FDA.reportPublic FDA data

Application 207812

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METHOTREXATE SODIUMMETHOTREXATE SODIUMTABLET;ORALEQ 2.5MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-7141MethotrexateMethotrexateMajor PharmaceuticalsANDACurrent
0904-7141MethotrexateMethotrexateMajor PharmaceuticalsANDACurrent
68382-775MethotrexateMethotrexateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-775MethotrexateMethotrexateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-775MethotrexateMethotrexateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-775MethotrexateMethotrexateZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-775MethotrexateMethotrexateZydus Pharmaceuticals USA Inc.ANDACurrent
70518-1398MethotrexateMethotrexateREMEDYREPACK INC.ANDACurrent
70518-1398MethotrexateMethotrexateREMEDYREPACK INC.ANDACurrent
70518-1398MethotrexateMethotrexateREMEDYREPACK INC.ANDACurrent
70518-1398MethotrexateMethotrexateREMEDYREPACK INC.ANDACurrent
70518-1398MethotrexateMethotrexateREMEDYREPACK INC.ANDACurrent
70518-1398MethotrexateMethotrexateREMEDYREPACK INC.ANDACurrent
70518-1398MethotrexateMethotrexateREMEDYREPACK INC.ANDACurrent
70518-1398MethotrexateMethotrexateREMEDYREPACK INC.ANDACurrent
70771-1058MethotrexateMethotrexateZydus Lifesciences LimitedANDACurrent
70771-1058MethotrexateMethotrexateCadila Healthcare LimitedANDACurrent
70771-1058MethotrexateMethotrexateCadila Healthcare LimitedANDACurrent
70771-1058MethotrexateMethotrexateCadila Healthcare LimitedANDACurrent