
60723-205AlendronateALENDRONATE SODIUMHangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.ANDACurrent
60723-205AlendronateALENDRONATE SODIUMHangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.ANDACurrent
60723-205AlendronateALENDRONATE SODIUMHangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.ANDACurrent
60723-205AlendronateALENDRONATE SODIUMHangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.ANDACurrent
60723-205AlendronateALENDRONATE SODIUMHangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.ANDACurrent
60723-207AlendronateALENDRONATE SODIUMHangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.ANDACurrent
60723-207AlendronateALENDRONATE SODIUMHangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.ANDACurrent
60723-207AlendronateALENDRONATE SODIUMHangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.ANDACurrent
60723-207AlendronateALENDRONATE SODIUMHangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.ANDACurrent
60723-207AlendronateALENDRONATE SODIUMHangzhou Minsheng Binjiang Pharmaceutical Co., Ltd.ANDACurrent
63629-7329AlendronateALENDRONATE SODIUMBryant Ranch PrepackANDACurrent
63629-7329AlendronateALENDRONATE SODIUMBryant Ranch PrepackANDACurrent
63629-7329AlendronateALENDRONATE SODIUMBryant Ranch PrepackANDACurrent
68071-4017AlendronateALENDRONATE SODIUMNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4017AlendronateALENDRONATE SODIUMNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4072AlendronateALENDRONATE SODIUMNuCare Pharmaceuticals,Inc.ANDACurrent
69543-130AlendronateALENDRONATE SODIUMVirtus PharmaceuticalsANDACurrent
69543-130AlendronateALENDRONATE SODIUMVirtus PharmaceuticalsANDACurrent
69543-130AlendronateALENDRONATE SODIUMVirtus PharmaceuticalsANDACurrent
69543-130AlendronateALENDRONATE SODIUMVirtus PharmaceuticalsANDACurrent
69543-130AlendronateALENDRONATE SODIUMVirtus PharmaceuticalsANDACurrent
69543-130AlendronateALENDRONATE SODIUMVirtus PharmaceuticalsANDACurrent
69543-131AlendronateALENDRONATE SODIUMVirtus PharmaceuticalsANDACurrent
69543-131AlendronateALENDRONATE SODIUMVirtus PharmaceuticalsANDACurrent
69543-131AlendronateALENDRONATE SODIUMVirtus PharmaceuticalsANDACurrent
69543-131AlendronateALENDRONATE SODIUMVirtus PharmaceuticalsANDACurrent
69543-131AlendronateALENDRONATE SODIUMVirtus PharmaceuticalsANDACurrent
69543-131AlendronateALENDRONATE SODIUMVirtus PharmaceuticalsANDACurrent