FDA.reportPublic FDA data

Application 040054

Type
ANDA
Sponsor
HIKMA

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-4550Methotrexate SodiumMethotrexate SodiumWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-4550Methotrexate SodiumMethotrexate SodiumWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-4550Methotrexate SodiumMethotrexate SodiumWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-4550Methotrexate SodiumMethotrexate SodiumWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-8550Methotrexate SodiumMethotrexate SodiumWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-8550Methotrexate SodiumMethotrexate SodiumWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-8550Methotrexate SodiumMethotrexate SodiumWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-8550Methotrexate SodiumMethotrexate SodiumWest-Ward Pharmaceuticals Corp.ANDACurrent
63629-1472Methotrexate SodiumMethotrexate SodiumBryant Ranch PrepackANDACurrent
63629-1472Methotrexate SodiumMethotrexate SodiumBryant Ranch PrepackANDACurrent
70518-2711Methotrexate SodiumMethotrexate SodiumREMEDYREPACK INC.ANDACurrent
70518-2711Methotrexate SodiumMethotrexate SodiumREMEDYREPACK INC.ANDACurrent
70518-2711Methotrexate SodiumMethotrexate SodiumREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
66484SUPPL2021-03-04
66483SUPPL2021-03-04
66482SUPPL2021-03-04
66328SUPPL2021-02-23
66327SUPPL2021-02-23
66326SUPPL2021-02-23