Application Nr Approved Date Route Status External Links
ANDA081235 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Methotrexate Tablets Are A Dihydrofolate Reductase Inhibitor Indicated For The: • Treatment Of Adults And Pediatric Patients With Acute Lymphoblastic Leukemia (All) As Part Of A Combination Chemotherapy Maintenance Regimen ( 1.1 ) • Treatment Of Adults With Mycosis Fungoides ( 1.1 ) • Treatment Of Adults With Relapsed Or Refractory Non-Hodgkin Lymphoma As Part Of A Metronomic Combination Regimen ( 1.1 ) • Treatment Of Adults With Rheumatoid Arthritis ( 1.2 ) • Treatment Of Pediatric Patients With Polyarticular Juvenile Idiopathic Arthritis (Pjia) ( 1.3 ) • Treatment Of Adults With Severe Psoriasis ( 1.4 ) 1.1 Neoplastic Diseases Methotrexate Tablets Are Indicated For The: • Treatment Of Adults And Pediatric Patients With Acute Lymphoblastic Leukemia (All) As Part Of A Combination Chemotherapy Maintenance Regimen . • Treatment Of Adults With Mycosis Fungoides (Cutaneous T-Cell Lymphoma) As A Single Agent Or As Part Of A Combination Chemotherapy Regimen . • Treatment Of Adults With Relapsed Or Refractory Non-Hodgkin Lymphomas As Part Of A Metronomic Combination Chemotherapy Regimen . 1.2 Rheumatoid Arthritis Methotrexate Tablets Are Indicated For The Treatment Of Adults With Rheumatoid Arthritis . 1.3 Polyarticular Juvenile Idiopathic Arthritis Methotrexate Tablets Are Indicated For The Treatment Of Pediatric Patients With Polyarticular Juvenile Idiopathic Arthritis (Pjia) . 1.4 Psoriasis Methotrexate Tablets Are Indicated For The Treatment Of Adults With Severe Psoriasis .

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Methotrexate Sodium METHOTREXATE SODIUM ZINC1529323

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