Application Nr Approved Date Route Status External Links
ANDA210892 None Intravenous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Levoleucovorin Injection Is A Folate Analog. Levoleucovorin Injection Rescue Is Indicated After High-Dose Methotrexate Therapy In Osteosarcoma. Levoleucovorin Injection Is Also Indicated To Diminish The Toxicity And Counteract The Effects Of Impaired Methotrexate Elimination And Of Inadvertent Overdosage Of Folic Acid Antagonists. Levoleucovorin Injection Is Indicated For Use In Combination Chemotherapy With 5-Fluorouracil In The Palliative Treatment Of Patients With Advanced Metastatic Colorectal Cancer. Levoleucovorin Injection Is A Folate Analog Indicated For: • Rescue After High-Dose Methotrexate Therapy In Osteosarcoma. • Diminishing The Toxicity And Counteracting The Effects Of Impaired Methotrexate Elimination And Of Inadvertent Overdosage Of Folic Acid Antagonists. • Use In Combination Chemotherapy With 5-Fluorouracil In The Palliative Treatment Of Patients With Advanced Metastatic Colorectal Cancer.(1) Limitations Of Use Levoleucovorin Injection Is Not Approved For Pernicious Anemia And Megaloblastic Anemias. Improper Use May Cause A Hematologic Remission While Neurologic Manifestations Continue To Progress. (1.1) 1.1 Limitations Of Use Levoleucovorin Injection Is Not Approved For Pernicious Anemia And Megaloblastic Anemias Secondary To The Lack Of Vitamin B 12 .improper Use May Cause A Hematologic Remission While Neurologic Manifestations Continue To Progress.

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Levoleucovorin Calcium LEVOLEUCOVORIN CALCIUM ZINC9212427

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